Stabilized, Controlled-Release Drug for PAOD

What is Peripheral Arterial Occlusive Disease?

Peripheral Arterial Occlusive Disease ( PAOD) or hardening of the arteries results from formation of atherosclerotic plaques caused by a number of factors including:

Untreated, PAOD progresses to:

Intermittent Claudication

Intermittent Claudication occurs when blood flow is sufficient to meet the needs of the patient at rest, however when exercising the blocked vessels limit the free flow of blood and oxygen does not meet the muscles’ demands. In response to the higher demand, the body reduces the chemicals that open blood vessels and increases chemicals that narrow blood vessels.

Currently, there is NO effective pharmacological therapy available for the treatment of intermittent claudication. With the prevalence up to 3% in young adults and up to 20% in adults over the age of 50, along with the increasing age in the population, there is a growing need for an effective treatment.

Additionally, PAOD is associated with a high level of morbidity with an estimated 30% of patients expected to die with five years of diagnosis.

Drug Benefits

This drug will significantly improve the quality of life for many individuals (12-14 million people in the USA alone) suffering from the following diseases:

Potential Market of the Drug

The American Heart Association (AHA) estimates that 12-14 million Americans have PAOD and that this disease is associated with significant morbidity and mortality. Of this approximately 50% of this patient population has been diagnosed with Intermittent Claudication with an estimated 6 million being undiagnosed. The prevalence of PAOD is expected to increase rapidly in the upcoming years as the "baby boomer" generation ages. Without an effective treatment on the market, patients who suffer from PAOD can experience serious effects such as leg ulcers, gangrene, tissue death and ultimately foot or leg amputation.

Based on the above mentioned indications it is obvious that this drug has a potential to attain blockbuster status upon marketing approval.

Competitive Advantage

Although there are other companies with products and research in the field of slow release technology, our client believes that none has a liposome delivery product that directly competes with their patented and patent-pending products in the US market. Our client believes that its patents and licenses will protect it from competition in its niche field.

Current treatment options for PAOD (Pletal, Trentanal, Plavix, Aspirin, etc) are limited to symptomatic control and are plagued with side-effects and limited efficacy. As of yet, there is no successful pharmacologic therapy to help disease regression or cure PAOD.

Recently, gene therapy has emerged as the most popular approach to treating this disease. Several companies have selected specific genes that have been shown to increase circulation to the extremities by stimulating angiogenesis to grow new capillaries and vessels to bypass occluded areas of the extremities. This drug achieves the same therapeutic endpoint by collectively stimulating many of the genes in the angiogenic pathway, via a cascade effect, in a safer and more effective manner to increase circulation. In essence, the approach currently taken by other companies today validates the premise upon which our drug is based.

Clinical Trials

The Company has targeted Peripheral Arterial Occlusive Disease (PAOD), specifically Intermittent Claudication a symptom of PAOD, as one disease for which this slow-release, stabilized drug would be greatly beneficial. Patients with PAOD go largely undiagnosed and under-treated, and there is a great need for improvement in less invasive treatment options.

The Phase I clinical trial to establish the compound’s safety, side effects and the
maximum tolerated dose (MTD) in healthy volunteers was successfully concluded in January of 2001.

A Phase II, open label multicenter study for this slow-release drug evaluated a treatment protocol in 73 patients suffering from PAOD, including critical limb ischemia (CLI) and intermittent claudication (leg pain). The results of the Phase II study were notably successful, with statistically significant improvements in maximum walking distance (MWD), the primary endpoint of the trial. Secondary endpoints of pain-free walking distance (PFWD), Peripheral Arterial Disease
Walking Impairment Questionnaire (PADWIQ), Ankle Brachial Index, Pain Score, and a quality of life assessment using the MOS SF-36 also achieved statistically significant improvements over baseline.

The efficacy analysis results, based on both primary and secondary endpoints, provide strong evidence that this drug is effective for the treatment of peripheral arterial disease and critical limb ischemia.

Phase IIIa Clinical Trials

Recently, our client has submitted its protocol for a phase IIIa clinical trial for the treatment of PAOD, specifically for Intermittent Claudication, a symptom of the disease, to the US FDA. The Phase IIIa trial will be a randomized, placebo-controlled, double-blinded, pharmacokinetic study of two dose levels of drug administered once-weekly for six weeks to a treatment group.

Next Steps

Our client is looking for licensing / strategic partners to help complete phase III trials in the US and take this product to market, while also proceeding to get approvals in other countries.

Contact Us

Do contact us for more information on this technology and to connect with our client.

 

copyright | policy | home

[XHTML 1.0] [CSS]