JERUSALEM ¿ Proneuron Biotechnologies Ltd. rais ed $3.7 million to initiate clinical trials of its autologous macrophage cell therapy to stimulate regeneration in totally severed human spinal cord, and to finance further animal studies of a new T-cell therapy to block damage spread of partially damaged spinal cord.
Israel Infinity Venture Capital Fund L.P. in Tel Aviv invested $750,000 in Proneuron, increasing its stake in the company. Other investors included D.S. Polaris Ltd., and the Los Angeles-based Hudson Investment Group ¿ which with Lapid Medical Ventures in Tel Aviv and Nessuah-Zannex Venture Capital Management Ltd. in Ramat Gan had previously placed about $6.5 million in Proneuron. Giza Venture Capital in Tel Aviv joined these earlier investors to bring the current round to $3.7 million.
¿Phase I trials are recruiting at two medical centers, Tel Hashomer and Beilinson, in Tel Aviv, and are anticipated to run for several months, expecting one or two patients per month,¿ said Adrian Harel, company manager, speaking to BioWorld International from Proneuron¿s R&D and manufacturing facility in Ness Ziona.
¿For now, only recently injured patients will be eligible for inclusion ¿ very likely road accident or sporting victims with complete¿ spinal cord break and diagnosed as permanently paralyzed, but otherwise healthy,¿ said Valentin Fulga, Proneuron¿s director of clinical and regulatory affairs.
He said that in October, the U.S. FDA granted Proneuron the first-ever approval for clinical trials of a cell therapy to attempt regeneration of nerve cells following spinal cord injury.
This therapy that ¿mobilizes the body¿s own resources¿ is based on research by Michal Schwartz, professor in the Weizmann Institute of Science Neurobiology Department in Rehovot, who is Proneuron¿s chief scientist and chairwoman of the company¿s scientific advisory board.
Schwartz¿s research is elucidating key natural ¿neurotherapeutic¿ mechanisms consistently able to induce central nervous system regeneration in mammalian models, an ability available to non-mammalian vertebrates such as fish, frogs and reptiles. She has unraveled and proven in preclinical models the ¿hostile environment¿ caused by damaged nerve fibers that causes total paralysis following even partial spinal cord injury, leading to a cell therapy able to prevent secondary neural degeneration under development by Proneuron. And, she isolated immune privilege factor, a small peptide normally associated with the CNS that has strong immunosuppressive properties, and proved in animal studies its great potential for various neurological and ophthalmologic diseases.