Xechem Receives Orphan Drug Designation From The FDA For Its Anti-Sickling Drug 5-HMF
Xechem International, Inc. (OTC BB: XKEM) Xechem International announced today that it has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA), Office of Orphan Drug Products Development, for the five-membered heterocyclic anti-sickling compound known as 5-HMF for the treatment of patients suffering from sickle cell disease (SCD).
Research led by Dr. Donald Abraham of Virginia Commonwealth University (VCU) has shown 5-HMF to be "the best potential anti-sickling agent in 30 years of sickle cell research", performed by his group. 5-HMF not only is a natural product with very little, if any, toxicity, but it has a high affinity for sickle cell hemoglobin. It is also very active in genetically modified mice as shown by Dr. Toshio Asakura, Director, and his colleagues at the NIH-NHLBI Sickle Cell Disease Reference Laboratory at the Children\'s Hospital of Philadelphia, University of Pennsylvania.
According to Xechem\'s Chairman and CEO, Dr. Ramesh Pandey, "We are pleased with the FDA\'s decision granting Orphan Drug Designation to 5-HMF. This puts Xechem into a unique position where the company will have two drugs in the pipeline for treating patients with sickle cell disease. 5-HMF is a new type of drug that interacts specifically with intracellular hemoglobin without interacting with other proteins in the body. Today there are no non-toxic drugs available on the market to treat SCD. We are actively proceeding with our first drug (NICOSAN(TM)) in the hope of bringing it to the Nigerian market immediately following Nigerian regulatory approval. We are also preparing the Investigational New Drug (IND) application for 5-HMF for submission to the FDA in the coming months."
About Orphan Drug Designation
Orphan Drug status entitles a company to various incentives including the waiver of Regulatory Filing fees, access to potential grant funding for non-clinical and clinical research to generate required data for marketing approval, and seven years of marketing exclusivity for a designated drug once approved by the FDA. (Orphan diseases are generally defined as those afflicting less than 200,000 people in the US.)
About Sickle Cell Disease
Sickle cell disease is an inherited blood disorder caused by an abnormality in the hemoglobin molecule. Patients with this disease often produce stiff, abnormally shaped red blood cells that sometimes do not flow freely through blood vessels. This can create clogs in the vessels, which in turn cuts off the flow of normal hemoglobin and oxygen to parts of the body, and can cause severe painful attacks, damage to various organs, and shortened life span. In the US, there are approximately 70-80,000 patients suffering with sickle cell disease, many of whom suffer unpredictable painful crises several times a year lasting a few hours to a week or more. In Nigeria, more than 4 million persons have the disease. Worldwide, approximately 12 million are believed to suffer from this disease.
About Xechem
Xechem International, Inc. is a development stage biopharmaceutical company whose focus and resources are currently being primarily directed toward the development and commercial launch of NICOSAN(TM) (to be marketed as HEMOXIN(TM) in the United States and Europe), which has shown efficacy in the prophylaxis management of Sickle Cell Disease (SCD). In addition to NICOSAN(TM) and 5-HMF, Xechem is also working on anticancer, antiviral (including AIDS), antifungal, 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 focus is on the development of phyto-pharmaceuticals (Natural Herbal Drugs) and other proprietary technologies, including those used in the treatment of orphan diseases.
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.
Xechem International, Inc.
Stephen Burg, 707-426-8855
Source: Business Wire (June 6, 2006 - 6:30 AM EDT)
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