GammaCan Announces Positive Pre-IND Meeting with the U.S. FDA Regarding VitiGam - the Company's Novel Treatment for Metastatic
March 22 2006 - 7:30AM
Business Wire
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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