GammaCan Announces Positive Testing Results in the Development of VitiGam(TM) for the Treatment of Melanoma
March 06 2008 - 1:12PM
Business Wire
GammaCan International, Inc. (�GammaCan� or �the Company�) (OTCBB:
GCAN), a developer of proprietary immunotherapies for the treatment
of melanoma and other cancers, today announced progress in its
VitiGam� development program. During the last several months, the
Company has completed a series of significant animal experiments
confirming the effectiveness of IgG preparations derived from
vitiligo donors against melanoma cells. This is the basis for
GammaCan�s lead product, VitiGam�. In a number of human melanoma
model experiments, using SCID mice and the A375 human melanoma cell
line, the Company demonstrated that vitiligo-derived IgG
preparations can prevent, in a statistically significant manner,
the growth of subcutaneous melanomas (tumors). In these
experiments, IgG preparations derived from vitiligo donors were
compared to a variety of other IgG preparations and also compared
to saline. These experiments further demonstrate that IgG
preparations derived from vitiligo donors also achieved, in a
highly statistically significant manner, a reduction in the tumor
size of small tumors. Steven Katz, Chairman of the Board and
President of GammaCan said, �Our data are highly encouraging in
that they demonstrate, for the first time, in human melanoma
models, anti-melanoma activity from IgG preparations derived from
vitiligo donors.� Mr. Katz further commented that, �These positive
results keep us on track to file our IND with the U.S. Food and
Drug Administration in the near term.� About GammaCan 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�, targets Stage III and Stage IV melanoma for which no
effective treatment currently exists. In August 2007, VitiGam�
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. About VitiGam� VitiGam� 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� to the FDA in the near future. The Company expects to
commence human clinical trials shortly thereafter. VitiGam� 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� to provide specific anti-melanoma
activity against melanoma cells, as well as non-specific
anti-cancer activity. About Melanoma 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
62,000 people were diagnosed with and nearly 8,000 people died from
melanoma in the U.S. alone in 2007. If rapidly diagnosed and
surgically removed, early-stage melanoma is usually curable.
However, for patients with metastatic melanoma (Stage III and Stage
IV), 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.
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