human lungs

The US Food and Drug Administration (FDA) has granted fast-track designation for Peregrine Pharmaceuticals’ lead investigational immunotherapy ‘bavituximab’ to treat patients with second-line non-small cell lung cancer (NSCLC).

Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is currently being evaluated in several solid tumour indications, including non-small cell lung cancer, breast cancer, liver cancer and rectal cancer.

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PS is a highly immunosuppressive molecule that is usually located inside the membrane of healthy cells, but ‘flips’ and becomes exposed on the outside of cells that line tumour blood vessels, creating a specific target for anti-cancer treatments.

Peregrine head of regulatory affairs Robert Garnick said: "We are very pleased that the FDA has recognised the potential of this novel therapy as a treatment for this serious and devastating type of cancer and look forward to working closely with them to ensure the most efficient review process."

FDA’s fast-track programmes are designed to facilitate the development and speed-up the review of new drugs that are aimed at treating serious or life-threatening conditions and that show the potential to address unmet medical needs.

"We are very pleased that the FDA has recognised the potential of this novel therapy as a treatment for this serious and devastating type of cancer."

Peregrine has also recently started a Phase III clinical trial called ‘SUNRISE’ (‘Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study’), which compares bavituximab and the chemotherapy docetaxel against placebo, as well as docetaxel in this indication.

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The global, randomised, double-blind, placebo-controlled SUNRISE trial is designed to assess the safety, tolerability and efficacy of bavituximab plus docetaxel in patients with NSCLC.

Around 600 patients will participate in the SUNRISE trial, which is expected to be conducted at more than 100 clinical sites worldwide.

According to the company, patients with stage IIIb/IV non-squamous, NSCLC, who have progressed after standard front-line treatment are eligible for enrolment in the trial.

Patients will be randomised into one of two treatment arms and all patients will receive up to six 21-day cycles of docetaxel (75mg/m2) plus weekly infusions of either bavituximab (3mg/kg) or placebo until progression or toxicity.

Image: A 3D image of a chest X-ray, lungs sagital plane. Photo: courtesy of Freedigitalphotos.net.