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GCAN Greater Cannabis Company Inc (PK)

0.0006
0.00 (0.00%)
26 Jul 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type
Greater Cannabis Company Inc (PK) USOTC:GCAN OTCMarkets Common Stock
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 0.0006 0.0006 0.0007 0.00 12:28:48

GammaCan Announces Positive Pre-IND Meeting with the U.S. FDA Regarding VitiGam - the Company's Novel Treatment for Metastatic

22/03/2006 12:30pm

Business Wire


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GammaCan International Inc. (OTC BB:GCAN), a developer of immunotherapies for the treatment of cancer and other diseases, today announced that the Company met with the U.S. Food and Drug Administration (FDA) on March 1st, 2006 to discuss requirements for the filing of an Investigational New Drug (IND) application for VitiGam, the Company's second generation investigational treatment for metastatic melanoma. GammaCan's scientists led by Prof. Yehuda Shoenfeld, M.D. have previously shown that plasma-derived IVIg has anti-cancer activity in a number of animal models. More recently, GammaCan has initiated an open label Phase II trial evaluating the anti-cancer properties of plasma-derived IVIg. This trial is expected to conclude later this year and data will be presented after it has been evaluated. GammaCan is planning to initiate human clinical trials with VitiGam, its second generation IVIg-anti-cancer product. GammaCan scientists have shown that plasma from donors with vitiligo, a benign condition affecting skin pigmentation, has anti-melanoma properties. Based on these and other findings, the Company recently held a pre-IND meeting with the FDA. "The meeting with the FDA is an important step towards getting VitiGam into the drug approval process," said Prof. Jacob Nusbacher, M.D., Director of Medical and Scientific Affairs for GammaCan. "GammaCan is very pleased with the meeting and received valuable input. We will be building on these discussions and plan to go forward with the development of VitiGam in order to seek FDA approval to initiate human clinical trials," Prof. Nusbacher concluded. About Vitiligo Vitiligo is a benign skin disorder affecting up to 2% of the population, or 40 to 50 million people worldwide. The condition is characterized by the loss of skin pigmentation due to the destruction of melanocytes, the skin's pigment-producing cells. Individuals with vitiligo are usually otherwise healthy and are able to donate blood or plasma. (Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institutes of Health Public Health Service -- U. S. Department of Health and Human Resources). About Melanoma Melanoma is a skin cancer caused by the uncontrolled growth of melanocytes. There are over 55,000 new melanoma cases in the United States each year, and the incidence of the disease is increasing. In about 15 to 20 % of patients the cancer spreads beyond the skin and invades lymph nodes followed by the spread to other organs often rendering surgical excision ineffective. Current therapies are only moderately effective with response rates in the 10% to 20% range. Most therapies also have severe side effects. (Source: The Melanoma Research Foundation and the American Cancer Society). About GammaCan: GammaCan is focusing on the commercialization of an innovative anti-cancer immunotherapy to treat metastatic cancer. GammaCan's platform is based on IVIg, a safe, relatively non-toxic human plasma-based product, currently used to treat a variety of immune deficiencies and autoimmune diseases. IVIg works by strengthening the patient's immune system. Many experts currently view immunotherapy as a future alternative to today's standard chemotherapy. GammaCan is developing VitiGam, its second generation program. VitiGam is an IVIg derived from the plasma of vitiligo donors and is being developed to treat malignant melanoma. GammaCan owns, and has applied for US patent protection covering the use of IVIg and vitiligo-derived IVIg (VitiGam). For more information about GammaCan visit www.GammaCan.com or call the company's headquarters in Givat Shmuel, Israel at 972 3 5774475 or toll free 1-866-308-0396 (from North America). Safe Harbor Statement: Statements in this document that are not purely historical are forward-looking statements. Forward-looking statements in this release include statements regarding: the commercialization of an anti-cancer immunotherapy and the Company developing the boosting of cancer patients' immune systems with IVIg into an effective treatment. 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, inability to hire appropriate staff to develop the technology, unforeseen technical difficulties in developing the technology, inability to obtain regulatory approval for human use, competitors' therapies proving more effective, cheaper or otherwise preferable for consumers, inability to market the product we produce, among other factors, all of which could among other things, delay or prevent product release or cause our company to fail. For further risk factors see the risk factors associated with other early stage medical research and development companies filed with the SEC on Edgar.

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