Myelo Therapeutics conducts successful Pre-IND meeting with FDA

Completes new financing round

22-Jun-2017 - Germany

Myelo Therapeutics GmbH announced that it successfully conducted a Pre-IND (Investigational New Drug) meeting with the FDA Center for Drug Evaluation and Research (CDER) on May 11th, 2017 for Myelo001, a novel, orally bioavailable small molecule to prevent myelosuppression caused by chemotherapy. Following the positive meeting with the FDA, the company closed a new financing round with its current investors on June 12th, 2017.

Myelo001 is currently being investigated in a randomized, double-blind, placebo-controlled, parallel-design, multicenter study in Germany regarding its efficacy and safety in reducing Chemotherapy-induced Neutropenia (CIN) in patients receiving adjuvant or neoadjuvant chemotherapy for the treatment of breast cancer. The completion of the study is expected in the fourth quarter of 2017.

A Pre-IND meeting provides an opportunity for communication between a sponsor and the FDA to discuss planned IND application content and to obtain regulatory advice on planned development activities. During the meeting, the FDA clarified the way forward for Myelo001 until New Drug Application (NDA) filing in the US. The comprehensive discussion included the target product profile (TPP) and R&D development plan for Myelo001 in Chemotherapy-induced Neutropenia until reaching US market authorization.

Following the positive meeting with the FDA, Myelo Therapeutics closed a financing round to support further development activities for Myelo001 in Chemotherapy-induced Neutropenia. The funds raised will also expand research into the protective effects of Myelo001 against radiation, which could broaden the potential indication in supportive cancer care to Radiation-induced Myelosuppression.

https://www.bionity.com/en/news/163779/myelo-therapeutics-conducts-successful-pre-ind-meeting-with-fda.html