{"id":498841,"date":"2024-01-29T15:13:02","date_gmt":"2024-01-29T20:13:02","guid":{"rendered":"https:\/\/platohealth.ai\/cirm-invests-26-million-in-clinical-stage-research-including-phase-2b-trial-for-bipolar-depression\/"},"modified":"2024-01-29T19:36:48","modified_gmt":"2024-01-30T00:36:48","slug":"cirm-invests-26-million-in-clinical-stage-research-including-phase-2b-trial-for-bipolar-depression","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/cirm-invests-26-million-in-clinical-stage-research-including-phase-2b-trial-for-bipolar-depression\/","title":{"rendered":"CIRM invests $26 million in clinical-stage research, including Phase 2b trial for bipolar depression\u00a0","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
<\/a>
Stock image of a dual tone brain by Getty Images<\/em><\/figcaption><\/figure>\n

South San Francisco, CA, Jan. 29, 2024 \u2013 <\/strong>The California Institute for Regenerative Medicine (CIRM), the world\u2019s largest institution dedicated to regenerative medicine, awarded almost $26 million to fund various clinical research \u2014 from treating bipolar depression to advancing a therapy for spinal cord injury. <\/p>\n

The awards will support four projects in the Agency\u2019s clinical program which provides funding for eligible stem cell and gene therapy-based projects through all stages of clinical trial development.  <\/p>\n

In addition, CIRM approved a concept proposal for the Community Care Centers of Excellence (CCCE), a new model for increasing clinical trial access to diverse communities throughout California.  <\/p>\n

The clinical awards approved at the CIRM January Independent Citizens\u2019 Oversight Committee (ICOC) meeting include: <\/p>\n

\n\n\n\n\n\n\n\n
Application #<\/strong>  <\/td>\nProgram Title<\/strong>  <\/td>\nPrincipal Investigator\/Institution<\/strong> <\/td>\nAmount<\/strong>  <\/td>\n<\/tr>\n
CLIN1-14840 <\/td>\nPrevention of GvHD in patients receiving HLA mismatched related or unrelated allogeneic HSCT for the treatment of hematologic malignancies <\/td>\nde Vries, David \u2013 Tr1X Inc <\/td>\n$4,000,000 <\/td>\n<\/tr>\n
CLIN2-15085 <\/td>\nPersonalized antisense oligonucleotide therapy for rare pediatric genetic disease: 
SCN2A <\/td>\n		Kim-McManus, Olivia \u2013 UCSD <\/td>\n$985,713 <\/td>\n<\/tr>\n
CLIN2-15395 <\/td>\nA Phase 2b Study of the Efficacy of a Novel Pro-Neurogenesis\/Pro-Plasticity Drug for Bipolar Depression Using a Precision Psychiatry Approach <\/td>\nEtkin, Amit \u2013 Alto Neuroscience <\/td>\n$15,000,000 <\/td>\n<\/tr>\n
CLIN1-15450 <\/td>\nHuman Embryonic Stem Cell-Derived Neural Stem Cells for Severe Spinal Cord Injury (SCI) <\/td>\nTuszynski, Mark \u2013 UCSD <\/td>\n$6,000,000 <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n

Improving the Treatment Landscape for Bipolar Depression <\/strong> <\/h2>\n

A $15 million award to Alto Neuroscience and Amit Etkin, MD, PhD, President and CEO of Alto Neuroscience will advance a Phase 2b trial to test a novel therapeutic treatment for bipolar depression (I or II), a condition that impacts 4.4% of U.S. adults at some point in their lives. <\/p>\n

The drug is designed to act on neural progenitor cells by enhancing the brain\u2019s ability to create new neurons and improve connections in the hippocampus, a specific region of the brain implicated in bipolar depression. <\/p>\n

Bipolar depression is a severe, life-long psychiatric condition associated with a significant burden of illness and risk of suicide. <\/p>\n

\u201cGiven the prevalence of bipolar depression and the high unmet medical needs of those facing this challenging disorder, this potential new therapy could expand treatment options to the hundreds of thousands of Californians impacted by this chronic neuropsychiatric disease,\u201d said Abla Creasey, PhD, Vice President of Therapeutic Development at CIRM.  <\/p>\n

Unlike current treatment options which consist of a regimen of antipsychotics and mood-stabilizing medications, this small molecule drug has the potential to offer better tolerability, and includes a diagnostic approach designed to identify patients who are most likely to benefit. <\/p>\n

Using Stem Cells to Restore Function after Spinal Cord Injury <\/strong> <\/h2>\n

Another project added to CIRM\u2019s clinical program includes a $6 million award to Mark Tuszynski, MD, PhD, from the University of California San Diego (UCSD) to explore the use of human embryonic stem cells to treat severe spinal cord injury (SCI). <\/p>\n

The proposed therapy works by implanting neural stem cells at the injury site to regenerate and repair damaged axons associated with SCI. <\/p>\n

SCI impacts more than half a million Americans and is associated with significant morbidity, including long-term and severe disability, chronic neuropathic pain as well as high healthcare costs. <\/p>\n

\u201cThe potential therapy represents a unique and forward-looking approach in the treatment landscape of severe spinal cord injury and underscores CIRM\u2019s commitment to advancing groundbreaking solutions to transform patients\u2019 lives,\u201d said Dr. Creasey. <\/p>\n

Improving Access to Treatments Across California <\/strong> <\/h2>\n

Additionally, CIRM approved a plan for the Community Care Centers of Excellence (CCCEs). The program is projected to award up to $60 million in CCCE awards. <\/p>\n

The California Stem Cell Research, Treatments, and Cures Initiative of 2020 (Proposition 14) mandates the establishment of the CCCE Program to promote access across the state to clinical trials, treatments, and therapies arising from CIRM-funded research. <\/p>\n

The CCCEs are designed to serve as a hub for expanding access to clinical trials, regenerative medicine treatments, and CIRM education and training programs. The program will seek to enlist community-based partnerships to engage populations that can benefit from these treatments. <\/p>\n

A strategic aim is to provide equitable access to communities and populations that would otherwise have more limited opportunities in the absence of these centers. <\/p>\n

Please direct any inquiries to Koren Temple-Perry, Senior Director of Marketing & Communications at press@cirm.ca.gov<\/a>.<\/em><\/p>\n