ArTec, Inc. Completes Protocol for Phase I b Study of Tubercin
RENO, Nev., Dec 15, 2004 (CCNMatthews via COMTEX) -- ArTec, Inc. (Pink
Sheets:ATKJ) announced today that Nancy Angus, an FDA specialist hired by ArTec,
Inc., has completed the protocol for the FDA Phase I (b) Human Study designed to
evaluate the efficacy and safety of Tubercin in certain cancer patients. This
study is directed toward adult subjects who are suffering from metastatic Stage
IV melanoma who cannot be treated by surgery, and will include approximately 30
people between the ages of 18 and 65. The study, designed to be conducted over a
42-day period, will evaluate the administration of Tubercin alone, as well as in
conjunction with other established Immunotherapy treatments such as Interleukin,
Alpha Interferon and Granulocyte Stimulating Macrophage-Colony Stimulating
Factor. The results of the study will be evaluated and measured for decreases in
mass of tumors, improved clinical signs in patients and relief of pain.
Management intends to submit the study to an Institutional Review Board of the
FDA for the approval.
Dr. Chung, scientific advisor of ArTec and inventor of Tubercin noted, "The
completion of this carefully crafted protocol is the most significant step we
have taken toward the process of gaining United States FDA approval for our
revolutionary compound." He further added, "Tubercin in the past has been used
only on a compassionate care basis outside the U.S. It is important that we be
proactive in moving our agenda forward to broaden the availability of this
compound to suffering people in the U.S. We must create an image of wellness for
cancer victims that Tubercin is a viable option to consider."
ArTec is seeking an executive director from a leading oncology research
institute that will oversee this Phase 1 (b) study. Management anticipates that
the approval process will take several weeks, after which it intends to conduct
the study at a prominent cancer hospital in the United States.
CONTACT: ArTec, Inc., Reno
Gerry Knight, 800-388-8875
www.artec-inc.net
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