PharmaGap Reports Significant Improvement in Efficacy of Enhanced GAP-107B8; Early Results of Testing in Bladder Cancer
15 June 2011 - 10:00PM
Marketwired
PharmaGap Inc. (TSX VENTURE: GAP)(OTCBB: PHRGF) ("PharmaGap" or
"the Company") today reports significant improvement in efficacy
using an enhanced version of its lead cancer drug GAP-107B8, along
with a further update on progress toward clinical trials.
The Company has tested an enhanced version of GAP-107B8 and is
seeing significantly increased efficacy for this unformulated
peptide at lower doses from in-vitro and early in vivo results.
The Company has previously reported that using a liposomal
formulation will permit it to achieve improved efficacy and widen
the safety window for its lead drug GAP-107B8 in its original form.
A liposomal formulation of the enhanced peptide is currently being
produced, with testing to follow in Q3. The combination of these
two initiatives is expected to significantly broaden the
Therapeutic Index for GAP-107B8 - the separation of effective dose
from the higher doses at which toxicity appears - a key
consideration for a successful clinical trial design. Selection of
the final peptide form and liposomal formulation to advance into
efficacy studies is expected to be made in Q3 2011.
Robert McInnis, President and C.E.O. of the Company, commented
that "The program that we have undertaken over the course of the
past 9 months and which will continue to completion this year to
enhance efficacy and safety of our lead drug compound will provide
us with a significantly higher probability of approval of the
clinical trial application and success in clinical trials. The
short delay in the anticipated filing for clinical trial approval
from Q3 2012 to Q4 2012, necessitated by this drug enhancement and
formulation effort, will be more than offset by a much higher
probability of success. Under the leadership and direction of our
clinical development program by Dr. Ken Sokoll, and the work
completed since his appointment as Vice President Clinical
Development and Chief Operating Officer in September 2010, we are
now provided with a much enhanced capability to meet the
requirements to achieve clinical trial success, and accordingly a
much higher degree of confidence in our ability to submit the
clinical trial application by Q4 of 2012."
Other program elements
Work is underway at the Company's current manufacturer of
peptide in order to optimize and scale-up the production of peptide
that will proceed to cGMP ("current Good Manufacturing Practice")
production of the peptide.
The Company has also received first results of testing in
bladder cancer cell lines at a collaborator site. The early
findings from in-vitro Colony Forming Assays ("CFA") in tumour
cells has demonstrated that unformulated peptides can significantly
reduce the survival of colonies in the two murine bladder cancer
cell lines studied. The early results from this study have also
demonstrated that the enhanced GAP-107B8 peptide is more potent at
lower concentrations. CFA assays provide useful information
relevant to clinical development including the efficacy of the drug
compound against cancer cells that metastasize and
therapy-resistant cells that have the ability to re-populate
tumours. Full details of these results will be announced when
complete results are received and analyzed by the Company.
The Company is currently in contract discussions with an
independent Contract Research Organization to expand and accelerate
the investigation of liposomal formulations and unformulated
versions of GAP-107B8 in in vivo models of bladder cancer, and
expects to be able to start this program in early Q3 2011.
Additional in vivo studies in ovarian cancer models will take place
in Q3/Q4 using liposomal formulations of GAP-107B8 peptides.
Results of this testing will be critical to the choice of final
formulation of GAP-107B8 and the cancer target to proceed to
clinical trials.
With the significance and extent of new data generated,
specifically with respect to peptides and liposomal formulations,
the Company is developing and filing additional patents in order to
generate new and valuable Intellectual Property Rights for its lead
cancer drug program.
Discussions have commenced and will continue through 2011 with
Clinical Trial Contract Research Organizations. Past performance in
accruing patients for bladder and ovarian cancer trials and access
to key oncology leaders in these cancers will be a key determining
factor in this selection, to be made in early 2012.
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: Robert McInnis, President & CEO (613) 990-9551
bmcinnis@pharmagap.com
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