XKEM: Amsterdam News Major Breakthrough Story! ...
Major breakthrough in fight against sickle cell disease.
by HERB BOYD
Special to the AmNews
Originally posted 1/4/2006
With two recent victories under its belt, there is reason for optimism at Xechem, a development stage biopharmaceutical company that has been working diligently to produce and market a drug to fight against Sickle Cell Disease (SCD). Recently, Xechem International announced that it had acquired the exclusive, worldwide licensing rights to a new five-membered heterocyclic anti-sickling compound from Virginia Commonwealth University (VCU). “Early research has shown this anti-sickling agent to be highly effective and a relatively non-toxic treatment for Sickle Cell Disease,” a press release from Xechem said. This new compound, the company stated, will further expand Xechem’s portfolio of products in its fight against this disease that is so common among Africans and African Americans. Acquiring this compound bolsters Xechem’s portfolio, which already includes a license from the National Institute of Pharmaceutical Research and Development, Ministry of Health, Government of Nigeria, for the manufacture, marketing, and distribution of NICOSAN/HEMOXIN, an all natural, phyto-pharmaceutical product that has also shown enormous promise for SCD, according to Xechem. NICOSAN/HEMOXIN has been granted an “Orphan Drug” status by both the U.S. Food and Drug Administration and the European Union’s regulatory body. The company is currently preparing an Investigational New Drug (IND) application for submission to the FDA and EU agencies. ''We know of no existing non-toxic medicines available anywhere in the world for the effective treatment of Sickle Cell Disease,” said Dr. Ramesh C. Pandey, Xechem's Chairman and CEO. “Between our existing product, NICOSAN™/HEMOXIN™, a non-toxic product that has shown excellent results in Phase IIA and Phase IIB clinical trials in Nigeria, and this promising new heterocyclic pharmaceutical agent being developed in collaboration with VCU, Xechem will be in a truly unique position to offer viable and efficacious treatments to patients suffering with this painful and debilitating condition.” Along with the acquisition of the VCU licensing agreement, last week Xechem announced it had settled its anti-trust lawsuit against Bristol-Myers Squibb Company for $4.2 million. The lawsuit, filed two years ago, stemmed from Xechem’s allegations that Bristol Myers “had engaged in anti-competitive practices relating to Xechem’s efforts to manufacture and bring to market the drug paclitaxel, a generic equivalent to Bristol’s cancer drug, TAXOL ®.” The settlement, according to Dr. Pandey, will further his company’s plans to launch its sickle cell drug. “The settlement with Bristol Myers could not have come at a better time for Xechem,” he said. Dr. Pandey has a distinguished career in the biomedical sciences spanning over 35 years and has served with numerous universities, government agencies and pharmaceutical companies worldwide. He came to the United States from India in 1967 with a Ph.D. in medicinal chemistry and spent three post-doctorate years at the University of Illinois-Champaign Urbana, IL with Professor Kenneth L. Rinehart, Jr. Xechem International, Inc. is a development stage biopharmaceutical company focusing on anticancer, antiviral (including AIDS), antifungal, Sickle Cell Disease, antimalarial and antibacterial products from natural sources, including microbial and marine organisms. Xechem’s mission is to bring relief to the millions of people who suffer from these diseases. Its primary focus is on the development of phyto-pharmaceuticals and other proprietary technologies, including those used in the treatment of orphan diseases. Its primary attention and resources are currently being directed toward the development and commercial launch of NICOSAN™/HEMOXIN™, which has shown efficacy in the treatment of SCD. Sickle Cell Disease is a genetic blood disorder caused by an abnormality in the hemoglobin molecule. Patients with this disease often produce stiff, abnormally shaped cells that do not flow freely through blood vessels, creating clogs in the vessels, which in turn cut off the flow of normal hemoglobin and oxygen to the body. In Nigeria alone, according to a mini-documentary produced for Xechem by DDO Group LLC Harlem Edit, more than 25% of the population are carriers of the SCD trait and over 4.5 million Nigerians (~5% of the population) are actually afflicted with the disease. Approximately 12 million people, mostly in sub-Saharan Africa, are believed to suffer from this disease worldwide.
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