PharmaGap Chooses Ovarian Cancer as Target for First Clinical Trials
October 24 2011 - 8:00AM
Marketwired
PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF) ("PharmaGap" or "the
Company") announced today that it has chosen ovarian cancer as its
target for completing its preclinical test program and clinical
trial program for its cancer drug GAP-107B8. This is a key step,
originally expected to be reached only by year end, to allow the
Company to proceed with its program for manufacturing to cGMP
(current Good Manufacturing Practices) standards, full GLP (Good
Laboratory Practices) toxicology testing using this cGMP material,
and dossier development required for filing for first clinical
trial application by the end of 2012.
PharmaGap has, during the course of 2011, pursued a program
designed to provide the basis for choosing between bladder cancer
and ovarian cancer as the primary indication by the end of 2011.
With this decision now made, it is able to focus 100% of its
efforts and resources on ovarian cancer for the continued
development of GAP-107B8 toward clinical trials.
The Company has chosen ovarian because it is confident that it
represents the best combination of probability of successful trials
and scope of market opportunity.
Dr. Ken Sokoll, Vice President, Clinical Development and Chief
Operating Officer of PharmaGap stated "We are very pleased that the
high quality, innovative model development work done by ITR staff
has provided us with very clear evidence for the choice, at this
time, to focus all of our efforts on our ovarian cancer program.
With this clear decision, we can focus all of our resources on
ovarian cancer, in a well validated mouse model of ovarian cancer.
This is a very positive, well determined result for our program. At
the same time, GAP-107B8 has consistently shown effect in vitro
against bladder cancer cells, and as such remains an attractive
secondary target for future development and expansion of the
GAP-107B8 target platform."
The in vivo test program in ovarian cancer will be undertaken in
well-validated cancer models, starting with a Maximum Tolerated
Dose ("MTD") study and followed by an efficacy study using
GAP-107B8, including enhanced variants and liposomal formulations,
and employing three human cancer cell lines. These studies will be
undertaken during the next 10 weeks.
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.
Note: 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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