SOURCE: Moleculin Biotech, Inc.

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August 03, 2017 07:30 ET

Moleculin Begins Clinical Testing Site Development Efforts in Poland; Selects Bioscience SA as Polish CRO

HOUSTON, TX--(Marketwired - August 03, 2017) - 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.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company's IND for Annamycin being permitted and the Company beginning its planned clinical trials for Annamycin. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contact Information

  • Contacts
    PCG Advisory Group
    Investors:
    Kirin M. Smith
    Chief Operating Officer
    D: 646.863.6519
    E: ksmith@pcgadvisory.com