On April 29, 2019 Moleculin Biotech A small public company reported with 6 highly promising anti-cancer drugs in the pipeline is augmenting US clinical trials with trials in Poland, speeding the process of patient recruitment and data collection (Press release, Moleculin, APR 29, 2019, View Source [SID1234535436]). The company, Moleculin (NASDAQ: MBRX), recently recruited 3 patients in 6 weeks in Poland, whereas in the U.S. it took a full year to build a similar, complete cohort. The company now has 2 clinical trials with patients enrolled in Poland.

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The phase 1/2 clinical trial now underway in Poland for the company’s Annamycin compound has already shown promising results with one trial patient’s acute myeloid leukemia (AML) now in remission, making the patient eligible for a bone marrow transplant. While significant additional study is necessary to definitively demonstrate causality, Moleculin has already begun to identify more patients in Poland for the next cohort of the same trial and 2 more patients for its WP1220 topical treatment of cutaneous T-cell lymphoma (CTCL).

"The clock is ticking for many patients suffering from hard-to-combat cancers," said Walter Klemp, CEO, Moleculin Inc. "For a smaller pharmaceutical company with a promising roster of drug candidates for targeting these highly resistant tumors, speed in launching trials is critical. We feel lucky to have found a well-established medical community where access to patients is easier and faster. If the promising results continue, we look forward to getting our drugs into the hands of such patients much sooner."

"While the response of a single patient doesn’t necessarily predict the outcome of the trial, this is a great way to begin and it’s consistent with our expectations for Annamycin," Mr. Klemp continued. "We have seen no evidence of cardiotoxicity in any of the patients treated thus far and intend to advance the clinical study of Annamycin with the goal of ultimately demonstrating the drug’s safety and effectiveness to support regulatory approval in the US and European Union."

The additional patient safety data gained from the Polish trials may also assist in the FDA’s review of cardiac safety which can be a key factor in regulatory approval.

US Market Recruitment Challenges

Without data from clinical trials, drug development companies have no way forward. However, recruiting for anti-cancer clinical trials in the US can be slow. With large pharma companies targeting the US market with both ground-breaking and "me-too" drugs, there is significant competition for patients in the United States.

Also, oncology clinical trials are typically conducted in one of 61 major cancer centers in urban areas, making it difficult for qualified rural patients to participate. Elderly American patients often decline because they or their families have caregiving and scheduling demands that make such trials difficult.

Other issues that make trials difficult include insurance and financial concerns, as insurers often require that clinical trials be conducted in-network.

To build a larger base of clinical trial patients more quickly, Moleculin began working with the medical community in Poland, where the company’s Founding Scientist Dr. Waldemar Priebe was born. Currently a researcher at M.D. Anderson Cancer Center in Houston, Priebe is extremely familiar with the Polish medical establishment. As a location for clinical trials, Poland has a medical infrastructure and community acceptable to the FDA and offers many benefits to the small biopharma. These include:

Highly rated medical infrastructure and medical community (Poland is ranked seventh in Europe for clinical trial participation, with an annual average of about 40,000 patients in clinical trials. The clinical trial market there was estimated to be about 200M euros as of 2014.
With fewer drug developers, there is less competition for clinical trial patients in Poland.
A greater number of patients who are "treatment-naïve," meaning they are less likely to have resistant cells from other medical treatments.
The European Medicines Agency is receptive to starting clinical trials at higher, more therapeutic drug doses.
For the current Moleculin Polish trial, the allowable starting dose was 120 mg/m2, offering the opportunity to provide patients with what the Company considers a potentially more therapeutic dose than the 100 mg/m2 required in the US. Once 3 patients have completed the safety evaluation period of the first cohort in Poland, the second cohort will begin there at a dose level of 150 mg/m2.