Moleculin Biotech has signed an agreement with contract research organisation Catalyst Clinical Research for the trial of Annamycin, a next generation anthracycline.

Under the agreement, Catalyst Clinical Research will manage Moleculin Biotech’s US clinical trial to examine the ability of Annamycin in treating soft tissue sarcoma (STS) that has metastasised to the lungs.

STS is a type of cancer and the most common form of sarcoma. It starts in soft tissues that connect, support and surround other body structures.

Moleculin chairman and CEO Walter Klemp said: “As soon as we received IND (Investigational New Drug) status, we began reaching out to potential clinical sites, and the response has been very positive.

“We believe engaging a well-respected CRO such as Catalyst will enable us to move quickly to initiate sites and get this trial under way.”

Once metastasised to the lungs and if the tumours cannot be removed through surgery, the primary chemotherapy regimen is the anthracycline doxorubicin, dubbed ‘Adriamycin’.

However, only 10% to 30% of patients with sarcoma lung metastases may initially respond to doxorubicin and the most will relapse, leaving the majority number of these patients without any other chemotherapy alternative.

Recently, Annamycin has been shown in animal models ‘to accumulate in the lungs at up to 34 times the level of doxorubicin’.

Catalyst CEO Nick Dyer said: “It’s clear there is a significant unmet need for an improved therapy for STS lung metastases.

“Catalyst Oncology is thrilled to be the selected partner to collaborate with Moleculin on this potentially ground-breaking study.”

Based in the US, Moleculin Biotech is engaged in the development of a wide range of oncology drug candidates used for treating highly resistant tumours and viruses.

In April 2019, Moleculin undertook and enrolled patients in two anti-cancer clinical trials in Poland.