GammaCan Receives FDA Orphan Drug Designation for Lead Product VitiGam(TM) for Stage IIB to Stage IV Melanoma
August 07 2007 - 8:39AM
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 its lead anti-cancer
immunotherapy, VitiGam�, has received Orphan Drug designation by
the U.S. Food and Drug Administration (FDA) for the treatment of
Stage IIB to Stage IV metastatic melanoma. GammaCan anticipates
filing an IND with the FDA for a Phase I/II clinical trial by
year-end, and initiate clinical testing of VitiGam� in early 2008.
Orphan Drug designation entitles GammaCan to exclusive marketing
rights in the United States for VitiGam� for up to seven years
should GammaCan be the first company to receive marketing approval
for this therapeutic drug product. Under the Orphan Drug Act (ODA),
the FDA will not accept or approve other applications from other
sponsors to market an identical medicinal product for the same
therapeutic indication for the seven-year period. In addition, the
designation allows GammaCan to apply for a waiver from the FDA of
certain filing and user fees required by the Prescription Drug User
Fee Act (PDUFA). Steven Katz, Chairman of the Board and President
of GammaCan said, "We are very encouraged that the FDA has granted
VitiGam� Orphan Drug designation. This will afford GammaCan
additional protection in marketing VitiGam� once we are granted
approval. This designation highlights the acute need for new
therapies to treat metastatic melanoma.� Jacob Nusbacher, M.D.,
Director of Medical and Scientific Affairs, commenting on this
designation said, �We look forward to working with the FDA as we
would like to make VitiGam� available for all Stage IIB to Stage IV
metastatic melanoma patients as quickly as regulators will allow,
particularly since these patients have very limited available
options for treatment.� About the Orphan Drug Act The Orphan Drug
Act (ODA) provides for granting special status to a product to
treat a rare disease or condition upon request of a sponsor. The
combination of the product and the rare disease or condition must
meet certain criteria. This status is referred to as orphan
designation. Orphan designation qualifies the sponsor of the
product for tax credit and marketing incentives of the ODA. A
marketing application for a prescription drug product that has been
designated as a drug for a rare disease or condition is not subject
to a prescription drug user fee unless the application includes an
indication other than the rare disease or condition. About GammaCan
GammaCan develops proprietary immunotherapy and related approaches
to treat melanoma and other cancers. GammaCan's platform patented
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 lll and Stage lV melanoma for
which no effective treatment currently exists. 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 both,
specific anti-melanoma activity (directed against melanoma cells),
and 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 will be diagnosed with and nearly 8,000
people will die 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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