Moleculin Gets Clearance for WP1066 IND

Moleculin Biotech (NASDAQ:MBRX) announced it received a clearance from the US Food and Drug Administration (FDA) for their physician-sponsored Investigational New Drug (IND) application for a Phase I trial of Moleculin’s drug WP1066 in patients with recurrent malignant glioma and brain metastasis from melanoma.
As quoted in the press release:

“We are so pleased to now have a second drug enter the clinical stage,” commented Walter Klemp, Chairman and CEO of Moleculin. “We believe WP1066 represents a new class of anticancer drugs able to fight tumors on two fronts by directly inhibiting cell signaling supporting tumor activity, and independently stimulating a natural immune response. This constitutes a new approach to treating brain tumors and tumor metastasis to the brain.
Mr. Klemp concluded, “Since the discovery of WP1066 at MD Anderson by Prof. Waldemar Priebe, it has now been studied by many independent groups and is widely recognized as a potent inhibitor of the activated form of a protein called STAT3, which has been implicated in many difficult to treat tumors, including brain tumors. Animal studies have shown that inhibition of STAT3 directly blocks tumor proliferation and its survival, while most importantly boosting the immune system’s ability to fight cancer. We finally have our first opportunity for a clinical proof of concept and confirmation of promising preclinical activity.”

Click here to read the full press release.

Source: www.marketwired.com