Hard to Treat Diseases (HTDS)

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ArTec completes phase Ib Tubercin protocol
ArTec Inc has reported that an FDA specialist hired by the company has completed the protocol for the FDA phase Ib human study designed to evaluate the efficacy and safety of anticancer treatment Tubercin in melanoma patients.

ArTec Inc has reported that an FDA specialist hired by the company has completed the protocol for the FDA phase Ib human study designed to evaluate the efficacy and safety of anticancer treatment Tubercin in melanoma 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. ArTec's management intends to submit the study to an institutional review board of the FDA for the approval.

"The completion of this carefully crafted protocol is the most significant step we have taken toward the process of gaining US FDA approval for our revolutionary compound," noted Dr Chung, scientific advisor of ArTec and inventor of Tubercin.

"Tubercin in the past has been used only on a compassionate care basis outside the US. It is important that we be proactive in moving our agenda forward to broaden the availability of this compound to suffering people in the US."

ArTec is currently seeking an executive director from a leading oncology research institute that will oversee this phase Ib study. The company anticipates that the approval process will take several weeks, after which it intends to conduct the study at a prominent cancer hospital in the US.


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