Pluristem's Unique Therapy Primed to Replace Blockbuster Drugs for Treating Peripheral Arterial Disease

Posted: July 12, 2012 at 10:13 am

A close examination ofemerging biotech Pluristem Therapeutics (PSTI), whose unique cell therapy is being applied to a number of clinical disorders, shows promise.

Peripheral arterial disease (PAD), under-diagnosed and, in some cases, over-treated, is one of the fastest-growing conditions to affect an aging population. 10 million Americans have PAD today and the number is expected to rise to 23 million by 2014. Its presence signals circulatory problems that play into medicine`s largest industries - heart disease and stroke. We believe the market is ready for a new treatment, cell therapy, with lower overall cost, quicker healing time, no toxicity, and ease of administration - a simple intramuscular injection - to help improve the PAD sufferers` way of life.

Several big pharmas sell drugs for PAD including Bristol-Myers Sqibb Co. (BMY) and Sanofi (SNY) which sell Plavix; Teva Pharmaceuticals (TEVA) sells Pletal; AstraZeneca (AZN) sells Atacand; Bristol-Myers also sells Avapro; and Merck & Co. (MRK) sell Cozaar/Hyzaar. Combined sales for these drugs are well over $12 billion. Each of the drugs has side effects and they do not cure PAD. As an alternative, or in addition to drugs, cevices such as stents are surgeries are costly, risky, and not consistently effective.

Pluristem`s PLX cells offer a new paradigm to treat PAD by growing new vessels - offering a potential cure, not just a way to manage the disease.

Peripheral arterial disease (PAD), , is a vascular disease affecting the legs. Its cause is atherosclerosis, where blood flow within arteries becomes restricted from blood-borne debris, allowing plaque to form that narrows and hardens the vessel wall. The first indication of PAD is walking pain, known as intermittent claudication (IC). Left untreated, blood flow to the legs is further limited, resulting in critical leg ischemia (CLI), or dying arterial tissue; almost half of PAD patients with IC progress to CLI. At this point, ulcers and gangrene may develop with amputation as the only option.

Two goals are targeted when treating PAD: managing leg pain and halting the progression of atherosclerosis, which, when present, may be a signal that its appearance is elsewhere in the body, raising the risk of heart attack and stroke. Often doctors suggest combining medicine for PAD with procedural intervention. In severe cases, vascular surgery is recommended.

Pharmaceutical treatment for PAD falls in two major categories - drugs that improve blood flow and those that thin blood to avoid excessive clotting that intensifies atherosclerosis. Aspirin, coumadin, and heparin have been standards of care as anti-clotting agents that inhibit platelets, small cell fragments that circulate in blood, from forming clots.

Then came clopidogrel, or Plavix, made and sold by Bristol-Myers Sqibb Co. (BMY) and Sanofi (SNY). It works by inhibiting a receptor on platelet cell membranes so they become less `sticky` and clots are less likely to form. The drug quickly rose to blockbuster status and is today the second most prescribed pharmaceutical in the U.S., next to anti-cholesterol agent Lipitor, marketed by Pfizer, Inc. (PFE). Sales of Plavix were $7.1 billion in 2011, up 6% over the prior year, and accounted for 33% of Bristol-Myers` net revenue. Treatment with Plavix is lifelong.

Bestseller Plavix`s Surprising Drug Interactions and Alarming Side Effects

But there are problems with Plavix. Two years ago, the FDA put a `black box` warning on the popular drug, citing a lack of efficacy in an astounding 14% of patients. It was discovered that people with certain genetic characteristics simply cannot metabolize the drug, rendering it useless in the body. Sadly, the patient would need to take Plavix over time before it is determined that it doesn`t work, setting up a scenario of further arterial blockage. The only solution is a genetic test given either before or after administration of the drug - at price of $500 - and a wait time of two weeks.

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Pluristem's Unique Therapy Primed to Replace Blockbuster Drugs for Treating Peripheral Arterial Disease

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