PharmaGap Updates Lead Drug Status and Potential Sale
June 05 2012 - 8:30AM
PR Newswire (Canada)
OTTAWA, June 5, 2012 /CNW/ - PharmaGap Inc. (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 these results. 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 trials. 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. , 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. PHARMAGAP INC. CONTACT: Sharilyn
McNaughton (613) 287-3124
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