California Institute of Regenerative Medicine Issues Grants

The California Institute of Regenerative Medicine recently announced several grants to fund clinical stage research.  Importantly, CIRM has many different requirements than those offered under the Bayh-Dole Act.  The Press Release states:

South San Francisco, CA – The California Institute for Regenerative Medicine (CIRM), the world’s largest institution dedicated to regenerative medicine, today awarded $50.1 million to fund clinical-stage research projects aimed at advancing stem cell and gene therapy treatments for a variety conditions ranging from neurodegenerative diseases and blood cancers to HIV/AIDS.

The awards will support six projects in the Agency’s clinical program which provides funding for eligible stem cell and gene therapy-based projects through any stage of clinical trial activity.

The awards include: [Aspera Biomedicines, AcuraStem, Regenerative Path Technologies and the City of Hope].

Among the awards is a $12.4 million grant to support Regenerative Patch Technologies LLC in a Phase 2b clinical trial to evaluate the safety and efficacy of a retinal pigmented epithelial (RPE) implant. The implant will be evaluated in patients with geographic atrophy, a late-stage form of age-related macular degeneration (AMD), a common condition that can lead to vision loss in older adults.

The RPE is an important cell layer that supports the retina and plays a critical role in maintaining vision. In geographic atrophy, RPE cells break down over time, leading to impaired vision and a loss of independence.

The stem cell-based implant aims to promote the survival and function of the retina, protecting the eye from disease progression and potentially improving vision.

“This award supplies critical funding to support a Phase 2b clinical trial to achieve our goal of improving vision in patients with geographic atrophy”, said Jane Lebkowski, PhD, President of Regenerative Patch Technologies. “We want to thank CIRM for their support of this program.”

Geographic atrophy affects more than 8 million people worldwide and an estimated 1 million people in the United States. There are currently no approved therapies that are effective in improving vision in patients with geographic atrophy.

“CIRM is proud to continue to fund this groundbreaking stem cell therapy that has the potential to improve outcomes for the millions of people suffering from geographic atrophy,” said Maria T. Millan, M.D., President and CEO of CIRM. “This investment is follow-on funding to CIRM’s previous support to develop this therapy. It reflects our commitment to advancing cutting-edge science and underscores our dedication to addressing the unmet medical needs of those affected by degenerative diseases.”

This month’s clinical awards include two preclinical projects and four clinical-stage projects. That brings the number of CIRM-funded clinical trials to 95. For more information on CIRM’s clinical stage program, please visit our Funding Opportunities page.

CIRM grants, Bayh-Dole and stem cells: should one size fit all?

Last Thursday IP Finance welcomed a guest post by Mike Mireles on the current performance of the United States' Bayh-Dole Act.  Today we are happy to host a follow-up from the same author, also on Bayh-Dole but this time addressing the conflict between the opposed values of flexibility and certainty when funding R&D in the field of stem cells  Mike writes:

California Institute for Regenerative Medicine funding and the Bayh-Dole Act

In addition to federal resources, state funding in the United States may also be available to support the development of intellectual property.  In 2004, the voters of the state of California voted by proposition to allocate $3 billion to finance stem cell research.  The funding is distributed by the California state agency, the California Institute for Regenerative Medicine or CIRM.  After hearings concerning the administration of the funding, regulations were adopted to govern CIRM grants that generally follow the Bayh-Dole Act, but include some changes such as revenue-sharing with the State of California, the requirement of the creation of "access plans" for Californians that cannot afford the CIRM funded drug, and pricing for drugs developed from CIRM funding through the California Discount Prescription Drug Program.  

After funding many projects (see here), a recent Institute of Medicine of the National Academies report has called for numerous changes to regulations concerning CIRM grants including suggesting that the regulations are modified to follow the Bayh-Dole Act more closely -- apparently for reasons associated with consistency that will lead to more certainty.  Should concerns with certainty trump the interest in experimenting with modifying Bayh-Dole Act type legislation, perhaps leading to a Bayh-Dole Act that better benefits the public?  Shouldn't local conditions and concerns warrant changes in Bayh-Dole type legislation?  Does a one-size fits all approach make sense -- let alone for states, but even for different countries adopting Bayh-Dole Act type legislation?