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PharmaGap Inc. (GAP) Reports Early Results in Bladder Cancer; Announces Collaboration With Queen’s University to Pursue Development for Clinical Use  
12/21/2010 9:36:57 AM

OTTAWA, ONTARIO--(Marketwire - December 21, 2010) - PharmaGap Inc. (TSX VENTURE: GAP)(OTCBB: PHRGF) ("PharmaGap" or "the Company") is pleased to announce a collaboration with Queen's University at Kingston, Ontario ("Queen's") to investigate the potential for development of PharmaGap's lead cancer drug GAP-107B8 in bladder cancer. In recent tests in PharmaGap's development labs, PharmaGap has shown the effectiveness of GAP-107B8 in limiting growth of three human bladder cancer cell lines representative of transitional cell carcinomas of varying degrees of malignancy (e.g. grade I, II, and III tumours).This is the first instance whereby testing of GAP-107B8 in bladder cancer has been explored. Estimates for 2010 report 77,630 new cases of bladder cancer and 16,530 deaths (U.S. National Cancer Institute and Canadian Cancer Society figures). Current therapeutic options in bladder cancer are limited.

Bladder cancer is an attractive initial cancer target for GAP-107B8 using intravesical route of administration. Intravesical administration represents a non-systemic route of delivery, which permits more direct targeting of bladder cancer tumours within the bladder, compared with systemic delivery which is less well targeted and has higher possibility of unwanted toxicity at the required dose levels. As a result, dosing levels can be better refined in order to mitigate any sensitivity issues.

The initial phase of work at Queens is designed to enable investigators to design and deliver a subsequent in vivo study to determine the Maximum Tolerated Dose (MTD) and efficacy of GAP-107B8 in a murine bladder cancer model using intravesical infusion. Intravesical infusion is a recognized, clinically-acceptable method of drug administration for bladder cancer which entails the direct injection and retention of the drug for a period of time directly in the bladder for uptake by the affected membrane.

Test programs are currently underway at Queen's (bladder cancer), Ottawa Hospital Research Institute ("OHRI") (ovarian cancer), Memorial Sloan-Kettering Cancer Center of New York, NY. (" MSKCC") (melanomas and sarcomas), and internally at PharmaGap in conjunction with a number of external contract research organizations. These programs are designed to provide the Company with the basis for selection of the optimal cancer target and route of administration for human clinical trials. The selection of cancer target is based on numerous factors including efficacy of the drug, identification of the best route of administration to deliver the drug to the target within safe dose limits, final formulation of the drug and any excipients to aid in safe and effective delivery, and current best standard of care in clinical use for the selected cancer target.

All studies are directed by Dr. Ken Sokoll, Vice President Clinical Development and Chief Operating Officer for PharmaGap. Principal Investigators are Drs. Charles Graham and Robert Siemens at Queen's, Dr. Barbara Vanderhyden at OHRI and Dr. Gary Schwartz at MSKCC.

In commenting on the program, Dr. Sokoll observed "We are pleased that Dr. Charles Graham and Dr. Rob Siemens of Queens University will be assisting our efforts to develop GAP-107B8 for the treatment of bladder cancer. We anticipate that positive results from this collaboration will facilitate the selection of the preferred cancer target and route of administration for clinical development of GAP-107B8 and enable discussions directed towards licensing with pharmaceutical companies."

Dr. Charles Graham is Professor and Head of the Department of Anatomy and Cell Biology at Queen's University with cross-appointments in the Department of Pharmacology and Toxicology and the Department of Urology. After completing his doctoral studies at the University of Western Ontario and a post-doctoral fellowship at Sunnybrook Health Science Centre in Toronto he joined Queen's University in 1994.

Cancer research in Dr. Graham's laboratory focuses on the biology of malignant progression. Studies from his group have uncovered a novel mechanism by which the local tumour microenvironment, and in particular hypoxia, contributes to drug resistance, metastasis, and immune escape in cancer cells. Specifically, his research has shown that malignant adaptations to hypoxia are closely linked to nitric oxide signalling. This finding has led to the development of new modalities for the treatment of prostate cancer, which are currently under investigation in clinical trials.

Dr. Rob Siemens graduated from Medicine and subsequently completed his Urology Residency at Queen's University in 1997. He received a McLaughlin Fellowship to study Oncology at the University of Iowa. Since 2006, he has held an appointment as Associate Professor to the Department of Urology, with a cross-appointment to the Departments of Oncology and Anatomy and Cell Biology at Queen's University where his research interests include investigation into mechanisms of treatment resistance in prostate and bladder cancer, as well as quality indicators of cancer care.

Dr. Siemens has published over seventy peer-reviewed articles and book chapters and participates in numerous national and international consensus meetings. He has received research grants and scholarships from organizations such as the CIHR, US Department of Defense, American Urological Association, Canadian Cancer Society, and the Canadian Urologic Association. Dr. Siemens has recently been a member of the Urology Examination Board and Test Committee at the Royal College of Physicians and Surgeons in Canada. He was also the recipient of the 2005 Canadian Medical Association Leadership Award and a member of the 2008/2009 AUA Leadership Program.

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.

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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