Aspen Park Pharmaceuticals acquires worldwide rights to APP-111 therapy from Ohio State University

Aspen Park Pharmaceuticals, Inc., a private company, today announced that it has acquired worldwide rights from The Ohio State University, through the Ohio State Innovation Foundation, to APP-111. APP-111 is a first-in-class oral, antitubulin targeting agent for the potential treatment for the form of castration resistant prostate cancer that does not respond or becomes resistant to currently available androgen receptor antagonists like XTANDI (enzalutamide) and testosterone reducing agents like ZYTIGA (abiraterone acetate and prednisone).

"It has now become clear that there is significant cross-resistance that occurs between androgen receptor antagonists (enzalutamide) and testosterone reducing agents (abiraterone) in men with metastatic castration resistant prostate cancer. So after a patient fails one of these drugs, a new drug with a different mechanism of action is required," said Dr. Mario Eisenberger, R Dale Hughes Professor of Oncology and Professor of Urology, The Johns Hopkins Hospital. "Cytotoxic agents that target tubulin remain the most effective agents against advanced prostate cancer, but currently they can only be administered IV and have significant side effects like neurotoxiticity and myelosuppression. An orally available agent, like APP-111, that targets tubulin would be expected to have activity against prostate cancer and would be an important addition to the armamentarium for treatment of castration resistant prostate cancer."

APP-111 is an orally available tubulin targeting agent that has demonstrated efficacy in preclinical studies against hormone sensitive, castration resistant, as well as taxane resistant prostate cancer. Further, in preclinical studies, it appeared to have less peripheral neurotoxicity and myelosuppression than currently available antitubulin cytotoxic agents. This high potency, small molecule drug binds to microtubules and prevents polymerization which has been shown to not only block cell division and induce cell death, but also disrupts androgen receptor signaling required for tumor growth. Since microtubules are involved in the transport of the androgen receptor to the nucleus, agents that target microtubule interactions with the receptor have the potential to serve an important therapeutic role in treating advanced prostate cancer. APP-111 is expected to be in Phase1a/1b clinical studies in late 2016. APP-111 has over 21 issued, allowed, and pending patents. These patents also cover hundreds of potential analogue back-ups across multiple structural templates. APP-111 is a platform technology that may have activity in other tumor types that have previously responded to taxanes or vinca alkaloids.

"We are pleased to acquire the rights to APP-111 and its analogues. APP-111 has tremendous possibilities and value. We are committed to develop APP-111, a novel therapy, initially for men with advanced prostate cancer," said Harry Fisch, MD, Chairman of Aspen Park Pharmaceuticals, Inc.