Moleculin hires Theradex to help run its clinical AML study

Moleculin Biotech is in talks with the FDA to start its trial in AML.

Texas-based Moleculin Biotech penned a deal with Theradex Systems to help it run early-stage trials for its candidate annamycin in acute myeloid leukemia (AML).  

The New Jersey-based CRO is slated to help with phase 1/2 for the drug, an anthracycline intended for the treatment of relapsed or refractory AML, after the biotech has finished talks with the FDA for its IND (and, of course, if the agency signs off on the test).

Walter Klemp, chairman and CEO of Moleculin, said: “We are pleased to announce this key milestone. We selected Theradex for their extensive U.S. and international expertise with clinical research and development of pharmaceutical compounds in the areas of oncology and life-threatening diseases, including considerable experience with AML.

“Engaging Theradex is a key step in preparing to initiate our phase 1/2 clinical trial for annamycin and we look forward to moving ahead with them as we continue to work with the FDA on our IND, which must go into effect for clinical trials to begin. We are confident in Theradex’s ability to assist us in executing a high-quality and efficient trial.”

Annamycin works as a liposome formulated anthracycline that is designed to lower the risks of cardiotoxicity (which can cause severe heart damage), while also avoiding the multidrug resistance mechanisms, where cancer cells begin to recognize the anthracycline as a foreign agent to the body and pump it out before the cancer can be killed.

The drug has come out of work at the MD Anderson Cancer Center. The biotech also has two preclinical small molecule portfolios, one of which is focused on the modulation of tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.