Tuesday, July 30, 2013

California Stem Cell Agency Looking for New Home in Two Years

The California stem cell agency is located south of Market Street in San
 Francisco, close to the San Francisco Giants ballpark(upper right).  Since
 the agency has been there, the area has grown from seedy to gentrified. 
Some not-so-good news surfaced today in San Francisco involving the $3 billion California stem cell agency.

The news has little to do with its science efforts but everything to do with where it is located and its overhead expenses. The agency will be forced out of its free office space – 20,000 square feet – in two years. The free space was provided under an $18 million recruitment package and is worth at least $1 million a year, according to the agency's auditors.

The bad news is that the San Francisco office-space market is sizzling hot. Google, Yahoo, Microsoft and other technology firms are scrambling for space in Baghdad-by-the-Bay, as the city is sometimes known. According to a story this morning by James Temple in the San Francisco Chronicle, the firms are looking for a total of about 800,000 square feet and are prepared to pay well for it.

One nearly completed deal involving Yahoo would cost about $48 per square foot for a 10-year lease. If CIRM paid at that rate, it would have nearly $1 million in additional costs annually. However, leasing rates are expected to rise substantially in the next year or so. Also involved in a move would be the cost of parking, which could run about $360,000 a year.

The stem cell agency is already examining its options for new offices, including some sort of special deal with the City of San Francisco.

Former State Sen. Art Torres, onetime chairman of the state Democratic Party and co-vice chairman of CIRM, briefed agency directors on the matter at its meeting in May. He said,
“I met with the mayor of San Francisco(Ed Lee), who's a dear friend, and he encouraged us to be aware that he's very committed to helping us find some space in San Francisco. Whether it means tax credits or incentives to a potential landlord, we still have to work that out. Obviously we still have to work out what the space will be. But the fact that the mayor has indicated very explicitly that he wants to keep us in San Francisco, I think it will bode well for us down the road.

“The current owner of the property (Stockbridge Capital Partners) has not been happy that for ten years they've had to supply free rent to us. And what they didn't anticipate was having to provide for over $755,000 in operating costs, which they thought some donors would take are of. Those donors -- some of whom passed away and others who chose to give money to other institutions, UC San Francisco, in particular, to the stem cell lab, which was very much appreciated, I know, by UCSF – but at the end of the day, there's no room for negotiations with this current owner.”
CIRM Director Joan Samuelson asked Torres whether future rent would also be free. Torres, who is also president of San Francisco's Public Utilities Commission, replied,
“I would not work on that assumption. I would work on the assumption somewhere between a dollar and more, again, dependent upon what kind of tax incentives the City of San Francisco would provide. We're very fortunate that my son(Joaquin Torres) is the deputy mayor for economic development, so we also have him working on this as well.”
Samuelson replied,
“I'll ask more questions offline.”

Friday, July 26, 2013

California Stem Cell Official Duane Roth in Improving Condition

Duane Roth, the co-vice chairman of the California stem cell agency, is improving after he was hospitalized for treatment of a serious brain injury sustained in a bicycle accident Sunday in the mountains east of San Diego.

According to a report on Xconomy.com, Roth's brother, Ted, said yesterday, 
“Were certainly moving in the right direction. We're now looking at the recovery phase.”
The article by Bruce Bigelow said Roth has passed through the most critical period following surgery at the UC San Diego hospital.

Roth, the 63-year-old CEO of the San Diego technology organization, Connect, is in serious condition in a medically induced coma.

The governing board of the California stem cell agency yesterday took special note of Roth at its meeting and sent its best wishes to him and his family.  

Thursday, July 25, 2013

Stem Cell Agency Board Concludes Meeting

The governing board of the California stem cell agency concluded its meeting today at 2:33 p.m. PDT. The California Stem Cell Report has also concluded its coverage today's session.

CIRM Posts Alpha Clinic Press Release

The California stem cell agency this afternoon posted its press release on the $70 million Alpha stem cell clinic plan. Here is where it can be found.

Another $23 Million to Recruit Star Stem Cell Scientists to California

California's $46 million effort to lure stem cell research stars to the Golden State was expanded today by another $23 million.

Directors of the stem cell agency approved the funds on a 14-4-1 vote. CIRM directors Jeff Sheehy and Francisco Prieto were among those opposing the move. Prieto declared,
“We are coming up against finite resources. We have better ways to spend our money."
 Sheehy said that CIRM is contributing to inflation in stem cell science with its lucrative recruitment grants. 

Those supporting the expansion said that the grants have had a great impact on the field, not only bringing in individual scientists, but accompanying researchers in their labs along with grants from other sources.

The additional funds will go to institutions that have not already benefited from one of the earlier grants in the program. Up to four awards are expected to be made.

The CIRM staff proposal on the plan said,
“A number of California institutions have not yet been able to secure a confirmed Research Leadership award but would benefit greatly from the recruitment of emerging or established leaders in stem cell biology. Participation in the CIRM program could bring additional, exceptional researchers to California, strengthen and synergize with other efforts to build up local sustained research communities in stem cell biology and medicine and provide ongoing leadership at the cutting edge of California regenerative medicine.”
All of the California institutions involved with the winning researchers have representatives on the governing board of the stem cell agency. They are not allowed, however, to vote on grants to their institutions or researchers -- only on proposals such as today's $23 expansion.

Applications are due in January with final approval scheduled for next May. The program is not open to businesses.

$35 Million Research Grant Round to Remove Stem Cell Roadblocks

Directors of the California stem cell agency today approved a $35 million program aimed at removing bottlenecks to pushing stem cell therapies into the marketplace.

The plan would provide grants of up$1.2 million for about 20 awards with competition open to both business and non-profit institutions. Pre-applications are expected to be due in October with approval next summer.

California Stem Cell Agency Launches $70 Million Alpha Stem Cell Clinic Project

The California stem cell agency today approved a $70 million plan to create a network of “Alpha” stem cell clinics that is aimed at making the Golden State one of the leading purveyors and developers of stem cell therapies in the world.

The 29-member governing board of the California Institute for Regenerative Medicine (CIRM)adopted the plan on a 19-1 vote. The negative vote came from Joan Samuelson, who questioned whether the plan was premature and whether existing scientific research justified development of the clinics. 

Sherry Lansing, a patient advocate board member and former head of a Hollywood studio, said the proposal is “one of the most exciting proposals that we have ever had in front of us.” She said it was the “beginning of this dream coming true.”

Under the far-reaching proposal, which CIRM President Alan Trounson has been promoting for two years, the agency will finance five stem cell clinics at established institutions in California with grants of up to $11 million. Another $15 million will be allotted for a stem cell information and coordination center. Major matching contributions will be expected from award winners over the five-year terms of the grants.

The effort is aimed at drawing in clinical trials and patients from the around the world and creating a central bank of knowledge, know-how and regulatory expertise. It will also guide efforts to build profits into stem cell therapies and to develop strategies to attract investors and philanthropists. (For more information on the plan, see here, here, here, here and here.)

Trounson said in a statement,
“These clinics have the potential to revolutionize how we deliver stem cell therapies to patients. Stem cell therapies are a completely new way of treating diseases and disorders so we need a completely new way of delivering those in a safe and effective manner. These clinics will help us do just that and the clinical trials carried out in this network will fulfill the agency’s promise of bringing new therapies to patients who need them.” 
The journal Nature Medicine has reported that the Alpha clinics would be the first-ever “clinical trials network focused around a broad therapeutic platform.”

The CIRM board heard no negative comment on the plan other than the remarks by Samuelson. . However, not everyone sees a need for it. Mahendra Rao, director of the Center for Regenerative Medicine at the National Institutes of Health(NIH) , says its surveys of researchers have not shown a demand for such centers. In May, a researcher at institution that likely would be an applicant filed a blistering, anonymous comment on the California Stem Cell Report, describing it as a "boondoggle" and "irresponsible." The scientist said,
“Another boondoggle for some medical schools but made to order for private operators like for-profit cancer, dialysis, and laser eye specialty clinics that do one procedure.  I can see each of the medical schools gifted with one as they each were gifted with about 25 million dollars for stem cell institute buildings.”
The researcher continued,
“The NIH at various times has tried to organize clinical trials groups with infrastructure, like quick reaction forces, ready to gear up for a new trial at the drop of a hat. They mainly did nothing but suck money, kept staff employed, because there are generally few drugs ready for early human trials and each treatment that is brought along requires a unique contract, ethics reviews, and different facilities, equipment and staff than planned for.  The latest incarnation are CTSAs or CTSIs, clinical and translational science centers funded by the federal NIH that most if not all California medical schools already have.”
The RFA for the proposal is expected to go out in October and approval of funding coming one year from now. Here is the link to today's CIRM press release on the plan. 

Alpha Clinic Applicant Qualifications

The chart above outlines the criteria for applicants for grants in the $70 million Alpha clinic plan.

Stem Cell Directors Take Up $70 Million Alpha Clinic Proposal

Directors of the California stem cell agency have begun discussion of the $70 million Alpha stem cell clinic plan. The staff is laying out the proposal at this hour.

California Stem Cell Agency Has $577 Million Remaining for New Research Awards Out of $3 Billion

The California stem cell agency has only $577 million left for future research awards over the next four years, its directors were told this morning.

The figure was reported by CIRM staff this morning as part of its regular briefing on the financial status of the research effort, which began work in 2004 with $3 billion that the state is borrowing through issuance of state bonds. The method of funding will cost roughly $3 billion more in interest costs.

The agency expects to run out of funds for new grants late in 2017 and is considering ways to raise cash for future operations..


Stem Cell Directors Begin Meeting with Report from Alan Trounson

Today's meeting of the governing board of the California stem cell agency began at 9:35 a.m. today with a a report from chairman J.T. Thomas, updating the board on his activities. CIRM President Alan Trounson has now begun his report dealing with stem cell research publications over the last few months.

California Stem Cell Board Meeting Delayed

The business portion of today's meeting of the governing board of the California stem cell agency was scheduled to begin at 9 a.m. PDT. However, that session has been delayed as the board hears a presentation on MS. The business session may begin about 15 minutes or so.

Coming Up: Live Coverage of Today's California Stem Cell Meeting

The California Stem Cell Report will provide live, wall-to-wall coverage of today's meeting of the governing board of the $3 billion California stem cell agency.

At the top of the agenda is a $70 million proposal aimed at creating a string of Alpha stem cell clinics in California that would serve as a foundation for the state's stem cell business. Also on tap are other proposed grant programs, including a $23 million expansion of a researcher recruitment effort and a $35 million round aimed at removing roadblocks to turning research into cures.

Stories will be filed as warranted throughout the day based on the Internet audiocast of the proceedings. 

Interested parties can also listen in on the meeting via the Internet. Instructions can be found on the agenda.  

Wednesday, July 24, 2013

Stem Cell Lines and Paid-for Eggs: Stem Cell Agency Delays Action on Easing Restrictions

A key panel of the California stem cell agency today balked at approving a plan to ease restrictions on using stem cell lines derived from women who were paid for their eggs.

The proposal had been scheduled to be taken up tomorrow by the governing board of the $3 billion agency, but the board's standards working group delayed action.

In response to a question, Kevin McCormack, a spokesman for the agency, said in an email,
“It was felt that more discussion was needed before moving to a vote so another meeting is going to be scheduled.”
In 2006, the CIRM governing board approved regulations that banned the use of CIRM funds for stem cells lines derived using compensation. That rule would be modified under today's plan, which would permit the CIRM governing board to approve the use of such lines following a staff study evaluating scientific and ethical issues. Their use would be allowed if the lines would “advance CIRM's mission.”

The delay came after four organizations, including the Center for Genetics and Society in Berkeley, argued that the plan is vague and did not adequately address safety issues.

The four-page statement by the groups said that the plan does not appear to have met “numerous concerns” raised in 2009 in a document co-authored by the CIRM staff. Those concerns include long-term risk and ethical issues.

Under the proposal, the groups said that the agency governing board
“...will decide whether to approve a grantee’s request to use a stem cell line created with paid-for eggs on the basis of whether doing so 'will advance CIRM’s mission.' This criterion is much too vague, and doesn’t include consideration of the health or welfare of the women who undergo egg retrieval. Protecting the well-being of women providing eggs is not even mentioned (though perhaps it could be considered as an element of the fifth of five 'factors to be considered by the ICOC(the agency board),' 'whether the donation…was consistent with `best practices’ at the time of donation').”
The standards group also heard from a UCLA researcher who argued on behalf of the change. Kathrin Plath said she and her colleagues wanted to use a paid-for stem cell line from the Oregon experiment that cloned human stem cells.
(An earlier version of this item said the change under consideration would ease restrictions on "purchasing" stem cell lines. The word "purchasing" was changed to "using.")
Here is the text of the statement by the four organizations.

$70 Million Alpha Stem Cell Clinic Project Garners Mainstream Media Attention

California's $70 million plan for a chain of “Alpha” stem cell clinics today received its first major attention from the mainstream media.

The story came in the state's largest circulation newspaper, appearing this morning on the home page of the website of Los Angeles Times.

The Alpha project would create five clinics around the state and a coordination/information center under a concept that comes before the governing board of the state's $3 billion stem cell agency at its meeting tomorrow in Burlingame, Ca. Funds could be awarded as early as a year from now. (For more information, see here and here.)

Reporter Eryn Brown quoted Natalie DeWitt, special projects officer for CIRM, as the stem cell agency is known, and Maria Millan, a CIRM medical officer. Brown wrote,
“Clinics to conduct trials of stem cell therapies have different needs than clinics designed to deliver conventional therapies, DeWitt and Millan said. They need special facilities for handling the cells safely, as well as imaging equipment to track the cells once they're delivered into a patient’s body.  Some of this infrastructure already exists, but other parts of it still need to be perfected.  Establishing clinics to house multiple trials might create the critical mass needed to get the infrastructure in place, they said....
"Additionally, they said, CIRM hopes that such collaboration would encourage stem cell companies to share information -- speeding their own work and also helping out policymakers and insurers who are trying to figure out how they'll pay for stem cell therapies in the future.”
The Times quoted the California Stem Cell Report as saying last week,
 “The Alpha clinics are aimed at creation of a sturdy foundation for the stem cell industry in California, capitalizing on the burgeoning, international lure of stem cell treatments.”
The proposal envisions Alpha stem cell clinics at major, established institutions around the state. It is possible that two could be located in the Los Angeles area at institutions such as UCLA, USC, Cedars-Sinai or the City of Hope, all of which have representatives on the stem cell agency's governing board. Other likely locations are in the San Francisco Bay area and San Diego, again at facilities such as Stanford, UC San Francisco and UC San Diego that have representation on the agency board.

Institutions competing for the grants, including businesses, will be subject to closed-door. peer review prior to final action by the full governing board.  

UCLA Researcher Calls for Easing of Restrictions on Stem Cell Lines Derived from Eggs From Paid Providers

A UCLA researcher has spoken out in support of a proposal to allow use of California stem cell agency funds to purchase stem cell lines derived from eggs provided by women who have been paid for the service.

Kathrin Plath, an associate professor, said in a letter to the agency that she and her colleagues would like to use a line from the Oregon SCNT experiment by Shoukhrat Mitalipov in which human stem cells were cloned. Currently agency funds cannot be used for that purpose as a result of regulations that are the extension of a state law that bars use of agency funds for payment for eggs.

The agency's standards group meets later today to consider changing those regulations. The proposal will then go before the full board tomorrow.

Plath, who has received $5 million from CIRM, said,
“In my lab, we are ... interested in understanding what happens to the somatically silenced X chromosome when differentiated cells are reprogrammed by SCNT. The key question is: are these SCNT-ESCs more similar to iPSCs or fertilization-derived ESCs with respect to the epigenetic state of the X chromosome. Furthermore, it has been shown in mouse reprogramming that the active X chromosome becomes deregulated during SCNT-based reprogramming, and we would like to address this problem in the human system as well.
“We believe that the comparison of the epigenetic states between fertilization-derived ESCs, SCNT-ESCs and human iPSCs is important for a better characterization of these cells and understanding of their epigenetic nature.”

Co-vice Chairman of California Stem Cell Agency Remains in Critical Condition

Duane Roth, the co-vice chairman of the California stem cell agency, remains in critical condition with brain injuries following a weekend bicycle accident.

According to a report by Bradley Fikes in the San Diego U-T, Roth's family is preparing for a recovery that will take weeks. Roth is currently in a medically induced coma.

Roth's wife, Renee, released a statement through the UC San Diego Medical Center that said,
“His condition is currently listed as critical. Duane is in the great hands of the university’s doctors and nurses and we are very happy with the outstanding care he is receiving. We do ask that our privacy be respected as Duane heals. We will be in touch to share more.”
The accident occurred Sunday in the mountains east of San Diego when Roth hit a rocky embankment or outcropping and his helmet split open on the impact.

Roth is CEO of Connect, a technology business group. He has served on the stem cell agency board since 2006.

(An earlier version of this item incorrectly described Roth as CEO of Current instead of Connect.)

Tuesday, July 23, 2013

Correct Link to CIRM Report on Business Aspects of Alpha Clinics

The "Inside Alpha Clinics' Business" item yesterday had a bad link to the CIRM report on the proposal. Here is the correct link.  A thank you to Kevin McCormack of CIRM for pointing this out.

How to Stay On Top of California's Stem Cell Research Cash Cow -- At Least This Week

Persons interested in listening to Thursday's hearing on California's $70 million “Alpha” stem clinic proposal can do so by two different methods via the Internet.

In addition to Internet access, the public can participate in the meeting in Burlingame, Ca., and also at two teleconference locations in Los Angeles. The Internet access does not allow two-way participation.

If you have money in the game, our advice is to attend the meeting in Burlingame. Only a handful of business people and scientists attend the agency's governing board meetings, but they seem to benefit from the information and discussion as well as from the ability to meet face-to-face with CIRM officials and board members.

Of particular interest may be a scheduled discussion of CIRM's goals and direction this year and next along with other proposals that will funnel $128 million to researchers in California, including the clinic plan.

If stem cell agency fans do not have time to sit through the day-long proceedings, they can follow developments via the California Stem Cell Report, which will be covering the meeting live via the Internet and filing stories as warranted.

Instructions for Internet access can be found on the meeting agenda. One method is a relatively straightforward audiocast. The other involves WebEx, which may involve some configuration of your computer. However, the method also shows the Power Point presentations that are used during the meeting and are otherwise not available in advance or on the day of the meeting. They often contain valuable information that informs the discussions of the board of the $3 billion agency.

In either case, you will want to check out the procedures in advance if you have not used them before. The dial-in number for the audiocast is 866-320-4708 with the password of 297273. Here is the link for the WebEx connection: https://cirm.webex.com/cirm/onstage/g.php?d=286602980&t=a&EA=acheung%40c...

As for the teleconference locations, the specific addresses are on the agenda. But you should ask in advance for more information on the Cedars-Sinai location to be sure you can find it on the day of the meeting. The Cedars complex is very large.

Tomorrow the agency's standards group will take up a proposal to allow CIRM grant recipients to purchasestem cell lines derived from eggs from paid donors. Unfortunately, that session is not available either by Internet or teleconference, but only in San Francisco. The proposal is expected to move forward to the full board on Thursday but it could be modified.

Monday, July 22, 2013

Co-vice Chairman of California Stem Cell Agency Hospitalized with Brain Injury

Duane Roth
Connect Photo
Duane Roth, co-vice chairman of the $3 billion California stem cell agency, has been hospitalized in a medically induced coma following a bicycle accident yesterday in the mountains east of San Diego.

Roth hit a rock embankment and broke his helmet, according to news reports. He was flown to the UC San Diego Medical Center, where he underwent surgery to remove a piece of his skull to relieve pressure on his brain, according to an account by Bruce Bigelow on Xconomy.

Bradley Fikes of the San Diego U-T reported that Roth is expected to kept in a coma for at least several days until his condition improves. 

J.T. Thomas, chairman of the stem cell agency, said in a statement,
“Our thoughts, prayers and best wishes for a full recovery are with Duane and his family.”
Roth, CEO of Connect, an organization that supports the technology industry, has served on the governing board of the $3 billion California stem cell agency since 2006. He has been a strong voice for business at the agency and likely would have been active participant in board discussion this Thursday of one of the agency's major initiatives that will benefit business – a $70 million stem cell clinic plan.

Inside the Business in California's $70 Million Alpha Stem Cell Clinic Proposal

Want to know more about the business aspects of a $70 million proposal to create a chain of “Alpha” stem cell clinics in California?

More details can be found in a report from the California stem cell agency titled “Alpha Stem Cell Clinics: Delivering a New Kind of Medicine.”

Among other things, the 23-page report discusses how the plan would guide efforts to build profits into stem cell therapies and to develop strategies to attract investors and philanthropists. Not all of the business questions are answered. However, the report does paint a more complete picture of how the clinics would lead to actual production and marketing of a therapy. Overall, the proposal is aimed at creating a sturdy foundation for the stem cell industry in California, one that surpasses anything found elsewhere in the world.

The stem cell agency's governing board is set to move forward on the Alpha clinics at its meeting on Thursday. This week's action involves approval of the concept with an RFA coming in October. Awards to six recipients could be made as early as July of next year.

The business aspects of the proposal are critical because without a clear pathway to profits no stem cell therapies will be available on anything approaching a significant scale. 

CIRM President Alan Trounson first advanced the Alpha concept two years ago. Last fall the $3 billion agency brought together 70 folks from the stem cell world to ponder the idea and to make suggestions. CIRM's report on the discussions at the workshop served as the basis for the proposal to be considered by its governing board this week. Here are excerpts from the report.
“Workshop participants...emphasized the need for engaged experts who can consider and implement strategies for reimbursement (i.e.generating profits) for stem cell therapies, and to gather evidence for their value and effectiveness that will be important for coverage by payers. Having clear pathways in place will help in building financially sustainable clinics as stem cell therapies gain approval and are implemented as standard medical practice. The Alpha Coordinating Center (funded at $15 million) would work with Accountable Care Organizations (funding gouprs that tie performance to payment) and multi-stakeholder collaborations to generate evidence for informing coverage and payment policies.”
“Incentivizing company sponsors of clinical trials to participate in data sharing will be challenging, and it will be important to protect their interests as appropriate, by respecting confidentiality of proprietary information, while at the same time requiring an appropriate degree of data sharing to advance the mission of the Alpha Stem Cell Clinics Network(five clinics funded at $11 million each). It is interesting to note that at this time, the landscape of disclosing clinical trial results is in flux, and there is increasing international pressure for companies to disclose information on safety and efficacy to the research and medical communities.”

“Alpha Stem Cell Clinics will create unique models for assessing the financial viability of stem cell therapies in a clinical setting. Cost and revenue data may serve as the basis for developing reimbursement options among the public and private sector as therapies accumulate. Identification of reimbursement options can reduce investor uncertainties and encourage further investment by pharmaceutical companies, investors, funding agencies and philanthropists.
“The elements of the Alpha Stem Cell Clinics Network, namely the clinical sites and central coordinating center, will interact with external entities to generate revenue streams that would ultimately ensure financial sustainability independent of CIRM funding (Figure 3).”

“The Coordinating and Information Management Center could develop a fee for service model for its consulting services, and operate like a CRO. Sponsors could choose whether to use the consulting services and whether to use the Alpha Stem Cell Clinics Sites. The Alpha Stem Cell Clinics Sites would generate operating revenue by running the clinical trials and could perhaps support the Center with revenues, as the volume of trials grows and the Network builds steam.

“In a second model, clinical trial sponsors would all contract with the Coordinating and Information Management Center, which would then set prices according to services needed. From this revenue, the Center would pay the Alpha Stem Cell Clinics Sites for costs associated with the clinical trials.
“By the time the CIRM seed money is depleted, the clinics should have established a strong track record and brand for excellence in conducting clinical trials in stem cell therapies, which would attract more clinical trial sponsors, including companies. To have the largest possible impact on healthcare, it will be desirable to increase industry involvement for cell therapies. However engaging corporate involvement could be challenging, given that many cell therapies are not considered patentable, and many of the ongoing trials are conducted in academic settings. It was suggested that the Alpha Stem Cell Clinics Network align as much as possible with corporate “mentality” to maximize corporate participation.

“Overall, the Alpha Stem Cell Clinics Network will help companies increase their 'bandwidth' and run stem cell therapy clinical trials more effectively and successfully. Many companies will already have sufficient in-house expertise for administration and regulatory guidance, and may not need to engage the Center’s consulting services. They would be attracted to the Alpha Stem Cell Clinics Network because of advantages for clinical trials such as benefiting from the collective databases, know-how and experience of the 'brain trust,' positive interactions and lines of communication with the FDA and regulatory experts, positive branding, quality control, accreditation for their trials, access to patient registries for outreach and patient recruitment and, through its clinical trial management resources, help with enrollment.
“Workshop participants also emphasized that attaining reimbursement for stem cell therapies will be necessary for delivering approved therapies into medical practice. It is likely that the business models for at least some of the clinics will resemble bone marrow/HSC transplant clinics, where for stem cell therapies that are proven superior to the standard of care, the clinic will directly receive reimbursement from insurers for the procedure and follow-up care.

“Reaching this point will require advance advocacy and preparation, and the engagement with the CMS at an early stage of product development. It was recommended that the Alpha Stem Cell Clinics Coordinating and Information Management Center should employ experts in reimbursement methodologies to facilitate entry of approved products into healthcare delivery. One workshop participant, Jeff Sheehy(a stem cell agency board member), suggested that early engagement with Accountable Care Organizations (ACOs) could be helpful, given that stem cell therapies offer the promise of cures, which in the long run will offer high value and effectiveness, albeit with ' high front end costs and the necessity of developing the appropriate infrastructure for delivering complex cell based procedures.' Consortiums such as the Green Park Collaborative are being established to develop methodological standards to demonstrate the effectiveness and value of new technologies. These data could be used to inform healthcare payers of the overall benefits of cell therapies and their long-term value, as compared with existing therapies."
“In 2016 and beyond, CIRM will initiate the 'Delivery' phase, in which priorities will be 'facilitating commercialization (and non-commercial adoption, where appropriate) of therapies, advancing therapies to patients, and enabling business models for stem cell-based therapies.' Connecting this network to other networks and centers with a similar mission outside of California will further accelerate the development and delivery of stem cell therapies, through the global exchange of information and expertise. International testing of experimental therapies developed in California will be essential for ensuring their sustainability, as regulatory approval and widespread delivery of these products in major markets throughout the world will ensure commercial viability and sustainability of companies and universities that produce them, which will in turn help deliver returns to investors. Ultimately, establishing a solid foundation for investor engagement will ensure the viability of stem cell therapies as they move into clinical practice.'”

Friday, July 19, 2013

Paying for Human Eggs, Ivan Illich and Jerry Brown

California's pay-for-eggs bill is stalled in a technical parliamentary process as opponents continue to wage their campaign urging Gov. Jerry Brown to veto the proposal, which swept easily through the legislature.

The latest volley against the industry-sponsored measure appeared this week as an op-ed in The Sacramento Bee. The legislation would allow women to be paid for eggs for scientific research. The op-ed piece invoked the philosopher Ivan Illich, a longtime friend of Jerry Brown and much respected by him.

The July 16 article was written by Diane Tober of the Center for Genetics and Society of Berkeley and Nancy Scheper-Hughes, a professor of medical anthropology at UC Berkeley and director of Organs Watch, a medical human rights documentation project.The piece said, 
“The late historian of science and technology, Ivan Illich, warned against the processes of medical industries which 'create new needs and control their satisfaction and turn human beings and their creativity into objects.'"
The op-ed said,
“Women's research eggs (have) become the hot new bio-product, increasing the profits of the multibillion-dollar-per-year infertility industry at the expense of women's health, safety and possibly, their future fertility. Is this the 'equity' we want for ourselves, our sisters and our daughters?”
In 2003, Brown wrote a remembrance of Illich, whom he first met in 1976. Brown said that Illich
“...bore witness to the destructive power of modern institutions that 'create needs faster than they can create satisfaction, and in the process of trying to meet the needs they generate, they consume the earth.'”
The egg compensation bill (AB926 by Assemblywoman Susan Bonilla, D-Concord) would remove a ban in California on paying women who provide their eggs for scientific research. Currently women who provide eggs for fertility purposes can be paid, sometimes as much as $50,000, depending on the characteristics of the woman providing the eggs. The bill would not alter the ban on using research funds from the California stem cell agency to pay for eggs. However, the agency next week will consider a proposal to allow use of agency funds to purchase stem cell lines derived from eggs through compensation. (For more information on the bill, see here, here and here.)

The egg bill received final legislative approval on July 1. The governor has 12 days to act on the measure once it actually reaches his desk. However, as of this morning, the legislation remained in what is known as the “engrossing and enrolling” process. It could be a routine delay but the process can also be used to manage the flow of legislation to the governor. Brown is currently on a two-week trip to Germany and Ireland and is not expected to return until near the first of August.

(An earlier version of this item incorrectly identified Nancy Scheper-Hughes as with the Center for Genetics and Society.)

Thursday, July 18, 2013

California Stem Cell Agency to Commit 20 Percent of Remaining Cash

The California stem cell agency next Thursday is expected to move forward with plans to give away $128 million, roughly 20 percent of its remaining funds.

The programs include the $70 million Alpha clinic plan, an ambitious five-year project that would be one of the $3 billion agency's hallmark efforts. The other “concept” rounds up next week include a $35 million “tools and technology”RFA and $23 million to recruit four more star, stem cell scientists to California.

The agency has committed about $1.8 billion of its $3 billion so far with about $700 million available for future spending. The remainder is going for the agency's administrative expenses. Cash for new grants is expected to run out sometime in 2017. Total cost of the agency's efforts run to about $6 billion because it operates with money borrowed by the state and must pay interest.

The agency is currently engaged in developing a plan to develop new sources of funding with an eye on some sort of public-private model. It solicited proposals in May for help with the effort, with the goal of completing a plan by this fall. At last report, however, the contract with the consultant had not been let.

The “strategic roadmap,” as it is called, is likely to come up at next week's governing board meeting along with a review of agency goals for the 2013-14 fiscal year.

On the agenda is a proposal to modify the agency's ban on use of its funds to purchase stem cell lines derived from human eggs supplied by women who have been paid. That proposal will also be heard by the agency's standards group next Wednesday.

The agency has additionally been busy implementing recommendations from a performance audit in May 2012. The audit said the agency was laboring under a range of problems that include protection of its intellectual property and management of its nearly 500 grants plus an inadequate ability to track its own performance. A staff Power Point presentation seems to indicate that it is making substantial progress in solving the problems identified by the audit.

Next week's meeting will be in Burlingame near the San Francisco Airport. Two remote locations where the public can participate are also available in Los Angeles. Addresses can be found on the agenda.

The California Stem Cell Report will provide live coverage of the meeting based on the Internet audiocast with stories filed as warranted.  

Wednesday, July 17, 2013

California's $70 Million 'Alpha' Stem Cell Clinic Plan Headed for Approval Next Week

Alpha clinic organizational diagram
Graphic by CIRM
California's stem cell agency next week is likely to approve a $70 million plan to build a taxpayer-financed chain of  “Alpha” stem cell clinics in what could be a major step towards making California the stem cell capital of the world,

The proposal would create five centers at existing institutions or businesses to be funded at up to $11 million each over five years. Also proposed is a coordination and information center that would receive $15 million over five years.

A story in Nature Medicine said that the Alpha clinics would be the first-ever “clinical trials network focused around a broad therapeutic platform.”

The clinics are expected to draw stem cell projects from the around the world as well as those funded by the $3 billion California stem cell agency. The proposal would be one of the largest single research efforts funded by the agency, formally known as the California Institute for Regenerative Medicine (CIRM) and use about 10 percent of its remaining cash.

The Alpha clinics are aimed at creation of a sturdy foundation for the stem cell industry in California, capitalizing on the burgeoning, international lure of stem cell treatments. Indeed, one of the objectives of the information center is to divert people from dubious treatments elsewhere.

The plan would fill a “profound gap” in quality information about stem cell treatments, according to a CIRM document, which said,
“By providing this resource, the public and potential patients would be better educated and informed, whether or not they should opt to enroll in clinical trials or approved treatments at any of the Alpha clinics.”
The Alpha concept was first broached two years ago publicly by CIRM President Alan Trounson, a pioneer in IVF research and the IVF business. His proposal has received early and heavy attention on the CIRM website with a video, blog items and a white paper.

The plan has received little critical attention although a researcher from an institution that could be a candidate for an Alpha clinic commented harshly in May on the California Stem Cell Report, calling the proposal “an irresponsible waste”and a “boondoggle for some medical schools.” The researcher, who asked that he/she not be identified, said,
“CIRM will pay for an unneeded infrastructure that will be empty space and staff sitting on their hands 99 percent of the time.  Or worse yet, CIRM will pay but the space will be used for other things, other clinic procedures paid for by insurance.”  
Elie Dolgin's July 8 piece in Nature Medicine quoted Mahendra Rao, director of the Center for Regenerative Medicine at the US National Institutes of Health (NIH), as applauding the concept. However, Rao said he doesn't anticipate the approach being tried nationally soon.

Dolgin wrote,
“Rao regularly asks researchers hoping to advance promising stem cell therapies whether they require additional clinical infrastructure. 'So far, what they've told us is they'll let us know if they need anything more than (the) programs that we have already established,' he says.”
The question of the size of the demand for Alpha clinics is not addressed in the CIRM concept plan. Also absent is much discussion of the business aspects of the proposal. It does mention “corporate sponsors” in passing. In a CIRM blog item yesterday, Natalie DeWitt, special project director at the agency, touched on business elements, declaring,
“(The proprosal) will yield better clinical trial design, accelerated approval of high quality treatments, and data and know-how to inform regulatory and reimbursement decisions.”
Reimbursement is the industry euphemism for creating ways to generate profits for stem cell firms.

The proposal said applicants would have to bring substantial support from their own institutions and “demonstrate the potential to bring in a pipeline of additional stem cell-based therapeutic trials as well as future funding streams to sustain the clinic.” Applicants would also be “evaluated in their ability to create a positive 'brand' that would attract clinical trials.”

Also up in the air was whether grant reviewers, all of whom come from out-of-state, would have special expertise to evaluate the business aspects of each applicant's proposal along with their business track record.

What is before the CIRM directors July 25 at their meeting in Burlingame, Ca., is a request for approval of the concept, which would be fleshed out for the RFA. The governing board almost always approves staff concepts, although they may modify them slightly. A number of directors come from institutions that are likely to be applicants in the program. They can participate in voting on the concept plan but would be barred from voting on any applications that come in later. The two RFAs could go out as early as October with approval of funding of applications one year from now.

In addition to the Burlingame meeting site, members of the public can participate from two teleconference locations in the Los Angeles area. The specific locations can be found on the meeting agenda.

The California Stem Cell Report will provide live coverage of the entire meeting, filing reports as warranted based on the Internet audiocast.

Here are excerpts from CIRM's staff document on the plan.
“To accelerate therapeutic development and delivery of stem cell therapies, CIRM proposes establishing the CIRM Alpha Stem Cell Clinics Network (CASC Network). The network will be designed to support projects emanating from CIRM’s funding pipeline, as well as scientifically outstanding stem cell products being developed worldwide and brought to California. Conceptually, the CASC Network is intended to be a sustainable infrastructure designed to support academic- and industry-initiated clinical trials, and delivery of therapies proven safe and effective.”

“The major thrusts (of the overall plan) will be:
• Development of clinical capacity and associated resources designed to support the effective implementation and execution of clinical trials and delivery of registered stem cell therapies
• Compilation of data and information concerning clinical trial experience and therapy outcomes to further inform the research, regulatory, and general community about the status of investigational stem cell interventions and long-term outcomes
• Dissemination of information to the public and counseling of patients and potential trial subjects about therapeutic options and clinical trials involving stem cells in the network and elsewhere.”
“The long-term vision is for the Alpha Clinics to expand and accommodate a broad array of stem cell-based clinical trials, where the trial meets the scientific, clinical trial design and ethical standards set forth by the Alpha Clinics Network, as well as FDA approved treatments.”

The coordinating and information center would be expected to :
“Build relationships with Accountable Care Organizations, and participate in initiatives for informing coverage and payment decisions
“Design strategies to attract investors and philanthropists to CASC network
“Create business plans, and marketing and branding strategies for financial sustainability of the Alpha Clinics Sites and (the coordination/information center)”.

Friday, July 12, 2013

Shestack Resignation Letter: Heartfelt and Eloquent

Jon Shestack(l) with J.T. Thomas, chairman of
CIRM, at a 2012 board meeting
California Stem Cell Report photo
Patient advocate Jon Shestack , who resigned this week as a director of the California stem cell agency, was on board on Day One in December 2004 when the agency's work began with no offices, no desks, no chairs, no phones and no ability to even write checks.

Shestack's appointment came as a result of his work in the autism community. He and his wife, Portia Iversen, founded Cure Autism Now in 1995. A Hollywood film producer, Shestack rattled cages at CIRM from time to time during his eight years of service. And earlier this week, he wrote a heartfelt, eloquent resignation letter, which he provided to the California Stem Cell Report. The full text can be found below. Here are some excerpts.
“Over eight years there were moments that were inspiring, some were contentious, and there was a bruising number of meetings but through it all, the board was involved, passionate and, will forever be for me, the gold standard when it comes to integrity.
“The same goes double for the staff – truly the most excellent, devoted, committed group of people I have ever had the pleasure of working with.”
“When I started at CIRM, my sweet son with autism was 12. Now he is 21. Over eight years our family has learned more about how many are the challenges that await him and how few the opportunities he has to look forward to. We have seen his world get smaller and smaller. While my son is special to me. He is not unique. There are thousands and thousands affected by mental illness who need a better life.
“Sometimes feel that I have failed these people, in particular those affected by autism or cerebral palsy. Though CIRM ran first-rate workshops on these disorders, we did not do all we could to follow up, put out disease-specific RFAs and get in proposals that addressed the workshop recommendations. I wish I had been more persuasive."
“In the movies, the third act is where the hero takes stock of all the previous wins and losses, all the hardships and lessons learned, and she puts all that knowledge together in new, and surprising ways until victory is within reach! As CIRM enters its third act, I hope it will do the same. I hope it will challenge itself, always put the urgency of the mission ahead of everything else and be willing to question the policies that have been so successful in the past, and consider that new ones may be needed for the future.
“And this is the future as I see it for CIRM. We will have faith, but we will continue to earn our miracles We will use our hearts and our minds to rip those miracles out of the dreamy future and make them real today. We will seek out the best scientists and encourage them to use all their wisdom, art and discernment to bring us cures. And when we have done that, we will do it again the next day. We will be optimistic, but not satisfied. We will question authority, despise complacency and above all love those among us in need of healing--this is the obligation without end, whose reward is also without end.”

TV News Piece on Pay-for-Eggs Airs in Los Angeles, San Francisco

The California pay-for-eggs legislation yesterday picked up some mainstream media coverage, including a two-minute, 24-second segment on two major television stations in Los Angeles and San Francisco.

The piece stands out because the mainstream media has largely ignored the bill, with a couple of exceptions. The piece is also exceptional because it appeared on TV news, which reaches many more people than print media.

Nannette Miranda, Sacramento bureau chief for KABC-TV in Los Angeles, KGTV in San Diego, KGO-TV in San Francisco and KFSN-TV in Fresno, prepared the segment, which included on-camera interviews with both supporters and opponents. The video appeared on KGO and KABC and may well appear later on the other stations. It can be seen at the end of this item.

The legislation, AB926 by Susan Bonilla, D-Concord, would remove the ban in California on paying women for their eggs for stem cell and other scientific research. Women can already be paid for their eggs for fertility purposes.

Another piece on the bill appeared in another mainstream media outlet this morning, the San Diego U-T. Writing in an op-ed column, Leah Campbell said she sold her eggs at age 25 and has since become infertile as the result of problems her doctors believe involved the process of providing the eggs.
“Six months (after providing the eggs) my body began to fail me. I had always been a healthy and active woman, but suddenly I was crippled by pain and unable to live the life I had once enjoyed. I was soon diagnosed with stage IV endometriosis, a disease my doctors now believe was pushed into overdrive as a result of the potent hormones involved in my egg donation protocols.”
Campbell continued,
“AB 926 may open the doors for increased fertility research, but the potential costs for women’s lives and health far outweigh any compensation that could ever be offered.”

Sacramento Mental Health Advocate Appointed to Stem Cell Agency Board

Al Rowlett
Turning Point photo
Sacramento mental health advocate Al Rowlett has been named to the governing board of the $3 billion California stem cell agency, it was announced today.

Rowlett replaces Jonathan Shestack on the 29-member panel. Shestack had served on the board since 2004, when the agency was created by the Proposition 71 ballot initiative.

Rowlett is chief operating officer of Turning Point Community Programs in Sacramento. He was appointed to the CIRM board by California Assembly Speaker John Perez, D-Los Angeles. Rowlett will fill one of the 10 patient advocate slots on the board. He will be only African-American on the panel. The board had also included one African-American, Ted Love, from 2004 to April 2012, when Love resigned.

Rowlett is no stranger to public and governmental service. He is in his second term as a member of the Elk Grove school board, the fifth largest school district in California. He has worked for Turning Point since 1981.

CIRM's press release said Rowlett also serves on several other boards including Child Abuse Prevention Center, California Institute of Mental Health and is a commissioner for the United States Psychiatric Rehabilitation Association Certification Program. In 2007, Rowlett won the National Association of Social Work- California and California State University – Heart of Social Work Award and the Asian Pacific Community Counseling – Inspirational Mental Health Leadership Award.

Veto Campaign Launched on California Pay-For-Eggs Bill

Opponents of the California pay-for-eggs bill have kicked off a campaign to urge Gov. Jerry Brown to veto the industry-backed legislation.

The Center for Genetics and Society of Berkeley yesterday posted a pitch on its website urging readers to contact the governor's office by email, fax, phone or letter. The target is a bill that would remove the ban in California on paying women for their eggs for stem cell and other scientific research. Women can already be paid for their eggs for fertility purposes.

Diane Tober, associate executive director of the center, wrote,
“If you agree that more research on short- and long-term risks is needed before expanding the market for women’s eggs, please act quickly. Contact Governor Brown and ask him to veto AB926.”
Also making the same pitch is the Alliance for Humane Biology, another San Francisco Bay area organization.

The bill, AB926 by Assemblywoman Susan Bonilla, D-Concord, has literally been cloaked in motherhood/reproductive issues. The measure has easily swept through the legislature and is now on its way to the governor. The bill is sponsored by the AssociationFew if any stem cell or other research organizations have been heard from during hearings on the bill. (For more information, see here, here and here.)

However, stem cell scientists have complained in past years about the lack of eggs for research, declaring that women want to be paid.

The measure would not affect the ban on compensation for eggs in research funded by the $3 billion California stem cell agency. However, the agency on July 24 will consider providing exceptions for stem cell lines derived from eggs that involve compensation for women.

Thursday, July 11, 2013

"Comfort News" for California's Stem Cell Research Effort

The California stem cell agency has enjoyed a spate of good financial and scientific news this week from the biotech industry as the research effort pushes on with its mission of turning stem cells into cures.

The $3 billion agency is scheduled to make its last grants in less than three years and, given the glacial pace of medical research, needs all the help it can get by then to bring a stem cell therapy close to the marketplace – the promise it made to voters when the agency was created nine years ago.

CIRM, as the agency is known, requires not only steady scientific progress but also a rosy outlook for the industry, which has languished in past years as major investors shunned the field. This week, CIRM garnered good news on both fronts.

There was enough so that the agency even touted it on the agency's research blog in an item by Neil Littman, CIRM's business development officer. He said it all helps to leverage CIRM investments and create a favorable investment climate. The good news included yesterday's announcement that Viacyte, Inc., of San Diego, Ca., has come up with $10.6 million needed to match a $10.1 million, much-ballyhooed award from CIRM last fall. The Viacyte financing includes important support from Big Pharma, in the form of Johnson & Johnson. CIRM has pumped a total of $39.4 million into Viacyte.

Another CIRM award winner, Cellular Dynamics International, Inc., of Madison, Wisc., yesterday announced its price on its upcoming stock offering to raise up to $53 million. Cellular Dynamics scored $16 million from the agency last March.

The “comfort news” for CIRM also included Monday's announcement that Capricor, Inc., a private Beverly Hills company benefiting from $27 million from the California stem cell agency, is merging with publicly traded Niles Therapeutic, Inc., of San Mateo. The merger is aimed at providing better access to capital.
And then there was Tuesday's news that a $20 million CIRM disease team award is paying off with the beginning of a clinical trial by Calimmune of Tucson, Az. for an HIV treatment.

All on top of the news in June when bluebird bio of Masschusetts brought in $101 million on its stock offering. Bluebird is the recipient of a $9.4 million CIRM award.

The rosy news comes amid a generally better outlook for biotech in general. John Carroll, editor of Fierce Biotech, this week noted that there were only 11 biotech stock offerings last year. He wrote,
“In the last 6 months, though, the industry has seen a tremendous rebound, with almost twice that number of IPOs in half the time. And there's no sign that the great leap into the public market is waning, with 10 more IPOs in the queue.”
Carroll's comments were echoed in a piece by Peter Winter on Bioworld headlined “Bubbleology and Biotech's Bull Run.”

All of this plays into what some might call the “everybody's-doing-it dance" or the “lemming syndrome,” depending on your point of view. The reality is that big investors and venture capitalists are timid souls and need the comfort of companionship-in-risk as they fork over tens or hundreds of millions of dollars on something that may not pay off for a decade or more. No one wants to be the out-front pioneer who winds up with financial arrows in his or her back. Being in a crowd provides an illusion of safety.

Of course, there is always the caveat about how markets and investors are fickle. A piece of bad news can translate quickly into major reversals as Apple has learned over the last year. Nonetheless, the folks at the stem cell agency have to  be feeling good today.

Wednesday, July 10, 2013

Pay-for-Eggs Legislation: Strange Bedfellows and Existential Questions

 The California pay-for-eggs bill today generated a feature article that said the legislation has “sparked an unusual lineup of partisans on both sides and resonates far beyond” the Golden State.

The piece by Alex Mathews on Capitol Weekly, a news service specializing in California government and political coverage, said,
“(C)omplicating the issue is California’s role as a national leader in stem cell research, the existential question of who or what constitutes a research subject, and finally, the fact that compensation for fertility purposes is and has been legal for years in California.”
Mathews was writing about the measure (AB926) by Assemblywoman Susan Bonilla, D-Concord, that removes a ban in California on paying women for eggs for scientific research. Currently women can be paid in California for providing eggs for IVF. The measure would not alter a ban on compensation for eggs in research financed by the $3 billion California stem cell agency. However, later this month, the agency will consider modifying its position somewhat.

The bill has passed the legislature and is on its way to Gov. Jerry Brown. The industry association sponsoring the bill expects the governor to sign it later this month although the governor, as a general rule, does not make public commitments on legislation.

Mathews' article covered the background and arguments on the bill and noted that it has received little mainstream media attention.

Lisa Ikemoto
UC Davis photo
She also quoted Lisa Ikemoto, a law professor and bioethicist at UC Davis, on the sensitive nature of the issue. Ikemoto said,
“On the fertility side, it’s politically hard to touch because it’s all around family formation. Nobody wants to restrict family formation. On the research side, when the issue of payment for eggs came up, it was connected with human embryonic stem cell research, and human embryonic stem cell research was politicized from the outset.”
Mathews also wrote about the strange bedfellows opposing the bill. She said,

“Groups that fundamentally oppose stem cell research such as the California Catholic Conference and other pro-life groups are natural opponents of the bill, but they are joined by a number of pro-choice groups who expressed concerns over the limited research on the effects of egg donation on women’s health.”

California Stem Cell Merger: Capricor and Niles Therapeutics

Capricor, Inc., a Beverly Hills company benefiting from $27 million from the California stem cell agency, this week announced that it is merging with Niles Therapeutic, Inc., of San Mateo.

Linda Marban
Capricor photo
The Capricor story and its treatment for heart disease have been highlighted (see here and here) by the $3 billion state research agency, which is partially funding a clinical trial for the firm. The firm sprang from work by Eduardo Marban of Cedars-Sinai in Los Angeles, one of Capricor's founders. He received $6.9 million for his early and current work. Capricor was awarded $19.8 million more.

Capricor, a privately held firm, and the publicly traded Niles announced on Monday that they were merging. The new company will be known as Capricor Therapeutics, Inc., and will be based in San Mateo.
The new firm will be publicly traded with Capricor CEO Linda Marban as the new CEO.

The new board of directors will have two members from Niles and seven from Capricor, including its executive chairman, Frank Litvack, who was an unsuccessful candidate for chairman of the stem cell agency board in 2011.

The merger press release said that the new company “should have better access to capital, more potential for steady pipeline development and more risk diversification."

On completion of the merger, a joint press release said,
Nile will issue to Capricor stockholders shares of Nile common stock such that Capricor stockholders will own approximately 90% of the combined company's outstanding shares, and Nile stockholders will own approximately 10%, calculated in each case on a fully-diluted basis assuming the issuance of shares underlying options and warrants. Options of Capricor will be assumed by Nile and become options to acquire stock of Nile.”
Linda Marban said,
"Capricor's and Nile's product portfolios complement each other well, as our therapies will address both the underlying causes and debilitating effects of heart disease. Capricor's CDCs are allogeneic cardiac derived stem cells that aim to attenuate and potentially improve damage to the heart that can result in heart failure, while Nile's cenderitide is intended to treat patients following hospital discharge from an acute episode of heart failure."
Niles' stock price stood at $0.04 recently. Its 52 week high was $0.20 and the 52-week low was $0.02.

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