GammaCan Executes Supply Agreement with Bio Products Laboratory to Manufacture VitiGam(TM) for the Treatment of Melanoma for Cli
June 04 2008 - 9:02AM
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 that the
Company�s subsidiary has entered into a comprehensive manufacturing
agreement with Bio Products Laboratory ("BPL") to produce the
Company�s lead drug candidate, VitiGam�, from plasma derived from
Vitiligo donors. BPL is a division of National Health Service Blood
and Transplant, a unit of the United Kingdom National Health
Service. BPL is a leading manufacturer of plasma-based products
distributed worldwide. Under the terms of agreement, BPL will
manufacture VitiGam� utilizing its proprietary GAMMAPLEX process.
The multi-year agreement provides for the supply to GammaCan of
VitiGam� for the Company's immediate clinical testing needs and for
future commercial sale. In addition, the agreement provides that
BPL will provide the Company with technical, scientific and other
data, including specific support for its U.S. regulatory filings
and future regulatory approvals in other markets. While specific
financial terms will not be disclosed, the agreement provides that
BPL will produce VitiGam� for clinical testing and future
commercial sale at market-based prices. The Company will purchase
related services, when required, also at agreed upon and
market-based pricing. Steven Katz, Chairman of the Board and
President of GammaCan said, "Our ability to enter into a supply
contract with a market leader such as BPL constitutes further
validation of our technology. Securing a manufacturer of VitiGam�
for our clinical testing program is also one of the last major
steps needed to assure our ability to submit an IND with the U.S.
FDA in the near-term." Andrew Williams, Sales and Marketing
Director for BPL, commented, "GammaCan's manufacturing requirements
can be readily integrated with our capabilities. This new
relationship with GammaCan will enable us to participate, at an
early stage, in a most promising and exciting commercial
opportunity." 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 BPL
BPL is located in Elstree on the outskirts of London. BPL processes
human plasma (sourced from U.S. donors) through to a range of
highly purified and safe plasma products, including intravenous
immunoglobulin (IVIG), albumin, Factor VIII and Factor IX. BPL
invests in the latest research, technology and manufacturing
methods and is committed to provide a continuous and competitive
supply of high quality plasma-derived products to the United
Kingdom and a growing global market. For more information about
BPL, visit www.bpl.co.uk. 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.
Greater Cannabis (PK) (USOTC:GCAN)
Historical Stock Chart
From Nov 2024 to Dec 2024
Greater Cannabis (PK) (USOTC:GCAN)
Historical Stock Chart
From Dec 2023 to Dec 2024