gehandelt, die meldung von huete morgen schlägt bestimmt wieder ein wie eine bombe. bin gestern rein in usa, hier nochmals die originalmeldung:
XKEM (OTCBB)
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Xechem Receives Orphan Drug Designation From The FDA For Its Anti-Sickling Drug 5-HMF
TUESDAY , JUNE 06, 2006 06:30 AM
NEW BRUNSWICK, N.J., Jun 06, 2006 (BUSINESS WIRE) -- 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.
SOURCE: Xechem International, Inc.
Xechem International, Inc.
Stephen Burg, 707-426-8855
