Scottsdale, Arizona (PRWEB) April 21, 2012

QualityStocks would like to highlight Advanced Cell Technology, Inc., a publicly traded biotechnology company applying cellular technology in the field of regenerative medicine. ACT specializes in the development of cellular therapies for the treatment of diseases and conditions that impact tens of millions of people worldwide. The company applies stem cell-based technologies (both adult and human embryonic) and other proprietary methods in the field of regenerative medicine to bring patient-specific therapies from the lab bench to the bedside.

In the companys news yesterday,

Advanced Cell Technology reported the successful completion of the dosing of the third patient in its phase I/II trial for dry age-related macular degeneration (AMD) using retinal pigment epithelial (RPE) cells from human embryonic stem cells (hESCs).

The company has already conducted the procedure in six other patients at UCLA, and said it anticipates adding more sites in the near future. Gary Rabin, chairman and CEO of ACT, also noted the prestige of individuals participating in the trials.

The completion of enrollment of the first cohort of patients in our dry AMD clinical trial is a significant step forward in our RPE clinical program. The first six patients in the U.S. trials have all been treated at UCLA, and as we have recently announced, the trials should soon expand to additional sites, Rabin stated in the press release. As we have built our clinical team, we have been fortunate to have attracted the attention of some of the highest-caliber ophthalmologists and related institutions in the U.S. and Europe and recognize the huge value that their expertise provides us as we plan for the future of our therapeutic programs. With their guidance, we have also worked with the FDA to successfully expand the criteria of eligibility for patients to participate in our dry AMD trial.

The procedures at UCLA were all conducted by the team led by Steven Schwartz, M.D., Ahmanson, professor of ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLAs Jules Stein Eye Institute.

Dr. Schwartz reports that there have been no complications with any of the procedures, nor have there been any safety issues.

ACT currently is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells as treatment for various forms of macular degeneration.

We are extremely pleased with the progress being made in all three of our clinical trials here in the U.S. and the UK, stated Robert Lanza, M.D., ACTs chief scientific officer. The data we are reviewing seems to be pointing in the appropriate direction. We still have many patients left to treat during the course of these trials, but our team remains hopeful that stem cell-derived RPE cells may someday provide a new therapeutic approach for the treatment of many forms of macular degeneration. We hear from patients who suffer from these diseases on nearly a daily basis, and appreciate the huge responsibility we have to them.

Link:
QualityStocks News - Advance Cell Technology Completes Treatment of Third Dry AMD Patient in Phase I/II Clinical Trial

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of the third patient in its Phase I/II trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The outpatient transplantation surgery was performed successfully, and the patient is recovering uneventfully.

Gary Rabin, chairman and CEO of ACT, commented, The completion of enrollment of the first cohort of patients in our dry AMD clinical trial is a significant step forward in our RPE clinical program. The first six patients in the U.S. trials have all been treated at UCLA, and as we have recently announced, the trials should soon expand to additional sites. As we have built our clinical team, we have been fortunate to have attracted the attention of some of the highest-caliber ophthalmologists and related institutions in the U.S. and Europe and recognize the huge value that their expertise provides us as we plan for the future of our therapeutic programs. With their guidance, we have also worked with the FDA to successfully expand the criteria of eligibility for patients to participate in our dry AMD trial.

The procedures at UCLA were all conducted by the team led by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute.

The six patients treated at UCLA to date have tolerated the surgical procedure well. commented Dr. Schwartz. There have been no complications in the procedure, nor any issues relating to the safety of the injected stem cell-derived RPE cells in any of the patients. We continue to regularly evaluate all patients in the trial, and while still preliminary, I am encouraged by the patients progress and the relative straightforwardness of the surgical procedure.

We are extremely pleased with the progress being made in all three of our clinical trials here in the U.S. and the U.K., commented Robert Lanza, M.D., ACTs chief scientific officer. The data we are reviewing seems to be pointing in the appropriate direction, With the treatment of the latest two dry AMD patients, we look forward to having more significant points of reference to understand the progress of the trial and consider the endpoint design for the next phase. Both Stargardts disease and dry AMD are progressive diseases that result vision loss and blindness due to the thinning of the layer of RPE cells in the patient's macula, the central portion of the retina responsible for central vision. We still have many patients left to treat during the course of these trials, but our team remains hopeful that stem cell-derived RPE cells may someday provide a new therapeutic approach for the treatment of many forms of macular degeneration. We hear from patients who suffer from these diseases on nearly a daily basis, and appreciate the huge responsibility we have to them.

ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry-AMD or Stargardt's macular dystrophy (SMD) at 12 months, the studys primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Companys U.K. clinical trial was treated at Moorfields Eye Hospital in London. The final patient of the first cohort in the companys SMD trial in the U.S. was treated on February 13, 2012.

Further information about patient eligibility for the dry AMD study and the concurrent study on SMD is also available on http://www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 , NCT01469832 and NCT01344993.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

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ACT Announces Third Dry AMD Patient Treated in Clinical Trial

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The Cypress Times

CONTROVERSY CONTINUES OVER FOOD SAFETY AND GENETIC ENGINEERING The Cypress Times Those who support genetic engineering of animals and fish say it will increase the human food supply. But is it dangerous for people to ingest unnatural foods? Photo credit: News with Views/Paul Walter While most of the White House's focus is on ... and more »

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Indiana Public Media

Cook launches new Cook General BioTechnology division Zenopa Cook Group has announced the formation of Cook General BioTechnology, a new business unit that will support research into cell-based medical therapies. The division is being introduced following the group's acquisition of the assets of General ... Cook Group Forms Cook General BioTechnology, LLCMarketWatch (press release) Briefly Around the State + NationIndianapolis Star Medical-device maker Cook Group acquires Indianapolis cell, tissue processing ...The Republic all 19 news articles »

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Via Scoop.it – inPharmatics

Biopharmaceutical vendor AstraZeneca has launched a unified communications pilot using Microsoft Lync to improve collaboration among pharmaceutical sales reps, doctors and researchers.
Via mobile.eweek.com

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Michael West, CEO of Biotime, Inc.of Alameda, Ca., has published the text of his prepared remarks to the Institute of Medicine panel examining the performance of the $3 billion California stem cell agency.

Here is one excerpt from the statement by West, who was also CEO at Advanced Cell Technology and founded Geron.

"To put it simply, stem cell research by itself will not lead to cures. Research and DEVELOPMENT leads to cures. In my opinion, if CIRM fails to deliver on its goal to deliver cures, it will not be a result of internal governance issues. Instead, it will be a result of inefficient capital allocation. A graphic way of visualizing my point is to say that CIRM has historically funded primarily research, and little product development, i.e. large “R” little “d”. Approximately 5% of CIRM’s expenditures have been allocated to biotechnology and health science entities whose expertise is product development, and 95% has been allocated to nonprofit institutions in the state for basic research. Human therapeutic product development in the United States requires a very intense and expensive process for approval that is primarily focused on development side of the equation. In this respect, therapeutic approvals differ significantly from the discovery and development of silicon-based technologies that have been so successfully commercialized in California."

Here is a link to the full text of what West posted on the Biotime web site.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

A venture capitalist who said earlier this week that the California stem cell agency rejected 15 grant applications from Advanced Cell Technology this afternoon retracted the statement, which he said was incorrect.

Gregory Bonfiglio, managing partner in Proteus Regenerative Medicine, said in an email,

"Although I believed that number to be true at the time I stated it, I have now determined that the number of CIRM grant applications ACT filed as the principal investigator was substantially below 15."

Bonfiglio made the assertion Tuesday at a meeting of the Institute of Medicine panel looking into the performance of the $3 billion California stem cell agency, which has been criticized for its lack of funding of biotech firms.

Here is more of what Bonfiglio had to say in his email this afternoon,

"Unfortunately, your California Stem Cell Report posting on April 11 contains some inaccurate information, for which I appear to have been the source.  As you will recall, I stated during the IOM Panel that Advanced Cell Technology had submitted multiple applications for funding from CIRM, but had been unsuccessful in obtaining any funding from CIRM.  I also stated that ACT had been involved in “15 grant applications” to CIRM.   You highlighted that number in your April 11 California Stem Cell Report posting.   Unfortunately, that number is not accurate.  Although I believed that number to be true at the time I stated it, I have now determined that the number of CIRM grant applications ACT filed as the Principal Investigator was substantially below 15.   The number I quoted in the IOM Meeting on April 10 included applications in which ACT had some involvement, but was not the lead principal Investigator.  ACT has filed several applications for CIRM funding as the lead PI, but the number of CIRM applications in which ACT was the lead PI was far below 15.   Moreover, some of ACT’s direct applications for CIRM funding were withdrawn by ACT, rather than denied by CIRM.

"I would request that you correct this inaccuracy regarding ACT's applications for CIRM funding as soon as possible.  I'm sure you will agree that the regenerative medicine community, and the general public, have a real and significant interest in obtaining accurate information about developments at CIRM, and that the publication of inaccurate information is a tremendous disservice to all involved.  More importantly, ACT is a publicly traded company and the publication of inaccurate information regarding ACT, its technologies, or its funding could have adverse consequences for the company.   Furthermore, as an active participant in the regenerative medicine community who has spent his professional career developing a reputation for honesty, accuracy, and integrity I am very concerned that I might be the source of inaccurate information regarding developments within the field of regenerative medicine.  For these reasons, I would ask that you retract the statement in your April 11 Blog posting that ACT was 'rejected 15 times for funding' by CIRM, and that you refrain from making any other statements to that effect.

"I appreciate your cooperation in this regard, and I would request that you move quickly to correct the inaccuracy in your April 11 Blog posting.   As I am sure you are aware, information in blog postings is sometimes picked up by more traditional media, and I would not want any republication of this inaccurate information regarding ACT’s grant applications to CIRM."

At the time Bonfiglio made his comments concerning ACT, top officials of the stem cell agency were in the room, but did not make any statement concerning his assertion. On the morning of April 11 prior to publication of the item, the California Stem Cell Report asked ACT for comment .

No response has been received from ACT about the figure. CIRM also has not commented since the item appeared.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

IRVINE, Ca. – The $3 billion California stem cell agency was praised this week for making progress in accountability and transparency during the last year.

The comments came from a representative of California state Controlller John Chiang, the state's top fiscal officer and who also chairs the only state entity specifically charged with financial oversight of the stem cell agency and its board.

Ruth Holton-Hodson, deputy state controller, told the blue-ribbon Institute of Medicine panel examining the performance of the stem cell agency that the controller's office "would like to acknowledge the progress the new leadership has made in the last year towards making CIRM a far more transparent and accountable agency than it has been in the past."

CIRM has a new chairman, J.T. Thomas, a Los Angeles financier, who has been in place since the beginning of last July. He succeeded Bob Klein, who was the initial agency chairman and who took office in 2004.

In her testimony at the IOM hearing here on Tuesday, Holton-Hodson discussed previous problems that CIRM had with the transparency of its budget. She said,

"We are very pleased that CIRM’s new leadership recognized this as a problem and quickly adopted a much more transparent budget format which is broken down by function. To make CIRM’s expenditures as transparent as possible, we have also recommended that they post the annual budget on the website. Again, we’re pleased to say that the new leadership has agreed to do this."

She also said,

"At our most recent meeting (of the Citizens Financial Accountability and Oversight Committee), we also recommended that CIRM post all of its private donations and they have agreed to do this."

Holton-Hodson criticized the dual executive arrangement at CIRM that is written into law by Proposition 71. She said,

"It is difficult to uphold the appearance of accountability and objectivity when the board chair has direct line authority over some CIRM staff positions. In essence under the current model, the chair is responsible for evaluating and approving some of the work of the chair.

"While this issue is still outstanding, it is important to acknowledge that the current leadership has made significant progress in more clearly delineating the responsibilities of the chair and the president."

Here is the full text of Holton-Hodson's remarks.Statement from California state controller's office to IOM-CIRM panel April 10, 2012

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http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

(Editor's note: The assertion in this item that 15 applications by ACT were rejected by the California stem cell agency is incorrect, according to the venture capitalist who made the statement. He retracted it on the afternoon of April 12. His explanation can be found here. )


IRVINE, Ca. --The only firm in the nation conducting an ongoing hESC clinical trial has been rejected 15 times for funding by California's $3 billion stem cell agency.

The figure was reported yesterday at a hearing by the blue-ribbon Institute of Medicine panel looking into the performance of the stem cell agency, which has been sharply criticized in recent years for its paucity of industry funding.

Gregory Bonfiglio, managing partner in Proteus Regenerative Medicine, a stem cell venture capital firm in Portola Valley, Ca., disclosed the grant attempts by Advanced Cell Technology, whose nominal headquarters are in Santa Monica, Ca. Bonfiglio indicated that it was a high profile example of how CIRM is not taking the necessary steps to fulfill its goal of developing therapies that actually reach the clinic.

He noted that ACT received national attention in January when it posted favorable findings for its clinical trial at UCLA dealing with blindness but that the firm was still unable to win a CIRM grant over the last several years.

ACT had moved much of its operations to California in the wake of passage of Proposition 71, the measure that created the state's stem cell research effort in 2004. It has since re-centered its operations in Massachusetts.

The California Stem Cell Report has queried ACT on its grant efforts and will carry its response verbatim when it is received.

Another firm, which cannot be identified, said privately yesterday that it was rejected 14 times.

According to our calculations based on figures this morning on the CIRM web site, businesses have received only $54.3 million in grants and loans during the last seven years, 4 percent of the $1.3 billion awarded. However, the CIRM list slightly understates the industry total. At least two other firms are sharing in two $20 million grants involving academic institutions, but are not noted on the list.

Yesterday's IOM meeting was the second and final California public session for the CIRM inquiry. Most of the day was occupied by a variety of critiques of the organization. The panel has already heard extensively from the agency itself and beneficiaries of its grants. The IOM report is expected in November.

Harold Shapiro, chairman of the panel and former president of Princeton University, described yesterday afternoon's panel involving stem cell business executives as "one of the more interesting" of the day.

One of the speakers was Michael West, CEO of Biotime in Alameda, which has received $4.7 million from CIRM. West, the founder of Geron, was also head of ACT when it moved it to California. He said CIRM had several "blind spots," including misconceptions about how products are made. For example, West said, CIRM's performance indicates that it does not fully understand that development leads directly to cures -- not research.

West said that if the high tech industry had to rely on CIRM-type funding years ago, laptops and iPads would still be in the lab instead of the marketplace.

The business industry representatives said that creation of CIRM has been beneficial for stem cell  research, but cited a number of deficiencies in connection with industry applications.

In some ways, their comments echoed past remarks by several CIRM board members, who have expressed concern about the lack of funding for industry, as well as those of the agency's own external review panel. One issue raised by those CIRM directors has been the lack of grant reviewers with product development and industry expertise.

At yesterday's hearing, Gabriel Nistor, vice president of research and development at California Stem Cell in Irvine, said, it is "exceedingly rare to find academics (grant reviewers) that understand the complexities" involving industry. Nistor said his firm has applied for a "few" CIRM grants. None have been awarded.

Also speaking was Allan Robins, CEO of Viacyte in San Diego, who said his firm has done well with CIRM funding. It has received $26.2 million, nearly all of it in the form of a loan. But he said companies develop products – not academia.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

IRVINE, Ca. – The Center for Genetics and Society today said it would "wrong" to ask the people of California for more money to continue financing stem cell research at state expense.

Marcy Darnovsky, associate executive director of the Berkeley, Ca., non-profit group, addressed a blue-ribbon Institute of Medicine panel evaluating the performance of the $3 billion California stem cell agency, which is financed by money borrowed by the state. The agency is expected to run out of cash in about five years.

Darnovsky said,

"In structural terms, a key question now is what will happen after CIRM’s public funding is exhausted. According to CIRM’s transition plan, another bond measure for additional public funding 'would be premature at this time,' but is still on the table. In our view, any additional public monies for CIRM would have to be justified in an analysis that emphasized health care priorities and health care disparities. While there is always tension between the allocation of public funds to scientific research and to other public goods, given our state’s economic decline and budgetary crisis, with so many critical social programs being gutted, we believe it would be simply wrong to ask Californians to set aside more money for one avenue of research, however important."

Representatives of the stem cell agency were present at today's hearing on the UC Irvine campus, but did not speak publicly at today's session. CIRM officials, however, have testified before the panel on two other days of public hearings. The agency is paying the IOM $700,000 to conduct the study. Its results and recommendations are expected to be published in November.

Darnovsky and others testifying at the morning session were critical of the agency's lack of accountability, built-in conflicts of interest and immunity from normal government oversight (see here and here).

Darnovsky said, "

The requirement for 70% super-majorities (to change the law regarding CIRM) means that there is still no meaningful oversight of CIRM by elected officials. The ICOC is still tainted by its built-in conflicts of interest. It still includes no representation of the public beyond disease advocates. Members of CIRM’s powerful Working Groups, including the one that reviews grant applications, are still not required to publicly disclose their individual financial interests.

"Given that hundreds of millions of dollars remain to be disbursed, and the widely mooted possibility that CIRM will develop a role that continues beyond the public funding stream that was allocated in 2004, now is the time to clarify and address these issues."

Here is the full text of Darnovsky's comments.
Center for Genetics and Society statement to IOM-CIRM panel, April 10 2012

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IRVINE, Ca.-- California's unprecedented stem cell research effort faces a tight timetable for making major progress in fulfilling promises to voters seven years ago, complicated by potential conflicts of interest, a blue-ribbon panel was told this morning.

David Jensen, editor of the California Stem Cell Report, made the comments to the Institute of Medicine panel looking into the performance of the $3 billion California Institute of Regenerative Medicine.

The panel's inquiry comes as the agency is re-evaluating its strategies as it faces loss of funding in about 2017.

Here is the full text of Jensen's statement.
Statement to IOM-CIRM Panel by California Stem Cell Report April 9, 2012

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IRVINE, Ca. – The Consumer Watchdog organization says that serious consideration should be given to whether the state should halt borrowing money to finance the $3 billion California stem cell agency.

The statement was prepared for delivery tomorrow here to a blue-ribbon Institute of Medicine panel evaluating the performance of the research effort, which was created by a ballot initiative in 2004. The agency's only real source of cash is bonds issued by the state, which means the agency will cost $6 billion including interest by end of its grant-making life in about 2017.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said that the political and scientific environment has changed substantially since 2004. The Bush Administration had restricted federal funding of hESC research then, causing an uproar in the scientific community. Funding has since been restored.

Simpson said the stem cell measure "made sense" seven years ago. He said the stem cell agency and its governing board "must recognize that the political, scientific and economic environment have dramatically altered since the passage of Proposition 71."

His statement continued,

"It is also appropriate to consider seriously whether issuing all $3 billion in authorized bonds is the correct policy in light of the new environment and economic realties facing the state."

Simpson was invited make his statement to the IOM panel, which is midway through its public process of looking into CIRM's operations. It is doing so at the behest of CIRM, which is paying the prestigious organization $700,000 to perform the work.

Simpson also made a number of recommendations for changes at CIRM, many of which would require a change in state law or passage of another ballot measure. Proposition 71, which created CIRM and altered the state Constitution, requires a super, super-majority vote (70 percent) by the legislature to make changes at CIRM.

The Consumer Watchdog proposals (full text below) include reducing the size of the 29-member board to 15, including public members on the board, reducing the super-majority requirement on board quorums to a majority, eliminating the controversial dual executive arrangement at CIRM, conducting grant reviews in public and publicly disclosing the financial interests of reviewers.Consumer Watchdog Statement to IOM-CIRM Panel April 9, 2012

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Alltopics.com Offers Newest News Flashes about Biotechnology PR Web (press release) Alltopics.com has created a new section devoted to Biotechnology. The information, news and current articles are instantly available on Alltopics.com. Biotechnology.alltopics.com rates the issues by popularity. All the hot and current news, ... and more »

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By Ben Butkus

Stanford University researchers have published a method for using Fluidigm's digital PCR platform to conduct single-cell, real-time PCR to compare gene expression patterns of single cells.

The protocol is indicative of the increased use of Fluidigm's products for single-cell biology, an application area that the company has been heavily promoting over the past year.

In addition, the method may provide a powerful tool for understanding gene expression and differentiation in induced pluripotent stem cells and human embryonic stem cells for regenerative medicine, the researchers said.

In a paper published last week in Nature Protocols, researchers led by Joseph Wu, associate professor of medicine, cardiology, and radiology at Stanford University School of Medicine, described how they used Fluidigm's BioMark HD platform and Dynamic Array chips to analyze gene expression profiles of single iPSCs or hESCs approximately 11 hours after collection.

The team decided to publish the method after using it to conduct a study published last March in the Journal of Clinical Investigation that demonstrated how single-cell transcriptional profiling revealed heterogeneity in human iPSCs. "A lot of people asked us after that JCI paper how we exactly do this, so we decided to write a detailed protocol," Wu told PCR Insider.

Wu and colleagues began using Fluidigm's platform through the laboratory of fellow Stanford scientist Stephen Quake, a co-founder of the company and a co-author on the recent Nature Protocols paper.

According to Veronica Sanchez-Freire, a postdoc in Wu's lab and also a co-author on the paper, the group needed a tool to compare gene expression between individual cells in single colonies of iPSCs or hESCs with high sensitivity using a limiting amount of sample.

"We were interested in seeing how different gene expression could be in the cell depending on its position in the colony," Sanchez-Freire said. "We are looking at these iPS cells from different cell types and donors, and we always compare them to [human embryonic] stem cells, the gold standard but we also wanted to see how similar they are [to each other]."

Most traditional gene expression studies, using, for example, quantitative real-time PCR, extract RNA from a large population of cells for downstream expression analysis. "And we saw that when you do that, iPS cells and stem cells are very similar," Sanchez-Freire said. "But when you go to the single-cell level, we saw how the iPS cells are more heterogeneous than the ES cells."

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Stanford Group Publishes Fluidigm-Based Method for Gene Expression Profiling of Single Stem Cells

HOUSTON, April 12, 2012 /PRNewswire/ --Bellicum Pharmaceuticals, Inc. announced today the appointment of David M. Spencer, Ph.D. to Chief Scientific Officer. Dr. Spencer, a co-founder of Bellicum, joins the Company from Baylor College of Medicine where he was Vice Chairman of Pathology and Immunology.Dr. Spencer is the co-inventor of chemical induction of dimerization (CID), a technology used to control a wide range of biologic functions in cells, and applied in the Company's two lead product candidates.

(Photo: http://photos.prnewswire.com/prnh/20120412/NY85667 )

"We're pleased to have David join Bellicum and bring with him a singularly unique knowledge of the science behind our products," commented Tom Farrell, CEO of Bellicum Pharmaceuticals. "I look forward to his many contributions as we evaluate two new potentially breakthrough product candidates."

Dr. Spencer received The Michael E. DeBakey, M.D., Excellence in Research Award from Baylor College of Medicine in 2007 for his work developing a novel immune therapy-based approach to treating cancer, which relies on a small-molecule, CID, to improve dendritic cell function. In one iteration, Dr. Spencer's team used CID technology, which he co-invented, to create a much more potent vaccine against poorly immunogenic self-peptides. Dr. Spencer also developed a series of state-of-the-art, non-immunogenic suicide genes for gene therapy, which utilize endogenous caspase family proteases and CID technology. These inducible caspases are likely to become increasingly important as a safety switch for retrovirus-based gene therapy and cellular therapies, in general. This technology is the basis of two Bellicum clinical programs, including CaspaCIDe for the management of graft-versus-host disease (GVHD).

Phase 1 results from an ongoing clinical trial of CaspaCIDe were published in the New England Journal of Medicine in November of last year. The study reported that the "suicide gene" effectively caused the rapid and complete reversal of GVHD in acute leukemia patients who underwent stem cell transplant.

Dr. Spencer earned his Ph.D. from the Massachusetts Institute of Technology and completed his postdoctoral degree at Stanford University.

About Bellicum Pharmaceuticals

Bellicum Pharmaceuticals, Inc. is developing clinical applications of chemical induction of dimerization (CID), a drug-based remote control technology that extends the physician's reach beyond the point at which a treatment has been administered. Bellicum's mission is to leverage this smart technology to bring safe, effective, innovative cell therapies to market for patients with serious and life threatening diseases. The company's DeCIDe vaccines are designed to kill targeted cells by inducing a potent, durable, fully activated antigen-specific T cell immune response. Lead product BPX-101, an autologous DeCIDe vaccine, is in clinical development for patients with metastatic castrate resistant prostate cancer (mCRPC). CaspaCIDe is a cell therapy safety switch, permitting the rapid elimination of cells in the event of toxicity. CaspaCIDe DLI is a donor lymphocyte infusion administered following a hematopoietic stem cell transplant, in which the safety switch may be activated to resolve graft-versus-host disease (GVHD). For more information, visit http://www.bellicum.com

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Bellicum Appoints Baylor College of Medicine's David M. Spencer as Chief Scientific Officer

IRVINE, Calif.--(BUSINESS WIRE)--

California Stem Cell, Inc. (CSC)s Hans S. Keirstead, Ph.D. will speak at todays Global Emerging Leaders Forum in New York City, participating in a panel of the worlds leading innovators, philanthropists, and business thought-leaders who have gathered to discuss global issues. This symposium is the latest in a series of thought leadership and panel discussion appearances by CSC team members in recent months.

The NYC-based Global Emerging Leadership Forum was founded in 2011 to support emerging professionals through the discussion of the top social and economic issues of today, as well as emerging trends of the future. Dr. Keirstead will speak at 1pm in New York Citys Kaufmann Concert Hall, joining a diverse panel of influential and forward-thinking leaders in their respective fields. Attendees will gain valuable insight into the future of global society, global citizenship, corporate responsibility, and the politics of being an emerging global leader.

In February of this year, Dr. Keirstead presented at Singularity Universitys FutureMed event Exploring the Future of Healthcare. He delivered a presentation highlighting the powerful potential uses of stem cells for spinal cord injury and beyond. More recently, California Stem Cells Gabriel Nistor, M.D. participated in an Institute of Medicine (IOM) hosted review of the California Institute of Regenerative Medicine (CIRM)s programs, operations, strategies, and performance.

Details of California Stem Cell pubic speaking appearances are at: http://californiastemcell.com/press_cal

More information about the Global Emerging Leadership Forum: http://www.emergingleadersnyc.com/

More information about FutureMed: http://futuremed2020.com/

About California Stem Cell

California Stem Cell Inc. (CSC) is an Irvine, CA based company with proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes. CSC is able to supply its human cell populations to companies and institutions worldwide for use in the development of therapies, efficacy screening or the creation of toxicity profiles for candidate drugs, and experimental research tools.

CSC is currently focused on the development of stem cell based therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease), and metastatic cancers.

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California Stem Cell Chairman Hans Keirstead Speaks at Prominent Global Emerging Leadership Forum

AUSTIN - The Texas Medical Board Friday approved rules regulating adult stem cell therapy, concerned that the proliferation of the experimental treatment constitutes "an emergency state."

Despite opposition from some board members concerned that its action could wind up putting more patients in danger of harm from the unproven, unlicensed therapy, the board approved a policy that allows doctors to use it as long as they get the patient's consent and the approval of a review board that evaluates clinical research for safety. The therapy has been in the news since Gov. Rick Perry received it for an ailing back last year.

"We know this is far from a perfect policy, but our hope is that this affords people in Texas seeking this therapy some protection," said Dr. Irwin Zeitler, the board president. "The wheels of the federal government move so slowly - we're not willing to wait to protect our patients."

The board, which voted 10-4 to approve the regulations, promised it would work to improve them, pledging to bring revisions to its June meeting. No date has been set for when the policy approved Friday will take effect, but it will be at least 30 days, board staff said.

The policy, thought to be the first of its kind, has drawn criticism nationally and internationally for appearing to circumvent the Food and Drug Administration and for making the therapy commercially available before it has been proven safe and effective. The treatment is not approved by the FDA and patients typically must pay tens of thousands of dollars for it.

Adult stem cells, which multiply to replenish dying cells, have long been used to treat leukemia and other cancers, but in the last decade they have shown promise for tissue repair in many other diseases. Less versatile than embryonic stem cells, they are championed by many as a more ethical alternative because no embryo is destroyed.

But they are mostly in early-stage clinical trials and considered five to 10 years away from FDA approval.

The therapy gained national attention after it was revealed Perry received it last summer. Houston surgeon Stanley Jones injected the governor during his July 1 back surgery and intravenously in follow-up appointments.

todd.ackerman@chron.com

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Medical board approves controversial adult stem-cell rules

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