Message #19 From:
NewsBot Date: October 23, 2006 04:43:00 AM
XKEM News Xechem Announces ``Notice of Allowance'' for a Patent Relating to a Method of Treating Sickle Cell Disease With 5-HMF Compound Licensed from VCU
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Xechem International, Inc. (OTC BB: XKEM) announced today the
United States Patent and Trademark Office has issued to Virginia
Commonwealth University (VCU) a notice of patent allowance relating to a
method of treating Sickle Cell Disease (SCD) with a unique 5-membered
heterocyclic anti-sickling agent known as 5-HMF. A notice of allowance
is a written notification that a patent application has cleared an
internal review and is nearing issuance.
The exclusive, worldwide rights for the production, sales and marketing
of 5-HMF for use in the battle against SCD belong to Xechem as part of a
collaborative licensing agreement with VCU. In May 2006, Xechem was
successful in obtaining Orphan Drug designation from the US Food and
Drug Administration (FDA) for use of 5-HMF by patients afflicted with
SCD.
Xechem also announced recently 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 5-HMF.
5-HMF is a Pure Compound
Research led by Donald Abraham, Ph.D., professor of medicinal chemistry,
VCU School of Pharmacy, has shown that 5-HMF, a pure compound with very
little, if any, toxicity, has a high affinity for sickle cell hemoglobin
and may be effective in the treatment of SCD. “Our
findings suggest that this anti-sickling agent may lead to new drug
treatments and may one day help those suffering with SCD. This molecule,
5-HMF, is the most promising molecule to treat sickle cell anemia to
come from our research group in more than 30 years,”
Abraham said.
With the addition of 5-HMF, Xechem has now been able to expand its
potent arsenal for treating Sickle Cell Disease beyond its Natural
Herbal Drug, NICOSAN™, which was approved on
July 3rd, 2006, by Nigeria’s
National Agency for Food and Drug Administration and Control (NAFDAC)
and is currently being sold in Nigeria on a limited basis.
According to Xechem's Chairman and CEO, Dr. Ramesh C. Pandey, "With all
of the excitement over the recent commercial launch in Nigeria of NICOSAN™,
our all Natural Herbal Drug, there has been less attention focused on
our other SCD product, 5-HMF, which also represents an extremely
promising potential treatment for patients suffering with this terrible
disease. As a pure compound, 5-HMF is the perfect complement to our
herbal product and together with NICOSAN™
places us in a unique position of providing much needed efficacious
treatment for this painful and debilitating condition. As the exclusive
licensee for this product, we are very pleased to have the protections
that a patent allowance affords to VCU and to us.”
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.