Xechem Files Orphan Drug Application with the FDA For The Anti-Sickling Compound Licensed From Virginia Commonwealth University Business Editors
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--March 14, 2006-- Xechem International, Inc. (OTC BB: XKEM) Xechem International announced today that it has submitted its Orphan Drug Application for the five-membered heterocyclic anti-sickling compound known as 5-HMF to the United States Food and Drug Administration (FDA).
Research Shows Efficacy of 5-HMF
As reported on December 9, 2005, this promising compound has shown excellent biological activity in preliminary testing as an anti-sickling agent. This was discovered by Prof. Donald Abraham and his team of scientists from Virginia Commonwealth University (VCU), Richmond, VA in collaboration with a team of doctors and scientists at NHLBI Sickle Cell Disease Reference Laboratory at The Children's Hospital of Philadelphia (CHOP), University of Pennsylvania led by Professor Toshio Asakura. Xechem has acquired the exclusive, worldwide rights from VCU for the production, sales and marketing of 5-HMF for use in the battle against SCD.
Research has shown that the 5-HMF compound is not only a natural product with very little if any toxicity, it also appears to be an effective anti-sickling agent which has shown high affinity for hemoglobin and is very active in genetically modified transgenic (Tg) mice. Professor Abraham of VCU has characterized this compound as "the best potential antisickling agent in 30 years research to be discovered by (VCU's) research group." See Xechem's December 9, 2005 Press Release.
If granted, Orphan Drug status will afford Xechem seven years of marketing exclusivity for the drug once the drug is ultimately approved by the FDA, and will offer Xechem tax credits, filing fee waivers and certain other statutory benefits.
5-HMF Complements Xechem's Existing Arsenal for Treatment of Sickle Cell Disease
According to Xechem's Chairman and CEO, Dr. Ramesh C. Pandey, "This new compound licensed from VCU represents the latest effort undertaken by Xechem in the fight against Sickle Cell Disease (SCD), and adds to Xechem's existing arsenal of NICOSAN(TM)/HEMOXIN(TM), an all natural, phyto-pharmaceutical product that has shown enormous promise for SCD sufferers. NICOSAN(TM)/HEMOXIN(TM) has already been designated as an Orphan Drug both in the United States and in European Union countries. It was acquired under an exclusive worldwide license from the National Institute for Pharmaceutical Research and Development (NIPRD), Ministry of Health, Government of Nigeria, Between the progress we have been making in bringing NICOSAN(TM) to market, and this exciting new heterocyclic pharmaceutical agent being developed in collaboration with VCU, we expect Xechem to be front and center in eventually offering the most viable and efficacious treatments to patients suffering with SCD around the world." Dr. Pandey added that the Company intends shortly to prepare and file an Investigational New Drug (IND) Application for submission to the FDA for both HEMOXIN(TM) and 5-HMF.
About Sickle Cell Disease
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, more than 25% of the population are carriers of the SCD trait and over 4.5 million Nigerians (about 5% of the population) are actually afflicted with the disease. Approximately 15 million people, mostly in sub-Saharan Africa, are believed to suffer from this disease worldwide.
Xechem International, Inc. is a development stage biopharmaceutical company focusing on anticancer, antiviral (including AIDS), antifungal, Sickle Cell Disease (SCD), antimalarial and antibacterial products from natural sources, including microbial and marine organisms as well as the development of phyto-pharmaceuticals and other proprietary technologies, including those used in the treatment of orphan diseases. Xechem's mission is to bring relief to the millions of people who suffer from these diseases. Its primary attention and resources are currently being directed toward the development and commercial launch of the phyto-pharmaceutical NICOSAN(TM)/HEMOXIN(TM), which has shown efficacy in the treatment of SCD.
Forward Looking Statements
This press release contains certain forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, which are intended to be covered by safe harbors created hereby. Such forward-looking statements involve known and unknown risks and uncertainties.
KEYWORD: NORTH AMERICA NEW JERSEY UNITED STATES INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS PHARMACEUTICAL RESEARCH & SCIENCE PRODUCT/SERVICE SOURCE: Xechem International, Inc.
CONTACT INFORMATION: Xechem International, Inc. Stephen Burg, 707-425-8855
Posts: 842 | From: Canada | Registered: Oct 2005
| IP: Logged |