OTTAWA, ONTARIO--(Marketwire - Jan. 27, 2011) - PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB:PHRGF) ("PharmaGap" or "the Company") is pleased to provide guidance to stakeholders on progress toward clinical trials.
Through the first half of 2011, PharmaGap's clinical development program is focused on testing and development activities in order to provide the Company with the basis for selection of the initial cancer target for clinical trials. This decision will be based on three key factors:
- Test results obtained against specific cancer targets using GAP-107B8 and variants, and the observed behavior of the drug using the different routes of administration commonly found in the clinic for the cancer indications under investigation
- The absence of or deficiencies in current standard of care
- Any accelerated approval programs available for the selected cancer type
Tests to date have shown efficacy in treatment of a range of cancers. Bladder cancers using intravesical administration, and ovarian cancers using intraperitoneal administration are being assessed as potential first candidates for clinical trials. Both routes of administration are recognized as viable clinical delivery methods for the applicable cancer type.
PharmaGap's prime objective in the first half of this year is to select the single cancer target and clinical formulation of GAP-107B8 that will provide the Company with the best opportunity for successful completion of all regulatory requirements to be met in order to commence clinical trials in the first half of 2012.
Key activities underway to support this decision include in vitro and in vivo testing of GAP-107B8 at collaborator sites previously announced, as well as a range of in vitro testing at PharmaGap characterizing candidate dosage forms intended for use in in vivo tumour model studies and subsequent human trials.
Bioanalytical, pharmacokinetic, and toxicology profiling for both intraperitoneal (for ovarian) and intravesical (for bladder) delivery systems has commenced and will be ongoing through the first half of 2011, both internally and at contract research organizations.
Formulation work, which is underway, includes investigation into the effect of excipients to the core active pharmaceutical ingredient ("API") that is central to GAP-107B8's activity, as well as to investigation and development of the final dosage form of product for use in humans. This formulation work has as its principal objective the delivery of the most efficacious dose of GAP-107B8 to the site of the chosen cancer target, with maximum uptake of the drug into the tumour vasculature, while promoting stability and minimizing any potential side effects. Also during this period discussions will continue with peptide manufacturers with cGMP production capabilities for GAP-107B8 with the objective of selecting a peptide manufacturer for production of GAP-107B8 for clinical use.
Following the selection of cancer target and determining the preferred route of administration of the dosage form for first clinical trials, the Company will proceed with the generation of all data required in order to meet the non-clinical regulatory requirements in Canada and the United States to apply for approval for the first clinical trial for GAP-107B8.
Dr. Ken Sokoll, Chief Operating Officer and Vice President Clinical Affairs, expressed confidence with the position of PharmaGap and the advancement of the program toward clinical trials: "The program to move our peptide into clinical trials is demanding but achievable. Each of the cancer types now being assessed has significant incidence and unsatisfactory treatment alternatives. It is exciting and rewarding to lead this program that holds promise of bringing to trials a potentially significant new treatment choice for patients" Dr. Sokoll said.
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.