PharmaGap Liposomal Formulations Achieve Key Milestones for Clinical Trials
November 25 2011 - 8:00AM
Marketwired
PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF) ("PharmaGap" or "the
Company") today announced that liposomal formulations of its cancer
drug have proven to meet and surpass expectations for three key
elements important for clinical trials - potency, pharmacokinetic
profile, and therapeutic index. Peptide half-life has been
increased from a range of 0.4 to 0.7 for unformulated peptides to
approximately 8 hours using intravenous administration and to
approximately 40 hours using intraperitoneal administration.
Liposomal associated peptide was detectable up to 72 hours post
administration indicating that peptide remains in circulation for
extended periods of time.
Rats administered liposomes via the intraperitoneal route in the
current PK study were observed for clinical signs over 72 hours and
results indicate that liposomal formulations would be well
tolerated over a wide dosing range (10-40 mg/Kg). These results
would be expected to provide a wide therapeutic index (the dosing
range between effective dose and the dose at which toxic effects
are seen) for drug administered by this route.
In the order of 250,000 new cancer cases annually in the US are
known to arise from cancers with origins in the peritoneal cavity.
Intraperitoneal injection is an attractive route to deliver
liposomal peptides to tumour sites for certain cancers, including
ovarian, pancreatic, colorectal, gastric and liver. While focusing
on ovarian cancer for definitive efficacy testing to provide proof
of concept for first clinical trial application, the Company
continues investigation and development of these liposomal peptides
in order to expand initial application to other cancer indications
for future marketing.
Dr. Ken Sokoll, Vice President of Clinical Development and Chief
Operating Officer for PharmaGap, commented "rapid metabolism and
elimination of peptide drugs is known to be a major factor
contributing to the failure of peptide drugs. Our ability to
overcome this problem using these new liposomal formulations and
demonstrating that we have viable formulations when administered by
both the intravenous and intraperitoneal routes will be key factors
in achieving success for our drug compounds."
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 effective in
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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