Last month we examined emerging biotech Pluristem Therapeutics (PSTI), whose cell therapy treats vascular disease with a novel intramuscular injection that restores patency to damaged arteries. Now, this pioneering technique is showing promise in healing another medical disorder with few alternatives - failed bone marrow transplant (BMT).
BMT, a physically demanding ordeal unchanged in procedure since 1968, is performed on 30,000 patients per year at a cost of billions of dollars. Full recover takes up to one year. In the last few months, Pluristem has been making significant progress with a substitute for BMT. In May, a seven-year old girl with aplastic anemia was treated with two intramuscular injections of PLX cells after repeated failed BMTs, and showed rapid recovery in all three blood cell components as Pluristem`s therapy stimulated hematopoietic stem cells.
In June, the company`s data at the 2012 Bio International Convention showed positive results of an intramuscular injection of its PLX cells on a range of blood disorders that included primary and secondary bone marrow failure from chemotherapy and radiation therapy in cancer, and acute radiation syndrome (ARS). Now, a second patient with lymphoma has been treated with PLX cells for a failing BMT, in the same manner as the girl, with similar stunning results in only two weeks.
Drug firms pay much attention to finding new ways to circumvent the horrors of chemotherapy. Popular alternatives to traditional chemotherapy and pharmaceutical inventions intended to mollify its devastating consequences include drugs that inhibit certain biological responses, such as those marketed by Pfizer, Inc. (PFE) and Eli Lilly & Co. (LLY), and a crop of medicines designed to treat the effects of chemotherapy such as Aranesp made by Amgen, Inc. (AMGN) and Mesnex, by Baxter International (NAYSE:BAX). Hormone therapy is another widespread option, led by Herceptin made by Roche Group and Faslodex, by AstraZeneca plc (NAYSE:AZN).
The market for blood cancers is a multi-billion dollar industry, as evidenced by huge takeovers of leading cancer researchers by large pharma companies in the past - Genentech, bought for $44 billion by Roche Group; Genzyme Corp., for $20 billion by Sanofi (NAYSE:SNY); and most recently, speculation on Onyx Pharmaceuticals (ONXX), whose new monoclonal antibody for blood cancer is projected to see sales in the blockbuster range, for a take-out by Bayer AG, Takeda Pharmaceutical Co., or Celgene Corp. (CELG).
With promising results in stimulating hematopoietic stem cells as evidenced in these BMT success stories, Pluristem joins the ranks of leading cancer companies, and has already applied for Orphan Drug status for bone marrow anemia, its second such filing that would grant the company, among other benefits, closer guidance from the agency and, most importantly, a waiver of the required 1,000 patients for a Phase III clinical trial. In essence, the entire process done under the Orphan Drug regulation could be accomplished in weeks, not years, at a drastically reduced price. This could mark the beginning of another therapeutic offering from Pluristem`s platform technology that is less-invasive, with faster administration and vastly reduced recovery time than competing treatments.
About The Analyst: Sharon di Stefano
Sharon di Stefano has spent 20 years as a healthcare analyst, beginning her career at Smith Barney, Harris Upham & Co. specializing in medical devices, pharmaceuticals, health care information technology, and biopharmacology. Ms. di Stefano had also served as Senior Venture Officer for the Edison Innovation Fund, implemented through the New Jersey Economic Development Authority that provided funding for early-stage life sciences companies.
Ms. di Stefano received a Masters of Science degree, in Business, from Johns Hopkins University. In addition to raising over $100 million in funds for private and public life science companies, she has consulted for the Pharmacy Benefit Managers Association, Blue Cross of California, the Department of Defense, Wasserstein Perella, FleetBoston Capital Corporation, and Omnicom Group.
The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein.
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