Here's what the 10Q has to say: Presently the P

Quote:

---

Presently the Phase 1 trial is active but not recruiting patients. We may continue the Phase 1 study while also requesting FDA permission to advance to a Phase 2 study. The purpose of continuing the Phase 1 is to further study Kevetrin's mode of action and its potential benefits to patients. The Phase 1 data were used to design the dosing regimen for the planned clinical study of patients with advanced ovarian carcinoma, subject to FDA guidance and authorization. To date, pharmacokinetic profiles found that the plasma half-life of Kevetrin is relatively short, supporting the projected administration of multiple infusions each week in the next study. The half-lives after the first dose and after the sixth dose do not differ appreciably. Longer durations of Kevetrin infusion have shown prolonged exposure to the drug. Prolonged exposure and high area-under-the-curve (AUC) may be desirable in therapy of solid tumors especially with Kevetrin since activation of cell death signaling requires multiple gene synthesis and the phase or phases of the tumor cell cycle most susceptible to the effect(s) of Kevetrin is not known.

We met with the FDA division responsible for ovarian cancer trials to discuss our clinical path forward. We were given guidance by the Agency in the design of trials for a quicker regulatory path towards (our goal of) regulatory approval. Based on this guidance, we intend to use a combination treatment exclusively in this study. The plan is for Kevetrin to be dosed in combination with liposomal doxorubicin (a drug already approved for treating ovarian cancer) due to Kevetrin's safety profile, potential ability to sensitize the tumor, as well as its abilities to cause apoptosis in cancer cells. In vitro and in vivo animal studies evaluating combinations of Kevetrin and various chemotherapies used in treatment of ovarian cancer have been completed and are supportive of the approach planned. The clinical trial protocol is planned for submission to FDA in May 2016.

---