PharmaGap Preparing for Clinical Trials
05 April 2011 - 10:46PM
Marketwired
PharmaGap Inc. (TSX VENTURE: GAP)(OTCBB: PHRGF) ("PharmaGap" or
"the Company") expects to complete this year the selection of the
target cancer for clinical trials and to commence production of
formulated drug for use in these trials. "We are in the final
stages of pre-clinical work", Mr. Robert McInnis, CEO for PharmaGap
said. "We will be reporting frequently through this year as work
progresses to lead us to clinical trials next year. We are
encouraged by recent transactions in our industry indicating that
the strategy of carrying our work through Phase One Trials can
establish the basis for very meaningful value and returns to our
shareholders who have provided funding for this work over many
years".
The Company's lead cancer drug, GAP-107B8, has previously been
successfully tested in both in vitro and in vivo models using a
range of cancers.
PharmaGap is engaged in a program during 2011 leading to
application for initial clinical trials in 2012. This program is
directed by Dr. Ken Sokoll, Vice President, Clinical Development
and Chief Operating Officer. A principal objective for 2011 is the
selection of a single cancer target, using a specific route of
administration and dosing levels for that target, for the initial
clinical trial. Ovarian cancer and bladder cancer will continue to
be assessed, using formulated versions of the drug and alternate
routes of administration found in clinical settings.
Based on observations to date, a liposomal formulation approach
has been chosen in order to provide optimal stability and
effectiveness for PharmaGap's lead peptide drug GAP-107B8.
Activities are now underway within PharmaGap and at a number of
Contract Research Organizations to develop and finalize the
formulation. In order to provide the best possible opportunity for
success in clinical trials, the company has decided to continue to
focus work on both bladder and ovarian cancer through Q2 and Q3 and
into Q4 with a view to selecting the clinical trial candidate in Q4
of this year. The liposomal formulations of GAP-107B8 and three
clinically-accepted routes of administration will be tested to
provide the best possible basis to select the specific cancer
target, route of administration, and dosing levels to proceed to
clinical trials. Results of both formulation and animal tests will
be announced as they become available.
The Contract Manufacturer for the drug is expected to be
selected during the second quarter of this year for production of
the final form of the drug compound to meet quality, stability, and
quantity requirements for use in final pre-clinical testing and for
clinical trials. The Company expects to commence production of the
drug in the second half of 2011 for use in final testing in order
to support filing of applications for approval of initial clinical
trials in 2012.
While clinical trials are underway the Company will undertake a
program to identify additional cancer targets for future clinical
trials in order to expand the potential commercial market for
GAP-107B8.
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
613-990-9551 bmcinnis@pharmagap.com
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