Bioniche Reflects On Its Product Performance

After initial dosing problems, Canadian biopharmaceutical company Bioniche has announced that its mycobacterial cell wall extract product Regressin, an immunotherapeutic with multiple potential indications, seems to be back on the developmental track.

Since 1994, the company has expanded its Phase II/III trials of the agent in its first indication, bladder cancer, to 16 centers in Canada, and it has also identified a number of new indications, including prostate cancer (for which Phase I/II trials are now ongoing), malignant melanoma (Phase I/II), osteosarcoma, venereal tumors, breast cancer and the treatment of hepatitis B virus infection. Data generated to date in the bladder cancer program have confirmed the company's initial expectations that Regressin will be a very safe product with a minimal side-effect profile. Bioniche is now in the process of conducting a series of dose-ranging studies to define the best possible regimen to use in a pivotal trials program.

The rationale behind Regressin represents an extension of an existing treatment for superficial bladder cancer, the intravesical administration of Bacille-Calmette-Guerin (BCG) vaccine. This adjuvant treatment has been quite successful but is limited by side effects such as severe injection site reactions, tuberculosis-positive reactions and the risk of bacterial colonization. It has also proved ineffective in other tumors. Regressin was designed in the 1980s to overcome some of these limitations.