The adult stem cell company BrainStorm Cell Therapeutics announced today that it has entered into an agreement with Protein Production Services, a leading manufacturing contractor, in order to begin production of its therapeutic adult stem cell product for the treatment of ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease). The production will commence in accordance with formal Good Manufacturing Practice (cGMP) production standards. Plans are also currently in development for use of the ALS product in a pre-clinical safety trial in which the product will be tested as a therapy in the animal model of ALS.
According to Rami Efrati, CEO of BrainStorm Cell Therapeutics, "We are very excited that we are moving into this phase of product development with a highly-experienced contractor that will enable us to move rapidly ahead with the final stages of our ALS pre-clinical program. As we announced on August 24 after securing new funding, BrainStorm now has both the financing and the production capabilities to achieve our goal of reaching human clinical studies in the coming year."
BrainStorm already boasts a portfolio of several patented, proprietary adult stem cell technologies, all of which are derived from autologous (in which the donor and recipient are the same person) adult stem cells harvested from bone marrow. Several of these products have already been successfully tested on various animal models of neurodegenerative diseases, with a number of the neuro-protective and neuro-regenerative properties of these products having been described in detail in more than a dozen peer-reviewed scientific publications.
As explained on the company’s website, BrainStorm Cell Therapeutics Inc. describes itself as "an emerging company developing adult stem cell therapeutic products, derived from autologous bone marrow cells, for the treatment of neurodegenerative diseases. The patent-pending technology is based on discoveries made by the scientific team led by Professor Eldad Melamed, former Head of Neurology at Rabin Medical Center, and cell biologist Dr. Daniel Offen, Head of the Neuroscience Laboratory at the Felsenstein Medical Research Center of Tel-Aviv University. The technology allows for the differentiation of bone marrow-derived stem cells into functional neurons and astrocytes, as demonstrated in animal models. The Company holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. The Company’s current focus is on ALS and Parkinson’s, although its technology has promise for treating several other diseases including MS, Huntington’s disease and stroke."
Established in 2005, Protein Production Services (PPS) describes itself as "an Israeli CRO/CMO for process development, production and purification of recombinant proteins" which "operates as a one-stop-shop for its customers, from cloning to cGMP production for phase I/II clinical trials, and has the capacity to produce in bacteria and mammalian cells." Additionally, PPS is developing its own platform of products known as "Biosimilar Plus".