Moleculin Announces Successful Engineering Run For Production Of Annamycin
HOUSTON, TX - July 19, 2016 - Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today confirmed that it has validated an engineering run of Annamycin from a new combination of suppliers. Davos Pharma of Upper Saddle River, New Jersey successfully coordinated the conversion of Annamycin API (Active Pharmaceutical Ingredient) into L-Annamycin, the final drug product to be used in our next planned clinical trial.
"Production of the liposomal nanoparticle form of Annamycin is a complex process requiring highly specialized facilities," said Walter Klemp, Chairman and Acting CEO of Moleculin. "Our longstanding partnership with Davos Pharma made it possible to coordinate production of Annamycin API by an existing supplier, Olon S.p.A., in Italy and conversion of that API into finished drug product by Symbiosis Pharmaceutical Services, a Scottish contract pharmaceutical manufacturer, who had not previously worked with Annamycin. Importantly, we believe both manufacturers have the experience and capability to supply Annamycin on a commercial scale."
"Being able to successfully validate the drug from this engineering run increases our comfort that we will have adequate supply of Annamycin for our planned Phase IIb clinical trial," Mr. Klemp continued. "It also allows the management team to focus on the goal of obtaining an accelerated approval pathway for Annamycin based on the encouraging results from the last Phase I/II clinical trial for the treatment of acute leukemia."
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.
For more information about Moleculin, please visit http://www.moleculin.com
"Production of the liposomal nanoparticle form of Annamycin is a complex process requiring highly specialized facilities," said Walter Klemp, Chairman and Acting CEO of Moleculin. "Our longstanding partnership with Davos Pharma made it possible to coordinate production of Annamycin API by an existing supplier, Olon S.p.A., in Italy and conversion of that API into finished drug product by Symbiosis Pharmaceutical Services, a Scottish contract pharmaceutical manufacturer, who had not previously worked with Annamycin. Importantly, we believe both manufacturers have the experience and capability to supply Annamycin on a commercial scale."
"Being able to successfully validate the drug from this engineering run increases our comfort that we will have adequate supply of Annamycin for our planned Phase IIb clinical trial," Mr. Klemp continued. "It also allows the management team to focus on the goal of obtaining an accelerated approval pathway for Annamycin based on the encouraging results from the last Phase I/II clinical trial for the treatment of acute leukemia."
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own immune system. The other portfolio targets the metabolism of tumors.
For more information about Moleculin, please visit http://www.moleculin.com