HOUSTON, TX -- (Marketwired) -- 08/03/17 -- Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical 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 MD Anderson Cancer Center, today announced it has selected Bioscience SA ("Bioscience"), a Polish contract research organization ("CRO") to begin identifying and preparing clinical testing sites in Poland for Annamycin, its drug candidate for the treatment of relapsed or refractory acute myeloid leukemia (AML).
The Company announced on June 15th an expansion of its agreement with Theradex Systems, Inc. to include oversite of clinical trial activity in Poland and the appointment of a Lead European Principal Investigator on July 6, 2017.
"Engaging Bioscience gives us experienced boots on the ground in Poland," commented Walter Klemp, CEO of Moleculin, "which we believe is critical, not only for ensuring tight coordination between the US and Polish sites in our upcoming Annamycin clinical trial (which would commence only if our IND for Annamycin is permitted), but also to ensure we have the full benefit of local knowledge regarding site performance and regulatory compliance."
Mr. Klemp continued: "one of the biggest challenges for most clinical trials is recruiting the right patients on a timely basis. We believe adding Polish sites to our planned trial introduces a significant population of qualified patients, and selecting Bioscience helps ensure we reach those patients effectively and efficiently."
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at MD Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical 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 the Company, please visit http://www.moleculin.com.
About Bioscience SA
Bioscience S.A. is a contract research organization established in 2006 whose operations include the whole of Poland. In 2014, Bioscience expanded its operations to include the Czech Republic and Spain. As a CRO, Bioscience deals mostly in conducting phases I-IV of clinical research on new drugs and medical devices, as commissioned by pharmaceutical, biotechnological and research-oriented companies, and academic clients. Bioscience SA cooperates with Investigators and Sites throughout Poland, and its fields of expertise include research in a range of therapies, including vaccination, cardiology, pulmonology, neurology, nephrology and oncology. To date, Bioscience has managed over 100 clinical trials, treating 12,000 patients and has successfully navigated 52 audits and inspections, including inspections by the FDA and the Office for Registration of Medicinal Products. For more information, please visit http://www.bioscience.pl.
The Company announced on June 15th an expansion of its agreement with Theradex Systems, Inc. to include oversite of clinical trial activity in Poland and the appointment of a Lead European Principal Investigator on July 6, 2017.
"Engaging Bioscience gives us experienced boots on the ground in Poland," commented Walter Klemp, CEO of Moleculin, "which we believe is critical, not only for ensuring tight coordination between the US and Polish sites in our upcoming Annamycin clinical trial (which would commence only if our IND for Annamycin is permitted), but also to ensure we have the full benefit of local knowledge regarding site performance and regulatory compliance."
Mr. Klemp continued: "one of the biggest challenges for most clinical trials is recruiting the right patients on a timely basis. We believe adding Polish sites to our planned trial introduces a significant population of qualified patients, and selecting Bioscience helps ensure we reach those patients effectively and efficiently."
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at MD Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical 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 the Company, please visit http://www.moleculin.com.
About Bioscience SA
Bioscience S.A. is a contract research organization established in 2006 whose operations include the whole of Poland. In 2014, Bioscience expanded its operations to include the Czech Republic and Spain. As a CRO, Bioscience deals mostly in conducting phases I-IV of clinical research on new drugs and medical devices, as commissioned by pharmaceutical, biotechnological and research-oriented companies, and academic clients. Bioscience SA cooperates with Investigators and Sites throughout Poland, and its fields of expertise include research in a range of therapies, including vaccination, cardiology, pulmonology, neurology, nephrology and oncology. To date, Bioscience has managed over 100 clinical trials, treating 12,000 patients and has successfully navigated 52 audits and inspections, including inspections by the FDA and the Office for Registration of Medicinal Products. For more information, please visit http://www.bioscience.pl.
