December 15, 2004 08:00 AM US Eastern Timezone
ArTec, Inc. Completes Protocol for Phase I b Study of Tubercin
RENO, Nev.--(BUSINESS WIRE)--Dec. 15, 2004--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.
Forward-looking statements in this press release, the company cautions the investors, involve risks and uncertainties pursuant to the "Safe Harbor" provisions of the Private Securities Litigation Reform Act of 1995. In addition, the company cautions investors that it undertakes no obligations or responsibilities to publicly update these forward-looking statements to reflect Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated
