International Stem Cell Corp. is a publicly traded biotechnology company concentrating on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. The company’s core technological platform, parthenogenesis, creates pluripotent human stem cells from unfertilized eggs. With treatment possibilities for patients with diseases of the eye, the nervous system, and the liver, parthenogenesis can take the field of regenerative medicine in a whole new direction. The technology has strong therapeutic potential for treating hundreds of millions of individuals whose treatability has been limited by a lack of available, safe immune-matched human cells.
Recently, International Stem Cell Corp.’s Board Co-Chairman and CEO, Andrey Semechkin PhD issued a letter to shareholders outlining the company’s R&D achievements in 2013 as well as its R&D goals for 2014. Among the company’s 2013 achievements were:
• A description of the company’s novel human neural stem cells for Parkinson’s disease featured in the March issue of Scientific Reports, a publication of one of the world’s leading scientific publishers
• Announcement in Q1 2013 of data showing that the neural stem cells provided positive benefit in a rodent model of Parkinson’s Disease
• Published and discussed rodent model results as well as the company’s first non-primate study at the 65th Annual Meeting of the American Academy of Neurology
• In August 2013, entered into master clinical research agreement with Duke University to conduct clinical trials in Parkinson’s Disease
• Demonstration of a new technology program’s ability to create stable stem cells, be at least ten times more efficient than older methods, and avoid the risks associated with methods based on viruses (This program aims to develop a new and more effective method of producing induced pluripotent stem cells. This new method both successfully enhances the efficiency of the reprogramming process using specific proteins called transducible transcription factors and avoids the use of viruses.)
• Demonstration of the company’s metabolic liver disease program therapeutic potential via results showing that hepatocyte-like cells, developed by the program, reduce toxin levels in the liver without causing any serious side effects or safety issues
Goals for 2014 were outlined as well:
• Pre-IND meeting with the FDA in Q1 2014 to review the company’s pre-clinical data, manufacturing protocols, and clinical study design for the company’s Parkinson’s Disease program
• Q1 2014 release of interim data from the company’s large-scale primate study began in 2013
• If the pre-IND and pre-clinical studies prove success, the company will file for its ND application for the treatment of Parkinson’s disease with neural stem cells in the second half of 2014
• Upon FDA review, assuming the submission receives approval the company intends to begin the first-in-man (FIM) Phase 1 clinical study for the Parkinson’s Disease program
Much more information, including more details on the milestones and objectives above, can be found in the shareholder letter here: http://www.internationalstemcell.com/2014_Shareholder_Letter
For more information regarding International Stem Cell Corp., visit: http://www.internationalstemcell.com
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