PharmaGap Announces Start of Definitive Animal Efficacy Study Required to Proceed to Clinical Trials
November 15 2011 - 7:00AM
Marketwired
PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF)("PharmaGap" or "the
Company") today announced successful completion of a Maximum
Tolerated Dose ("MTD") Study and commencement of an in vivo
efficacy study using human ovarian cancer in validated mouse
models. This in vivo test is the definitive efficacy test in
animals required for GAP-107B8 prior to proceeding to clinical
trials in humans. PharmaGap expects to announce completion of these
tests on or about December 20th. Results of the tests will be
announced when data compilation and analysis is completed, expected
to be during January 2012.
Earlier studies in similar ovarian cancer mouse models using
non-liposomal formulations of GAP-107B8 showed reduced tumour
burden (19%) and a significant suppression of malignant ascites
formation (73%). Malignant ascites is a significant cause of
morbidity in women with ovarian cancer, and is also present in
other forms of cancer as well as being associated with increased
level of metastases of many cancers.
Since that result was produced, PharmaGap has successfully
developed and tested liposomal formulations of its cancer drug
GAP-107B8 in order to enhance efficacy at reduced dose levels.
The MTD study was designed to provide the final dose range for
each of the four GAP-107B8 formulations that will be tested in the
in vivo ovarian studies now underway.
The outcome of the current in vivo test will provide the Company
with the basis for selection of one formulation of GAP-107B8 with
which to proceed to cGMP manufacturing, GLP Toxicology studies
required for clinical trial application, and the clinical trials
themselves.
About PharmaGap Inc.
PharmaGap Inc. (TSX VENTURE:GAP), based in Ottawa, ON, is a
biotechnology company with a core focus on developing novel peptide
therapeutics for the treatment of cancer. PharmaGap's GAP-107B8 is
a novel peptide drug that has been shown to be highly cytotoxic to
numerous cancer types, including chemo-resistant cancers, in vitro.
For more information on PharmaGap please visit the Company's
website at www.pharmagap.com.
Forward Looking Statements
This news release contains certain statements that constitute
forward-looking statements as they relate to the Company and its
management. Forward-looking statements are not historical facts but
represent management's current expectations of future events, and
can be identified by words such as "believe", "expects", "will",
"intends", "plans", "projects", "anticipates", "estimates",
"continues", and similar expressions. Although management believes
that expectations represented in such forward-looking statements
are reasonable, there can be no assurance that they will prove to
be correct.
By their nature, forward-looking statements include assumptions
and are subject to inherent risks and uncertainties that could
cause actual future results, conditions, actions or events to
differ materially from those in the forward-looking statements. If
and when forward-looking statements are set out in this news
release, PharmaGap will also set out the material risk factors or
assumptions used to develop the forward-looking statements. Except
as expressly required by applicable securities laws, the Company
assumes no obligation to update or revise any forward-looking
statements. The future outcomes that relate to forward-looking
statements may be influenced by many factors, including, but not
limited to: results of ongoing product testing and development;
regulatory approvals required to complete development of products;
ability to manufacture product at quality and scale for human use
on an economically sound basis; patient reimbursement by private
and public health insurance programs; unintended side effects of
products; competitive products; product liability; intellectual
property; reliance on key personnel; risks of future legal
proceedings; income tax matters; availability and terms of
financing; distribution of securities; effect of market interest
rates on price of securities, and potential dilution.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release. No Securities Commission or other
regulatory authority having jurisdiction over PharmaGap has
approved or disapproved of the information contained herein. This
release contains forward looking statements that may not occur or
may change materially.
Contacts: PharmaGap Inc. Robert McInnis President & CEO
613-990-9551bmcinnis@pharmagap.com
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