PharmaGap Completes Manufacturer Site Audits Required for Clinical Trial Submission
October 19 2011 - 8:00AM
Marketwired
PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF)("PharmaGap" or "the
Company") is pleased to report that quality audits for cGMP
(current Good Manufacturing Practices) grade peptide have now been
completed by PharmaGap under the direction of Dr. Ken Sokoll, Vice
President of Clinical Development and Chief Operating Officer. The
audits were performed at the manufacturers' sites and represent a
required step toward the submission of an Investigational New Drug
("IND") Application in the United States.
The manufacturers have produced research grade GAP-107B8 and
variants for PharmaGap's in vitro and in vivo testing and
development program over the past 12 months. The choice of
manufacturer is targeted to be made in November by Dr. Sokoll
following assessment of the manufacturers' capability for
cost-effectively delivering quality-controlled, stable product in
quantities and on an expedited timeline, which is required for use
in all future testing. This future testing includes scale-up of
liposomal formulations and formal GLP safety-pharmacology and
toxicology testing for GAP-107B8 during 2012, and all subsequent
testing in PharmaGap's clinical trials in humans thereafter.
Regulatory requirements for IND Applications provide that
pharmaceutical companies bringing new drugs into clinical trials
are ultimately responsible to ensure that processes are in place to
assure the control of outsourced activities and quality of
purchased materials. Audits of manufacturers are required in order
to meet PharmaGap's responsibility to assess, prior to selection of
manufacturer, the suitability of the manufacturer to produce in a
timely manner the drug product using defined procedures and quality
control systems.
Dr. Sokoll commented that "The completion of this audit process
and establishment of a manufacturer of clinical grade source for
GAP-107B8 peptide in November is a key component in our ability to
meet all testing and data generation requirements for the IND
submission next year."
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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