August 11, 2008
VitiGam(TM) Inhibits Melanoma Growth in a Dose Dependent Manner
GammaCan International, Inc. ("GammaCan" or "the Company") (OTCBB: GCAN), a developer of proprietary immunotherapies for the treatment of melanoma and other cancers, today announced further progress in its VitiGam(TM) development program. In preparation for its upcoming IND submission for VitiGam(TM), the Company successfully completed additional experiments using its established mouse melanoma model. These studies demonstrate a dose response of tumors (human melanoma cells) when treated with IgG preparations derived from vitiligo donors. In addition, the Company has conducted a meta-analysis (a statistical analysis of a large number of experiments) based on a series of previously announced studies with its mouse melanoma model. The results of this meta-analysis further confirm the effectiveness against melanomas of IgG preparations derived from vitiligo donors.
Using the A375 human melanoma cell line in SCID mice, the Company demonstrated that vitiligo-derived IgG preparations can prevent the growth of melanomas in a dose dependant manner. In these studies, mice with subcutaneously induced melanomas were treated with varying concentrations of vitiligo-derived IgG preparations and compared to saline treated mice. At higher doses, vitiligo-derived IgG preparations reduced tumor sizes by fifty percent and greater when compared to lower doses.The Company also conducted a meta-analysis to further confirm the overall effectiveness of vitiligo-derived IgG preparations against melanoma cells. This analysis revealed a specific and highly statistically significant inhibition of tumor growth in mice treated with vitiligo-derived IgG preparations. Specifically, the Company observed that two separate pools of vitiligo-derived IgG preparations were able to inhibit tumor growth in a highly statistically significant manner (p=0.006) compared to control mice receiving saline. In addition, this analysis substantiated that anti-melanoma effects are specific to vitiligo-derived IgG preparations. Tumors in mice treated with vitiligo-derived preparations were significantly smaller (p=0.043) when compared to tumors in mice treated with IgG preparations from non-vitiligo donors.
Steven Katz, Chairman of the Board and President of GammaCan said, "These analyses confirm the validity of our anti-melanoma program. Using our models, we have repeatedly demonstrated that vitiligo-derived IgG preparations can prevent tumor growth. Further, we have observed a dose response to vitiligo-derived IgG-based therapy." Mr. Katz further commented that, "These positive results continue to keep us on track to file our IND with the U.S. Food and Drug Administration in the near term."
GammaCan develops proprietary immunotherapy and related approaches to treat melanoma and other cancers. GammaCan's patented platform technology is based on the use of IgGs (gamma-immunoglobulins), a safe, relatively non-toxic human plasma-derived product used to treat a variety of immune deficiencies and autoimmune diseases. In cancer, IgG-based therapies work by strengthening the patient's immune system. Many experts currently view immunotherapy as a future alternative to chemotherapy. The Company's lead drug candidate, VitiGam(TM), targets Stage III and Stage IV melanoma for which no effective treatment currently exists. In August 2007, VitiGam(TM) received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of Stage IIB to Stage IV metastatic melanoma. For more information about GammaCan, visit www.GammaCan.com.
VitiGam(TM) is a first-in-class IgG-based anti-cancer immunotherapy being developed for the treatment of Stage III and Stage IV melanoma. GammaCan is planning to submit its Investigational New Drug Application (IND) for VitiGam(TM) to the FDA in the near future. The Company expects to commence human clinical trials shortly thereafter. VitiGam(TM) is an IgG-based product manufactured from the plasma of donors with Vitiligo, a benign skin condition affecting up to 2% of the general population. Studies have shown that this "enriched" IgG formulation contains potent anti-melanoma activity. Based on these studies, GammaCan expects VitiGam(TM) to provide specific anti-melanoma activity against melanoma cells, as well as non-specific anti-cancer activity.
Melanoma is a deadly form of skin cancer. According to the American Cancer Society, melanoma accounts for approximately 4% of all skin cancers but causes approximately 75% of all skin cancer-related deaths. An estimated 62,500 people will be diagnosed with metastatic melanoma (Stage III and Stage IV) in 2008; the prognosis is poor since no effective treatment currently exists. These patients have a median survival time of 8.5 months and a 5-year survival rate of less than 10%. There has been little change in these results for in excess of 25 years. The incidence of melanoma has increased more rapidly than any other cancer during the past 10 years. The last drug to treat patients with metastatic melanoma was approved by the FDA over 30 years ago.
Safe Harbor Statement
Statements in this press release that are not purely historical are forward-looking statements. Forward-looking statements in this press release include statements regarding: the commercialization of anti-cancer immunotherapies and the Company's efforts to develop therapies to boost the immune systems of cancer patients by the use of IgG-based therapy. Actual outcomes and the Company's actual results could differ materially from those in such forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as the inability to finance the planned development of the technology; the inability to hire appropriate staff to develop the technology; unforeseen technical difficulties in developing the technology; the inability to obtain regulatory approval for human use; competitors' therapies proving to be more effective, cheaper or otherwise preferable for consumers; the inability to market a product; all of which could, among other things, delay or prevent product release, as well as other factors expressed from time to time in GammaCan's periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with GammaCan's periodic filings with the SEC, which are incorporated herein by reference. The forward-looking statements contained herein are made only as of the date of this press release and GammaCan undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.