OTTAWA, June 5, 2012 /CNW/ - PharmaGap Inc. (TSXV: GAP) (OTC.BB: PHRGF)
("PharmaGap" or "the Company") today provides an update on the current
developmental status of its lead drug program.
Animal studies completed in January 2012 tested the PharmaGap drug
formulations in head to head comparisons against Carboplatin using
ovarian cancer cell lines OCC-1, A2780cp, and ES-2 implanted into mouse
subjects. These tests indicated GAP-107B8 reduced malignant ascites up
to 88% compared to the Carboplatin control at 42%. Tumour burden was
reduced by 62% in the OCC-1 model using GAP-107B8 compared with
Carboplatin control at 72% reduction. The company expects that future
test protocols in animals with refined dosing schedules can improve on
However, while the test results provided strong indications of efficacy
for the GAP-107B8 formulations, conditions of the control groups within
the test were inadequate to generate statistical significance. To file
for Clinical Trial Approval, the Company must repeat efficacy studies
to demonstrate a statistically significant effect of the final lead
drug product. The Company must produce clinical-grade drug product in
amounts sufficient to complete final toxicology testing. For clinical
trials the Company must generate and compile data and documents
required for the application and make arrangements with clinics in
Canada and the US and contract research organization to implement the
Several significant investment funds invest only in private companies at
this stage of development. As a public company, PharmaGap receives 10%
cash refund of eligible R&D expenses under the Ontario SR&ED Program.
These costs, if incurred by a private company, would receive 41.5%
total cash refund under Federal and Ontario SR&ED Programs. Taken
together, these factors indicate the sale of the lead drug by PharmaGap
to a private company under satisfactory terms will provide enhanced
value to PharmaGap shareholders. An Independent Committee of the Board
of Directors of PharmaGap has concluded that the highest value
potential for its lead drug technology can now be realized under the
licensing proposal from Clinical Value Corporation ("CVC") the details
of which were recently announced to the market.
The Board of Directors has accepted the recommendation of the
Independent Committee for approval of the CVC proposal subject to
receiving a fairness opinion and advice of independent legal counsel.
(Mr. Bryden, who initially owns 100% of CVC and is Chairman of
PharmaGap declared his interest in the transaction and did not
participate in the deliberation or vote of the Board). Following
receipt of the fairness opinion, the proposal shall be presented to and
will be subject to a vote by shareholders excluding shares controlled
by Mr. Bryden.
Under the CVC proposal, CVC will be granted a right of first refusal on
any newly developed pipeline products (i.e. outside of the licensed
technology) generated by PharmaGap in the future, representing
additional potential value for PharmaGap shareholders. Under the CVC
proposal, CVC will provide financial support for the pipeline research
for a three year period at the rate of up to $40,000 per month.
About PharmaGap Inc.
PharmaGap Inc. (TSX-V: 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
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.
SOURCE PHARMAGAP INC.
For further information:
Sharilyn McNaughton (613) 287-3124