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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.