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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™ development
program. In preparation for its upcoming IND submission for VitiGam™,
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.”
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 62,500 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.