Pluristem Poised To Benefit From The Evolution of Regulatory Requirements

Los Angeles, July 23, 2012 - (ACN Newswire) - Trying to find companies that represent the future of the biotech sector can be tricky for investors. The sector currently leads the market because Food and Drug Administration (FDA) regulatory guidance is changing, with restrictions easing, and newguidelines being proposed and implemented.

The Obama Administration's 2011 directive towards the agency jump started aggressive investor speculation in the sector-- especially small cap developmental companies. Orphan drug designated medical devices, and subcutaneous self-injector medical devices all are benefiting from the progression of change currently occurring.

The hard part is trying to find the right company-- a company that does not over dilute shareholders, spends its money wisely, and has a legitimate shot at becoming a large revenue and profit producing company. Too many small cap biotech companies show promising technology, but have bad stock and financial structures. The key in small cap biotech investing is finding companies that structure their business with the main goal of both financial growth and technological advancement.

Antares Pharma (ATRS) is my largest holding because it fits the current regulatory changes occurring-- subcutaneous self-injection medical devices. I invested last year in Antares because I did my due diligence (DD) using all the factors mentioned above. I invested in Antares when it was $2.25 a share. As of this writing, its current stock price is $5.32.

Pluristem Therapeutics Inc. (NASDAQ:PSTI - News) is a company that should greatly benefit from the latest progression of regulatory evolution.

Pluristem 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/IIstudies 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 cellcultures 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 (PAD), critical limb ischemia (CLI-end stage of PAD), intermittent claudication (IC), muscle injuries, 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 August 22, 2011, the U.S. Food and Drug Administration (FDA) designated Pluristem's PLX cells orphan status for the treatment of thromboangiitis obliterans (Buerger's disease). The Company also announced that a concurrent application in Europe at the EMA's Committee for Orphan Medicinal Products is pending. Buerger's Disease isa rare and severe disease affecting the blood vessels of the extremities. It is characterized by inflammation and clotting of the vessels that result in a reduced blood flow to these areas. Severe pain and ulcers or necrosis of the extremities may occur, which may lead to amputation. Buerger's Disease affects approximately 50,000 patients in the United States and Europe. As there are no established treatments available, there is a strong medical need for the development of drugs for this indication. Various sources estimate the market for the treatment of Buerger's disease to be approximately $2.5 billion.

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Pluristem Poised To Benefit From The Evolution of Regulatory Requirements