BioCis Pharma Starts a Phase I Clinical Trial with a New Cancer Drug

2009-05-28

Turku - Finland - May 28, 2009 - BioCis Pharma Ltd., a privately-held drug development company with its headquarters in Turku, Finland, has started Phase I clinical testing of ProtoCure(TM) intravesical instillation solution, a novel anti-cancer drug for urinary bladder cancer. ProtoCure is based on a new mechanism of action discovered and developed by BioCis Pharma which effectively prevents cancer growth and proliferation locally.

The open-label, dose-escalating study is designed to evaluate the safety, tolerability and pharmacokinetics of the locally administered (into the bladder) product in a total of 22 patients with primary or recurrent non-muscle invasive bladder cancer and it is expected to be well tolerated.

"We are pleased to advance to clinical testing with the ProtoCure instillation solution," says Lasse Leino, CEO of BioCis Pharma. "It is our first oncology product to reach this important milestone and follows the initiation of two phase 2a studies with our leading antiinflammatory product in patients with inflammatory skin disorders that we recently announced. The ProtoCure cancer drug holds great promise for patients suffering from superficial bladder cancer. We are committed to take the product quickly to more extensive clinical efficacy testing after this preliminary safety study. We expect to get results from this study by the first quarter of 2010."

Bladder cancer is the fourth most common cancer in men and tenth among women. In addition, the recurrence rate is high, being almost 70 % in patients with the non-invasive form of the cancer, where the malignancy is typically found in the surface layers of the bladder. Non-invasive bladder cancer is treated by urologists using local surgery and intravesical drug therapy administered directly into the bladder. Existing drug therapies often have undesirable side effects and limited efficacy.