Panavance Therapeutics is gearing up to submit an Investigational New Drug (IND) application to the FDA for misetionamide (GP-2250), a tumor cell-selective small molecule drug, targeting platinum-resistant ovarian cancer (PROC). The planned clinical trial will evaluate misetionamide in combination with bevacizumab and pegylated liposomal doxorubicin (PLD). This initiative follows promising preclinical results and a successful pre-IND meeting with the FDA in May.
Clinical Development Plan
Misetionamide has shown preliminary success in treating pancreatic cancer. A study published in "Cancer Medicine" demonstrated a profound antitumor effect when used as a monotherapy and synergistically with PARP inhibitors or bevacizumab in preclinical models. The drug also exhibits anti-angiogenic activity, enhancing its interaction with bevacizumab. These findings support further investigation of misetionamide in combination with PARP inhibitors or bevacizumab as a novel antitumor drug combination for ovarian cancer.
FDA Engagement and Trial Design
According to Panavance CEO Greg Bosch, the pre-IND meeting with the FDA was crucial in refining the clinical development plan for a Phase 1/2/3 trial. The meeting provided clarity on structuring the initial new drug application and preparing for the Phase 1 study. Key discussions focused on inclusion/exclusion criteria, particularly prior treatments eligible patients may have received before enrolling in the trial.
The company is diligently preparing the details of the clinical trial sites, including informed consent documents, pharmacy protocols, blood draw sample protocols, testing, and lab guidance documents, alongside finalizing the treatment protocol.
CRO Selection and Financing
Panavance is in the process of selecting a Contract Research Organization (CRO) with relevant disease and clinical trial experience, specifically in ovarian cancer. The company has evaluated seven potential CROs, prioritizing those with expertise in gynecological cancers. Securing financing is a critical next step for initiating the trial. "We have been very open and really direct with our CRO prospects to let them know that our goal is to be ready to engage, but we cannot sign a contract until we have secured funding," Bosch stated.
Challenges and Future Milestones
Panavance initially pursued pancreatic cancer as an indication due to compelling preclinical data and the urgent need for more effective therapies for this difficult-to-treat cancer. However, recruiting patients and progressing them through the trial has been challenging due to the high mortality rate associated with pancreatic cancer. The company hopes to initiate the ovarian cancer trial in the first part of the new year, pending IND approval and securing the necessary financing.
About Misetionamide
Misetionamide (GP-2250) is a novel oxathiazine derivative. Preclinical data suggests a mechanism involving reduction in tumor size. The foundational publication of Misetionamide (GP-2250) in Ovarian Cancer in the journal, “Cancer Medicine” demonstrated a profound antitumor effect when used as monotherapy as well as synergistically when used either in combination with PARP inhibitors or bevacizumab (bev) in preclinical models.
