PharmaGap Announces Successful Completion of Liposomal Development With Significantly Improved Potency of Cancer Drug
September 12 2011 - 7:27AM
Marketwired
PharmaGap Inc. (TSX VENTURE: GAP)(OTCBB: PHRGF) ("PharmaGap" or
"the Company") today announced that it has successfully completed
the design, development, manufacture and testing of a liposome
formulation of both basic and enhanced versions of its lead cancer
drug GAP-107B8, and will proceed to in vivo testing of both
formulations in bladder and ovarian cancer models in order to
select one formulation and cancer target for first human clinical
trials. This in vivo testing will be undertaken between now and the
end of 2011, with a final selection based on the results seen in
these tests.
This development program has involved the production of a number
of prototype designs, each at a range of drug concentrations within
the liposome carrier. These prototypes were tested for potency
across a 3 human bladder cancer and 3 human ovarian cancer cell
lines, and compared head to head with the GAP-107B8 peptides alone
(basic and enhanced versions), and with the empty liposome
carriers. This testing was carried out at PharmaGap labs over the
past 6 months. The liposome formulations and the enhanced version
of GAP-107B8 represent novel and material new intellectual property
for PharmaGap, and is the subject of a patent filing for the
Company.
Dr. Ken Sokoll, Vice President of Clinical Development and Chief
Operating Office for PharmaGap, stated "I am very pleased that we
have achieved our objective of successfully identifying a liposomal
formulation of both versions of our lead cancer drug, in the time
frame established when we embarked on this program in the first
quarter of the year. We now are presented with the prospect of a
widened therapeutic window, and are seeing in vitro effectiveness
at dose ranges suitable to proceed to human clinical trials. This
has been a very labour intensive effort both internally by our
staff as well as at our contractor sites, and I want to thank each
of them for a high degree of effort and diligence in arriving at
this key point in our program."
The successful development of the liposomal formulations of
basic and enhanced GAP-107B8 has significantly widened the
GAP-107B8 Therapeutic Window (the range of doses between the lowest
effective dose and the highest dose where unacceptable toxicity
become evident), which is a key consideration for effective
clinical trial design and ultimate success of the drug in the
marketplace.
Liposomal delivery systems are an accepted, proven, and
commercially viable strategy for the formulation of pharmaceuticals
for clinical use. These delivery systems are employed to improve
tumour targeting, modulate the pharmacokinetics of the active agent
and enhance its stability following administration. Therapeutic
activity may be improved by modulating drug exposure and
accumulation (controlled release) in the region where the target
cells are located.
The two formulated GAP-107B8 compounds will now both proceed
through in vivo pharmacokinetic and pharmacodynamic testing (to
assess physical characteristic of the drug in a live system), as
well as the determination of Maximum Tolerated Dose, in order to
determine the optimum dose ranges for use in the in vivo efficacy
testing of both formulations in bladder cancer (using intravesical
administration) and ovarian cancer (using intraperitoneal
administration) in the 4th quarter of this 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.
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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