Message #17 From:
NewsBot Date: October 4, 2006 03:30:00 AM
XKEM News Xechem Receives $473,181 SBIR Grant From NIH-NHLBI to Conduct Toxicity Studies of 5-HMF Compound
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Xechem International, Inc. (OTC BB: XKEM) announced today that it
has received a SBIR grant in the amount of $473,181 from the National
Institutes of Health, National Heart, Lung and Blood Institute
(NIH-NHLBI) to carry out the toxicity studies on the five-membered
heterocyclic anti-sickling compound known as 5-HMF. Researchers from
both Virginia Commonwealth University (VCU) and Children's Hospital of
Philadelphia (CHOP), University of Pennsylvania are expected to
participate in the 5-HMF trials.
As previously reported, Xechem acquired the exclusive worldwide rights
for 5-HMF in December 2005 under a license agreement with VCU and on May
26th, 2006, Xechem was successful in obtaining
Orphan Drug designation from the US Food and Drug Administration (FDA)
for the drug. Research led by Dr. Donald Abraham of 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, and his colleagues at the NIH-NHLBI
Sickle Cell Disease Reference Laboratory at CHOP.
According to Xechem's Chairman and CEO, Dr. Ramesh Pandey, "We are very
pleased to have received this significant grant to fund the toxicity
studies of 5-HMF, which has shown great promise as a new type of
anti-sickling agent that interacts specifically with intracellular
hemoglobin without interacting with other proteins in the body. The
grant award will allow us to immediately move forward on the 5-HMF front
as we continue with our ongoing efforts to expand our production
capability for our first sickle cell drug (NICOSANTM),
which was launched in Nigeria on July 6th, 2006.”
5-HMF is a single compound which, subject to further testing and trials,
could be effective for intravenous and/or oral use in the fight against
Sickle Cell Disease. Previously, the Company acquired the exclusive
worldwide license from the National Institute for Pharmaceutical
Research and Development (NIPRD), Ministry of Health, Federal Government
of Nigeria, for the research, development, manufacture, marketing and
distribution of NICOSAN™/HEMOXIN™,
an all Natural Herbal Drug (phyto-pharmaceutical) that was launched in
Nigeria on July 6th, 2006.
About Sickle Cell Disease
Sickle Cell Disease (SCD) is an inherited blood disorder caused by an
abnormality in the hemoglobin molecule. Patients with the disease often
produce stiff, abnormally shaped red blood cells that often do not flow
freely through the blood vessels. This can create clogs in the vessels,
which in turn can cut off the flow of normal hemoglobin and oxygen to
parts of the body, and can cause severe painful attacks or “crises”,
damage to various organs and shortened life spans. People with SCD often
suffer unpredictable painful crises several times a year lasting from a
few hours to a week or more. In the US, there are approximately 80,000
patients with SCD. In Nigeria, that number is believed to be
approximately 4 million, with an estimated 10 - 12 million sufferers
throughout the African continent. Worldwide, at least 16 million
individuals are believed to be afflicted with SCD.
About Xechem
Xechem International is a development stage biopharmaceutical company
working on Sickle Cell Disease (SCD), antimalarials, and antiviral
(including AIDS), anticancer, antifungal and antibacterial products from
natural sources, including microbial and marine organisms. 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. Xechem’s mission is to bring
relief to the millions of people who suffer from these diseases. Its
recent focus and resources have been directed primarily toward the
development and launch of NICOSAN™ (named
HEMOXIN™ in the US and Europe) for the
prophylactic management of Sickle Cell Disease (SCD). With the recent
Nigerian regulatory approval of NICOSAN™,
Xechem is now scaling-up the commercialization of the drug in Nigeria
and making preparations for the pursuit of US FDA and European
regulatory approval.
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.