in-the-news
posted on
Jul 20, 2012 03:34PM
Adult stem cell development company commencing clinical trials applicable to estimated $30 billion degenerative disease market place
''Pluristem Therapeutics Inc. (PSTI) ($3.20, market cap: $143.42M) is a developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases.
PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem is focusing on the use of PLX cells administered locally to treat systemic diseases and potentially obviating the need to use the intravenous route. Data from two phase I/II studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease when given locally. Additionally, Pluristem is developing PLX-PAD for cardiac ischemia; PLX-BMP for Acute Radiation Exposure; Bone Marrow Transplant Failure and Chemotherapy induced Bone Marrow Aplasia; PLX-ORTHO for orthopedic indications; and PLX-PAH for Pulmonary Hypertension in collaboration with United Therapeutics. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic indications, including diastolic heart failure, inflammatory bowel disease, neuropathic pain and pulmonary fibrosis. Pluristem has a strong patent portfolio; GMP certified manufacturing and research facilities, as well as strategic relationships with major research institutions.
The company's main technology, The PluriX Bioreactor System is designed to be a system of stromal cell cultures and substrates that create an artificial physiological environment where adherent stromal cells (ASCs) can grow and reproduce outside of the human body. Unlike conventional two-dimensional (2D) culturing methods, the Company's PluriX Bioreactor creates a three-dimensional (3D) microenvironment that closely resembles the structure and function of the body's bone marrow environment. By mimicking the natural environment that exists within human bones, the system tricks stem cells into growing and reproducing in the same way they would in living organs. Because the size and scale of the PluriX Bioreactor is larger than that of human bone marrow, stem cell growth can be greatly expanded.
The company believes that intramuscular administration, which means that the cells are administered locally to the muscle and not systemically, may be suitable for a number of different clinical indications. Such indications include peripheral artery disease, or PAD, critical limb ischemia, or CLI (the end stage of PAD), intermittent claudication, or IC (a subset of PAD), muscle injuries, thromboangiitis obliterans, or Buerger's disease, neuropathic pain, wound healing, orthopedic injuries and acute myocardial infarction. Under an exclusive license agreement, or the United Agreement, with United, the company plans to participate in the development and commercialization of a PLX cell-based product for the treatment of pulmonary arterial hypertension, or PAH.
On June 20th, the company said it has been in contact with drug makers to set up partnerships for its flagship blood-circulation disease treatment, PLX-PAD.
After completing two initial clinical trials involving different forms of peripheral artery disease, or PAD, Pluristem plans to start a late-stage study in 2013 of PLX-PAD's effectiveness in the disease's critical limb ischemia stage.
Pluristem Chief Executive Officer Zami Aberman remarked in a phone interview with Bloomberg BusinessWeek:
We are talking to more than one of the larger pharmaceutical companies about the possibility of out licensing our treatment,. We are not under pressure as we are sitting on about $40 million in cash, but if the deal is good enough, we'll take it.
On July 18th, the company announced that CPC Clinical Research will be managing the company's upcoming Phase II clinical trial for its proprietary stem-cell therapy in the treatment of peripheral artery disease. Pluristem said that CPC is a specialist in conducting clinical trials for the condition.
On May 9th, 2012, the company announced that a seven year-old girl suffering from an aplastic bone marrow whose condition was rapidly deteriorating is now experiencing a reversal of her condition with a significant increase in her red cells, white cells, and platelets following the intramuscular injection of the company's PLacental eXpanded (PLX) cells. Aplastic bone marrow is a disease where the patient has no blood-forming hematopoietic stem cells in the bone marrow. I found a YouTube video on this story as well for investors to take a look at. This kind of break-thru clearly indicates the company's tech works.
Stem cell technology is the wave of the future, but as I mentioned in the opening paragraph of this article, a company's stock structure and financial position has the greatest effect on whether or not we will see strong stock price appreciation now and in the future. Excessive warrants, bad financing, and burning too much cash will cause a stagnant stock price.''
http://seekingalpha.com/article/735141-stem-cell-therapy-the-investment-of-the-future?source=yahoo