Moleculin Announces Intent to Expand Annamycin Planned Clinical Trial to Include Sites in Poland
HOUSTON, TX–(Marketwired – June 15, 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 M.D. Anderson Cancer Center, today announced it has asked its contract research organization (CRO), Theradex Systems, Inc., to expand its engagement to include clinical sites in Poland for Moleculin’s planned Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML).
“We have been working on ways to increase our rate of patient accrual once we start our planned clinical trial for Annamycin,” commented Walter Klemp, Chairman and CEO of Moleculin, “and we have identified several promising sites in Poland. By expanding our engagement with Theradex, we help ensure tight coordination of clinical activity between the US and Poland.”
Mr. Klemp continued: “If our IND is permitted, which must happen for clinical trials to begin, we intend to hit the ground running, and we believe Poland improves that capability. AML patients in Poland have less access to clinical trials than those in the US, which should make it easier for us to recruit relapsed or refractory AML patients who have received a fewer number of prior failed treatments and, as a result, may be less resistant to future treatments, and/or whose general health is less severely compromised. Work is already under way to identify a lead European Principal Investigator and to recruit the most appropriate clinical sites for the expansion.”
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical 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 being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule development 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, and the other of which targets the metabolism of tumors.
For more information about Moleculin, please visit http://www.moleculin.com
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, FDA permitting the Company sponsored IND for Annamycin to go into effect, the ability of the Company to receive the requisite local regulatory approvals to conduct part of its clinical trial in Poland, the Company’s ability to attract an appropriate Principal Investigator in Poland, the ability of the Company to open clinical trial sites in Poland, and the Company’s ability to recruit relapsed or refractory AML patients who are considered ‘treatment naïve’. 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.
PCG Advisory Group
Kirin M. Smith
Chief Operating Officer