Greater Cannabis (PK) (USOTC:GCAN)
Historical Stock Chart
From Dec 2019 to Dec 2024
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.