VioQuest
Pharmaceuticals (OTC Bulletin Board: VQPH) today announced that it will
proceed with Phase II trials later this year with its direct Akt inhibitor
VQD-002. Ongoing trials in patients with refractory leukemia and solid
tumors are expected to complete phase I enrollment in June 2007. VQD-002 is
a novel direct inhibitor of activation of Akt, a serine-threonine kinase
that is over expressed and or hyperactivated in resistant and refractory
tumors as well as in aggressive hematologic malignancies. Phase I/IIa
clinical trials are currently ongoing at the MD Anderson Cancer Center,
Houston, TX, and at the H. Lee Moffitt Cancer Center, Tampa, FL.
The objectives of the clinical trials in hematologic malignancies
conducted at MD Anderson and H. Lee Moffitt Cancer Center, include the
evaluation of VQD-002's safety profile, pharmacokinetic (PK) and
pharmacodynamic (PD) parameters, and the effects VQD-002 has on Akt
modulation. Eleven patients have been enrolled in the ongoing leukemia
trial. In the leukemia trial, reductions in malignant cells (peripheral
blast cells) have been seen in several of the patients following initial
therapy. Some patients have had improvements observed in parameters of
their bone marrow function (increases in platelet and neutraphil counts).
The objectives of the clinical trial in solid tumors conducted at H.
Lee Moffitt Cancer Center, include the evaluation of VQD-002's safety
profile, pharmacokinetic (PK) and pharmacodynamic (PD) parameters, and the
effects VQD- 002 has on Akt modulation. Eleven patients with solid tumors
have been enrolled in the phase I portion of the ongoing solid tumor trial.
Several of these patients, refractory to prior standard therapy and who
were screened and selected for study based on the high level of Akt
expression in their tumors, have shown stable disease on study.
Phase I enrollment in both the solid tumor and leukemia trials is
expected to be completed in June 2007, with phase IIa expansion in each
trial starting immediately thereafter in patients with a variety of
resistant/refractory solid tumors and malignant leukemias. Akt screening
before and during patient treatment will continue to be performed on these
patients.
"As the pathophysiology of hematologic malignancies continues to be
dissected, Akt is emerging as an important therapeutic target for both
single therapeutic agent modulation and the development of combinatorial
molecular targeted therapeutics," said Professor Frank Giles, Director of
the Institute for Drug Development, CTRC and Chairman of the Division of
Hematology and Medical Oncology at the University of Texas Health Science
Center, San Antonio. "VQD-002 is an exciting novel agent in the context of
personalized medicine and molecular targeted therapeutics, coupled with
activities seen in the ongoing trials so far, we are enthusiastic about
investigating rapidly," said Professor Giles, who is Chairman of the
VioQuest Scientific Advisory Board.
"It is important to note that our Akt activation inhibitor not only
blocks the function of all three isoforms of Akt, but also does not result
in feedback upregulation of P-Akt levels as observed in other Akt
inhibitors. This is a selective, specific, and potent inhibitor of Akt
activation. Accordingly, VioQuest would like to exploit this advantage in
future combination studies," explained Said M. Sebti, Ph.D., M.D., Director
of Drug Discovery Program, Moffitt Cancer Center, Tampa, FL.
"While these phase I data should not be overinterpreted, the fact that
VQD-002 is being well-tolerated in this advanced patient population is
encouraging and supports the substantial and growing pre-clinical data
which points to Akt as a key cancer control pathway," said Edward C.
Bradley, M.D., VioQuest's Chief Scientific Officer.
Discussions of additional Phase II trials of VQD-002 used in
combination with other targeted therapies are underway and patient
enrollment in these trials could begin by the end of this year.
About VQD-002
VQD-002 is a novel direct inhibitor of activation of Akt, a serine-
threonine kinase that is overexpressed and or hyperactivated in resistant
and refractory tumors as well as in aggressive hematologic malignancies. In
a previous phase II study of this compound conducted by the National Cancer
Institute (NCI) in patients with metastatic or recurrent squamous cell
carcinoma of the cervix, patients were screened and were treated regardless
of their Akt expression levels. In this small, refractory phase II cohort,
1 patient had complete regression for 19+ months, another had partial
response for 5+ months, and 8 had stable disease. Subsequent advances in
research and technology allowed for a better understanding of the molecular
mechanism of action of VQD-002 and have demonstrated it's role in the
inhibition of the Akt pathway. Uses of these molecular biomarkers are being
employed in these newer trials with the hope that they guide more rational
patient selection and thus a higher chance of benefit for any individual
patient.
About VioQuest Pharmaceuticals
VioQuest Pharmaceuticals, Inc. vioquestpharm focuses on
acquiring, developing, and commercializing targeted late preclinical and
early clinical stage therapies with unique mechanisms of action for
oncology, viral and autoimmune disorders. VioQuest has two targeted
therapeutics in Phase I/IIa clinic trials: VQD-002 which inhibits
activation of Akt that is seen at abnormally high levels in breast,
ovarian, colorectal, pancreatic, and hematologic tumors; and Lenocta(TM),
an inhibitor of specific protein tyrosine phosphatases, which has shown
compelling preclinical activity in both renal and melanoma cancers. In
addition, VioQuest and the U.S. Army are planning to submit an NDA to the
FDA in 2007 for Lenocta(TM) for the treatment of leishmaniasis. VioQuest
also has recently in-licensed Xyfid(TM), a topical therapy which has shown
early clinical promise in the treatment and prevention of chemo-induced
hand-foot syndrome.
Forward-Looking Statements
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. Such statements
include, without limitation, statements regarding the expected timing of
the conclusion of enrollment on the ongoing Phase I clinical trials and the
initiation of Phase II trials of VQD-002. 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. Among
other things, there can be no assurances that VioQuest will meet its stated
timelines concerning the initiation and conclusion of clinical trials of
VQD-002 or that the data presented in this press release will be supported
by future clinical trials. Other risks and uncertainties include the
possibility that VioQuest's development efforts relating to its product
candidates, including VQD-002, will not be successful, the inability to
obtain regulatory approval of VQD-002 or 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, 2006. VioQuest assumes no obligation and does not intend
to update these forward-looking statements, except as required by law.
VioQuest Pharmaceuticals, Inc.
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