from the Overview section of the 10K
Overview
We are a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. We are developing a pipeline of products, stored ready-to-use, that are derived from human placenta, a non-controversial, non-embryonic, adult stromal cell source. The placental adherent stromal cells (ASCs) are grown in the Company's proprietary PluriX™ three-dimensional bioreactor, which imitates the natural microstructure of the body.
We are currently focusing on clinical indication that the route of administration is intramuscular, which means that the cells are administrated locally to the muscle and not systemically. This route of administration may be applicable for several different indications, such as: peripheral artery disease (PAD), critical limb ischemia (CLI), intermittent claudication, neuropathic pain, wound healing and orthopedic injuries. In addition we reported pre-clinical studies utilizing our proprietary PLX during the systemic administration in treating for multiple sclerosis, ischemic stroke, and inflammatory bowel disease.
Our first product in development, PLX-PAD, is intended to improve the quality of life of millions of people suffering from PAD. Phase I clinical trials for PLX-PAD are now in progress in Germany and the US. The Phase I study is designed to evaluate the safety of using PLX-PAD in patients with CLI, the end stage of PAD.
Following receipt of Food and Drug Administration (FDA) and European authority approvals, we commenced enrollment of patients for our Phase I clinical trials of PLX-PAD in June 2009 in Germany and in September 2009 in the US. A total of 15 patients were enrolled in the trial in Germany. The last patient was dosed in this trial in April 2010, representing the complete patient enrollment in that country. In the US trial, which is performed at three sites, a total of up to 12 adults with the disease will be included.
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On September 14, 2010 we announced interim results from our Phase I clinical trials in both the U.S. and Germany utilizing our PLX-PAD product. The 3 month clinical follow-up data include 21 patients, representing 77% of the patients required to complete the Phase I trials. The interim results suggest that PLX-PAD is potentially safe and well tolerated.
Both trials have currently met their primary safety endpoints. Further, the administration of PLX-PAD cells did not induce an immune response in any of the patients dosed, demonstrating that injection of PLX-PAD cells is well tolerated. In addition, the Phase I trials were designed to evaluate certain efficacy parameters, and the interim results suggest that the use of our PLX-PAD product was effective according to such parameters. Such efficacy parameters do not include all parameters required under applicable regulations to determine that our PLX-PAD product is effective, which will be the subject of the next stages of the clinical trials process that we plan to conduct. |
