On September 9, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan for Annamycin, including the clinical study design and dosing strategy for the initial phase 1b/2 protocol for soft tissue sarcomas with lung metastases (Press release, Moleculin, SEP 9, 2020, View Source [SID1234564802]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Moleculin submitted a proposed clinical protocol for FDA review entitled, "Phase 1b/2 Study of Liposomal Annamycin (Annamycin) in Subjects with Previously Treated Soft-Tissue Sarcomas with Pulmonary Metastases." The proposed study is an open-label, multicenter, single-arm, dose escalation and expansion study to evaluate single-agent Annamycin in up to 55 patients with soft tissue sarcoma (STS) with lung metastases for whom chemotherapy is considered appropriate. The primary objectives of the dose escalation phase are to evaluate the safety of Annamycin and identify the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D).

In summary, the FDA, among other items:

did not object to the proposed clinical study design while providing guidance on additional assessments

agreed the proposed dose escalation schedule appeared reasonable

commented regarding the consideration for including adolescents in oncology clinical trials

stated that a repeat dose toxicology study of 3 months is required before initiating a registration study

recommended an EOP1 meeting after completion of the RP2D.

"We are pleased to complete the pre-IND meeting with the FDA, and will move forward with our plans to file the IND by the end of 2020 and initiate a Phase 1b/2 trial of Annamycin for the treatment of soft tissue sarcomas metastasized to the lungs," said Wally Klemp, Chief Executive Officer of Moleculin. "We appreciate the FDA’s guidance as we endeavor to find a cure for certain cancers metastasized to the lungs."