Moleculin Biotech is a clinical stage pharmaceutical company that targets resistant tumors and viruses. January 2022 brought promising details concerning the first 30 patients enrolled in three of their clinical trials with Annamycin. This drug is used to specifically treat relapsed or refractory AML. The study findings indicated that there were no signs of cardiotoxicity (acute and chronic heart damage) after treatment. 

Evidence also showed that Annamycin may lower the chance of alopecia (hair loss) in patients. Typically, doxorubicin is used in treatment and most patients experience hair loss. Annamycin results showed less than 10% of patients experienced alopecia. This finding improves quality of life for cancer patients.

Annamycin Clinical Trials

Two of the three clinical trials being conducted are in Phase I with Phase 2 being determined. 19 of the 30 patients have been given the maximum dose of anthracyclines (a class of chemotherapy drugs). The use of Annamycin now adds significance to current treatment plans. The primary risk when using anthracyclines is heart damage. Annamycin was designed to produce little cardiotoxicity and has the added benefit of minimal hair loss.

“Although anthracyclines continue to be a cornerstone of chemotherapy for many cancer indications, their use has been limited due to the threat of both acute and chronic cardiotoxicity. The availability of an anthracycline that eliminated this risk would be a major advancement in patient safety.”

“Patients often face difficult choices in an effort to balance the objectives of cancer therapy with quality of life. Having the ability to offer patients a treatment alternative that substantially reduces the risk of alopecia would make Annamycin a valuable new alternative for patients who until now have had limited options.”

AML Europe Phase 1 and 2 Clinical Trial:

This trial is in Poland and currently ongoing. Patients are being dosed with 240 mg/m2. Plans are to increase dosing by 30 mg/m2.

AML US Phase 1 and 2 Clinical Trial:

The Annamycin treatment demonstrated no evidence of cardiotoxicity when given to patients at or below the lifetime maximum anthracycline dose set by the FDA. This trial is complete.

Annamycin

Annamycin is a next generation drug that has shown to “accumulate in the lungs at up to 30-fold the level of doxorubicin…it has also demonstrated a lack of cardiotoxicity” in ongoing trials for relapsed or refractory AML. Annamycin is currently on the Fast Track Status for treatment. 

*Annamycin is also being used in a clinical trial for the treatment of STS (soft tissue sarcoma) lung metastases.

According to Moleculin's website, these are the preliminary results of annamycin use in AML:

• 22 patients treated in both US and EU trials
• 7 patients with CR/PR (at subtherapeutic does levels)
• 15 relapsed patients treated in both US and EU trials
• 14% refractory patients with PR
• 40% relapsed patients with CR/PR
• 67% 240 mg cohort patients with CR/PR
• 100% non-cardiotoxic

(CR = complete response, PR = partial response) 

Annamycin is believed to be better than the currently approved induction therapy drugs used in AML because

• It has demonstrated clinical activity in a patient population for whom there are currently no effective therapies,
• It appears to be capable of avoiding the “multi-drug resistance” mechanisms that often limit the effectiveness of currently approved anthracyclines
• In a number of tumor cell lines, it has been shown to be more potent than doxorubicin (one of the leading approved anthracyclines)
• It has been shown to accumulate in certain targeted organs (“sanctuary sites”), including the lungs, liver, pancreas and spleen, at significantly higher levels than doxorubicin.