Scanning electron micrograph of a human T cell from the immune system of a healthy donor. Credit: NIAID.

miRagen Therapeutics has reported positive updated data from a Phase I trial assessing the safety, tolerability and efficacy of cobomarsen for the treatment of cutaneous T-cell lymphoma (CTCL) and T-cell leukemia / lymphoma (ATLL).

The data showed that four of eight CTCL patients who received 300mg of intravenous therapy (IV) infusion achieved objective response with greater than four months of durability (ORR4).

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In the 300mg IV infusion cohort, miRagen used the same dose and route of administration being used in the ongoing SOLAR Phase II trial that intends to study the safety and efficacy of cobomarsen against zolinza (vorinostat) in patients with CTCL.

Cobomarsen also showed a favourable safety and tolerability profile among the ATLL patients enrolled in the Phase I trial.

“The ATLL clinical data shows that cobomarsen provided sustained disease stabilisation in five patients for up to 13 months.”

No serious adverse events and no documented opportunistic infections were reported during the trial.

Two lymphomatous and two acute ATLL patients who showed a partial response following chemotherapy have maintained their responses when treated with cobomarsen monotherapy.

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Half of these patients also remained stable for over a year.

miRagen Therapeutics research and development (R&D) executive vice-president Paul Rubin said: “The ATLL clinical data shows that cobomarsen provided sustained disease stabilisation in five patients for up to 13 months after completing chemotherapy or experimental treatment and an improvement in the levels of normal circulating blood cells.

“In addition, patients did not report any significant side effects attributed to cobomarsen.

“We believe these data are particularly encouraging, as the patients in this study had previously failed on other therapies and the median survival for patients with acute disease typically ranges from four to ten months after diagnosis.”