VioQuest Pharmaceuticals (CE) (USOTC:VOQP)
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VioQuest Pharmaceuticals (OTCBB: VOQP) today announced that the United
States Patent and Trademark Office has issued the first patent for the
company’s investigational product candidate
Lenocta™ (sodium stibogluconate). U.S. Patent
No. 7,416,723 entitled “Therapeutic
compositions and methods useful in modulating protein tyrosine
phosphatases,” encompasses novel
compositions including Lenocta for the treatment of cancer and a broad
range of other diseases.
“Based on Lenocta’s
demonstrated anti-tumor activity against melanoma, renal cancer,
prostate cancer, leukemia, and other cancers both alone and in
combination with other approved immune-activation agents, including IL-2
and interferons, we believe this product candidate represents a
promising approach to treating cancer,” said
Michael D. Becker, president and chief executive officer of VioQuest
Pharmaceuticals. “We are also enthusiastic
about the new FDA priority review voucher program, which could enable us
to accelerate development and commercialization efforts for Lenocta in
the treatment of leishmaniasis.”
Pentavalent antimonial compounds such as Lenocta are considered as a
first-line treatment for leishmaniasis, a protozoan infection usually
found in tropic and sub-tropic countries. The pharmacological mechanism
of action for pentavalent antimonials in treating leishmaniasis is not
fully understood, but research has indicated that the therapeutic effect
might be mediated via cellular targets. Researchers at The Cleveland
Clinic recently discovered that Lenocta inhibits specific protein
tyrosine phosphatases, which are relevant in the treatment of cancer and
other diseases.
VioQuest Pharmaceuticals licensed rights to sodium stibogluconate from
the Cleveland Clinic Foundation and is developing the drug as a protein
tyrosine phosphatase inhibitor for a range of potential indications.
According to the results of both preclinical and clinical trials:
Lenocta has marked and broad anti-tumor activity in vivo as a
single agent at a dosage that may be clinically achievable and well
tolerated;
The demonstrated synergy between Lenocta and various cytokine
therapies in vivo indicates that combination therapy with
Lenocta could significantly improve efficacy of current cytokine
therapies in cancer treatment; and
Because Lenocta inhibits certain protein tyrosine phosphatases with a
distinct mechanism of action, it may be useful as an alternative
therapeutic for cancers that are non-responsive or resistant to
conventional therapies.
Lenocta is in a Phase 2a clinical trial as a potential treatment for
melanoma, renal cell carcinoma, and other solid tumors. For information
about the study, please visit http://www.clinicaltrials.gov/
and use the search term “NCT00629200.”
The clinical status was recently updated at the 2008 ASCO annual meeting
in an oral presentation by Dr. Aung Naing from MD Anderson.
VioQuest Pharmaceuticals is planning to utilize historical published
data and an observational study of approximately 400 U.S. Army patients
to support a New Drug Application (NDA) for Lenocta. The approval of
this NDA could position VioQuest Pharmaceuticals to receive a priority
review voucher offered through the recently enacted Food and Drug
Administration Amendments Act of 2007 (Section 524 to the Federal Food,
Drug and Cosmetic Act or FFDCA). Designed to encourage the development
of treatments for tropical diseases, a priority review voucher will be
awarded to a sponsor upon approval of a tropical disease product
application. A tropical disease product application is a new chemical
entity human drug application that is itself deemed eligible for
priority review under the preexisting priority review criteria and is
approved for use in the prevention, detection, or treatment of a
tropical disease. A priority review voucher may be redeemed for priority
six-month review of one new drug application submitted under Section
505(b)(1) of the FFDCA or one biologics license application submitted
under Section 351 of the Public Health Services Act that would otherwise
be reviewed under FDA’s standard 10-month
review clock. The FDA's new priority review voucher program is scheduled
to go into effect in September of 2008.
About Lenocta
Lenocta (sodium stibogluconate) is a selective, small molecule inhibitor
of certain protein tyrosine phosphatases (PTPs), such as SHP-1, SHP-2
and PTP1B, with demonstrated anti-tumor activity against a wide spectrum
of cancers both alone and in combination with other approved immune
activation agents, including IL-2 and interferons. PTPs are a family of
proteins that regulate signal transduction pathways in cells and have
been implicated in a number of diseases including cancer, diabetes, and
neurodegeneration.
In addition to its potential role as a cancer therapeutic, sodium
stibogluconate has been approved in many countries around the world as a
first-line treatment of leishmaniasis, an infection typically found in
tropic and sub-tropic developing countries. Historical published data
and a large observational study conducted by the U.S. Army, including
data from approximately 400 patients, will support a New Drug
Application for Lenocta with the FDA. Lenocta has been granted Orphan
Drug status for leishmaniasis.
About VioQuest Pharmaceuticals
VioQuest Pharmaceuticals is a New Jersey-based biotechnology company
dedicated to becoming a recognized leader in the successful development
of novel drug therapies targeting both the molecular basis of cancer and
side effects of treatment. VioQuest’s
oncology portfolio includes: Xyfid™ (1%
uracil topical) for the treatment of dry skin conditions and manage the
burning and itching associated with various dermatoses; VQD-002
(triciribine phosphate monohydrate), a targeted inhibitor of Akt
activation; and Lenocta™ (sodium
stibogluconate), an inhibitor of certain protein tyrosine phosphatases
such as SHP-1, SHP-2, and PTP1B.
Further information about VioQuest can be found at www.vioquestpharm.com.
This press release contains forward-looking statements that involve
risks and uncertainties that could cause VioQuest's actual results and
experiences to differ materially from the anticipated results and
expectations expressed in these forward-looking statements. These
forward-looking statements concern the timing, progress and results of
the clinical development, regulatory processes, potential clinical trial
initiations of VioQuest’s product candidates,
as well as our ability to complete strategic transactions. These
statements are often, but not always, made through the use of words or
phrases such as anticipates, expects, plans, believes, intends, and
similar words or phrases. These statements are based on current
expectations, forecasts and assumptions that are subject to risks and
uncertainties, which could cause actual outcomes and results to differ
materially from these statements. These statements are subject to
various risks and uncertainties and include VioQuest’s
immediate need for additional capital to cover its current obligations
and future operating expenses and fund its clinical development
programs, the possibility that the results of clinical trials will not
support VioQuest's claims, the possibility that VioQuest's development
efforts relating to its product candidates will not be successful, the
inability to obtain regulatory approval of VioQuest's product
candidates, VioQuest's reliance on third-party researchers to develop
its product candidates, its lack of experience in developing and
commercializing pharmaceutical products, and the possibility that its
licenses to develop and commercialize its product candidates may be
terminated. Additional risks are described in VioQuest's Annual Report
on Form 10-KSB for the year ended December 31, 2007. VioQuest assumes no
obligation and does not intend to update these forward-looking
statements, except as required by law.