Theradex tapped as CRO for Ph I/II AML trial
Moleculin Biotech, Inc., a preclinical stage pharmaceutical company, focuses on developing anti-cancer drug candidates. Its lead product candidate is Annamycin, an anthracycline for the treatment of relapsed or refractory acute myeloid leukemia (AML).
According to the company, the candidate has been tested in 114 patients in six clinical trials with little to no cardiotoxicity.
Walter Klemp, Chairman and CEO of Moleculin told us the company chose Theradex after “an extensive evaluation” of half a dozen firms.
“Our choice was driven by a number of factors, including Theradex’s focus on oncology (and especially their experience in AML), their capability in managing trials with sites both in the US and Europe, as well as the relative size of our project in relation to their size,” he said.
Klemp also said the company felt it was valuable to work with a firm for which its project was meaningful and important, “not a rounding error to their operation,” but also “not so large as to tax their infrastructure.”
As such, “there seemed to be a perfect fit here on all fronts,” he added.
The CRO will be providing a range of project management services covering most aspects of the upcoming AML trial.
“As soon as our IND is approved, we will be engaging with IRB’s to seek site-level approval for our clinical protocol and will be working with Theradex to conduct site initiation visits to begin the trial,” Klemp explained.
