ANYARA – unique substances for use in fighting cancer
Active Biotech’s ANYARA project develops a drug primarily for the treatment of renal cell cancer using TTS (Tumor Targeted Superantigens) technology.
Renal cancer
Renal Cell Carcinoma ("RCC") affects approximately 180,000 people worldwide each year. Half of patients are affected by metastases. If the disease has metastasized, average survival is one year. The survival rate of patients diagnosed with renal cancer is only 5-10% after five years (Cowen & Co, Therapeutic Categories Outlook, March 2009).
RCC is traditionally treated with relatively high doses of the cytokines interferon alfa or interleukin-2. The market for treatment of RCC is estimated at approximately USD 1 billion per year (GlobalData 2010). Recently approved treatments are Sutent, Nexavar, Torisel and Avastin.
Ongoing research
A pivotal Phase III study of ANYARA in combination with interferon-alpha, compared with interferon-alpha alone, in patients with advanced renal cancer is ongoing. Over 500 patients are included in the study. The primary endpoint is overall survival.
Current results
Patient enrollment to the Phase III clinical trial was completed 1 June after enrollment of over 500 patients into the study. Final survival data for ANYARA will be analyzed after 384 events and the current estimate is that these will be presented first half of 2011.
In May 2008, an interim analysis was performed in the ongoing Phase II/III clinical study of ANYARA, in patients with advanced renal cell cancer. The study protocol was reviewed in a protocol assistance procedure by EMEA and the primary as well as all secondary endpoints were endorsed.
In the interim analysis safety, efficacy, as well as certain biomarkers were evaluated in approximately 200 patients. No safety concerns significantly affecting the risk/benefit ratio for ANYARA were identified. Based on the study data, Active Biotech decided to proceed, in accordance with the study protocol into the pivotal Phase III stage of the study to further evaluate the effect of ANYARA for treatment of renal cell carcinoma.
Survival data from the ANYARA Phase I study in renal cell cancer patients, which was concluded in 2006, confirms the positive data that was achieved in the previous generation of the project. The median survival for the 11 patients who received treatment was 26.2 months.