Industry Update: Capital market and finances
Latest capital market and finances developments compiled from 01 — 30 June 2016
Latest capital market and finance developments in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from non-academic institutions from 01 — 30 June 2016, scheduled to be published in Volume 11 Issue7 of Regenerative Medicine.
Green light
Cell Cure
BioTime’s (CA, USA; www.biotimeinc.com) subsidiary Cell Cure Neurosciences (Israel; www.cellcureneurosciences.com) received Data Safety Monitoring Board approval to start second patient cohort in a phase I/IIa clinical trial for advanced dry-form age-related macular degeneration (dry-AMD). Patients with dry-AMD will receive a higher dose of OpRegen®, an allogeneic cell therapy consisting of retinal pigment epithelial cells differentiated from human ESC (hESC), to evaluate the safety and efficacy of three different dose regimens of OpRegen® (clinicaltrials.gov identifier: NCT02286089). Cell Cure has recently been awarded a new grant for 2016 of 8.4 million shekels (approximately $2.2 million) from the Israel Innovation Authority (“IIA,” formerly the Office of the Chief Scientist) of the Ministry of Economy and Industry.
Cytori
Cytori Therapeutics (CA, USA; www.cytoru.com) has recently seen approval of Cytori Cell Therapyâ„¢ for clinical use to treat knee osteoarthritis at the Tokyo Osteoarthritis Clinic under the Japanese ‘Act on the Safety of Regenerative Medicine’. Tokyo Osteoarthritis Clinic will begin to treat knee osteoarthritis patients with Cytori Cell Therapy immediately. This approval is limited to facilities under the clinic’s umbrella but does not restrict the number of patients that can be treated. Such approvals are not reimbursed by the social healthcare system and patients will be responsible for the costs of treatment.
Stempeutics
Stempeutics Research (India; www.stempeutics.com) announced that the Drugs Controller General (India) has granted limited approval for manufacturing and marketing of proprietary product Stempeucel® for the treatment of critical limb ischemia due to Buerger’s Disease. Stempeucel consists of ex-vivo cultured adult allogeneic mesenchymal stromal cells isolated from multiple bone marrow donors, thus would become the first allogeneic product approved in India.
Guidance
Japan
The Japanese health ministry has drawn up guidelines for determiningthe safety of laboratory-created stem cell treatments in clinical trials, a step that
could pave the way for more such studies. The standards will be used to evaluate trials that involve transplanting iPSC into the human body. The safety standards call for testing these iPSC for signs that they may turn cancerous. Ideally, only cells without cancer-causing abnormalities should be used, but exceptions may be made in cases where the potential benefits of the trial outweigh the risks, according to the guidelines. The cells first would be transplanted into nonhuman subjects, such as rats, to check for cancer and other potential complications.
NCMC
The Georgia Research Alliance (GA, USA: http://gra.org) and the Georgia Institute of Technology (GA, USA; www.gatech.edu) have launched the National Cell Manufacturing Consortium (NCMC; http://cellmanufacturingusa.org), an industry-academic-government partnership that recently released the National Roadmap for Advanced Cell Manufacturing (http://cellmanufacturingusa.org/road-map). Establishment of the consortium and development of this 10-year national roadmap was sponsored by the National Institute of Standards and Technology (MD, USA; www.nist.gov). Established in 2014 through a NIST Advanced Manufacturing Technology grant, the NCMC is an industry-driven consortium including cell manufacturing experts from industry, academic research, clinical GMP centers, government agencies and private foundations.