Active Biotech's Anyara well tolerated by cancer patients during phase 1 study

By Angela McDaniels

Seattle, Dec. 15 - Active Biotech AB said 30 patients with non-small cell lung, renal cell or pancreatic cancer have completed treatment with Anyara in the company's ongoing phase 1 dose-escalation study.

Anyara has been well tolerated by the patients, and the maximum tolerated dose has been established at 22 micrograms per kilogram of bodyweight, the company said.

To date, the results achieved fulfill the design criteria for Anyara: the dose is in the order of 200 times higher than that given with the first generation of Anyara, the dose appears to be active in all patients as determined by immunological biomarkers and Anyara is more convenient to administer to patients via injections instead of infusions.

The dose-limiting side effects were fever or hypotension, lasting for a few hours only and easily managed with standard medical interventions, the company said.

Anyara was also found to generate a sustained level of the immunostimulatory cytokine Interleukin 2 (IL-2) after the second day of treatment. Such sustained levels of IL-2 correlated with prolonged survival in patients treated with the first generation of Anyara, the company said.

Also, a selective expansion of Anyara reactive T lymphocytes after treatment serve as a second biological marker, one the company said underscores Anyara's selective immunostimulatory properties in patients with malignant disease.

"Active Biotech's current candidate drug, Anyara has a toxicity profile that is more favorable than predicted. It can be given at significantly higher doses than its predecessor with a manageable and limited spectrum of side-effects," president and chief executive officer Sven Andréasson said in a company news release.

"To explore more fully its efficacy, the ongoing phase 1 study will be expanded to a total of 50 patients. Knowing the maximum tolerated dose of Anyara as a single agent will also accelerate parallel development of Anyara in combination with various chemotherapy regimens."

The trial is ongoing at the Fox Chase Cancer Center in Philadelphia, the Norwegian Radium Hospital in Oslo and at Christie Hospital in Manchester, England. A parallel trial, investigating the drug in combination with Taxotere, is running concurrently at clinics in the United State, Denmark and Russia.

Patients treated with the first generation of Anyara had a high frequency of stable disease and prolonged survival times, the company said. In the ongoing trial, efficacy data will be reported after patients have had adequate follow-up.

Active Biotech is a biotechnology company based in Lund, Sweden, that develops pharmaceuticals for autoimmune/inflammatory diseases and cancer.

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