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Shares of Junior Drug Maker Rise as Clinical Trials for Ovarian Cancer Drug Draw Closer
By: AllPennyStocks.com News
November 25, 2011
Heading towards clinical trials is a major step for developmental biotechnology firms. While pre-clinical research can often be scoffed out by investors who only see value in biotechs that are later-stage or already producing revenue, to those who lean towards the speculative side of investing, the data can be exhilarating and provide promise for the future.
PharmaGap Inc. (TSX-Venture:GAP) (OTCBB:PHRGF) is buttoning-up its pre-clinical research in preparation for clinical trials. The Company is researching its GAP-107B8 drug as a new indication for ovarian cancer. According to data from the American Cancer Society, 21,990 new cases of ovarian cancer will be diagnosed in 2011 and 15,460 women will die of the dreaded disease in the United States. PharmaGap has reported that GAP107B8 is a potential target for many different cancers, including pancreatic, colorectal, gastric and liver, but its initial focus will be as a new therapy for ovarian cancer.
Last week, PharmaGap commenced an in vivo efficacy study using human ovarian cancer in validated mouse models. Maximum Tolerated Dose Study was also completed and reported. With its latest mouse model research, PharmaGap is hoping to validate similar ovarian cancer mouse models using non-liposomal formulations of GAP-107B8 which showed reduced tumor burden of 19 percent and a significant suppression of malignant ascites formation of 73%. Malignant ascites is a significant cause of morbidity in women with ovarian cancer, and is also present in other forms of cancer as well as being associated with increased level of metastases of many cancers. The study is slated to be concluded in December with analysis of the data to be disclosed in January 2012.
Today, the dually-listed biotech announced that, in rat studies, liposomal formulations of GAP-107B8 have proven to meet and surpass expectations for potency, pharmacokinetic profile and therapeutic index, three key elements important for clinical trials. Again, the drug is showing statistical significance with peptide half-life increasing from a range of 0.4 to 0.7 for unformulated peptides to approximately 8 hours using intravenous administration and to approximately 40 hours using intraperitoneal administration (meaning that the injection is placed with the abdomen space containing the intestines, stomach and liver). Liposomal associated peptide was detectable up to 72 hours post administration indicating that peptide remains in circulation for extended periods of time. Detectability after 72 hours indicates tolerability over a wide dosing range and boosts expectations about providing a wide therapeutic index for drugs administered via intraperitoneal injection.
The need is great for novel therapies to be developed to address virtually all forms of cancer given the high death rates associated with cancer and the ever-growing tendency of drugs developing a strong resistance towards today’s drugs. PharmaGap is still early in development with its new drug, but showing very promising results which encourage further development. Biotech investors will soon be honing in on this junior drug maker seeking information on sponsorship of clinical trials to take GAP-107B8 to the next level, a level that attracts a lot more attention from the investment community. Trading in the area of 7 cents per share, proper due diligence could potentially lead to nice rewards in the mid-term.
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