Virulizin®
Immunotherapy is a promising therapeutic method that harnesses the power of the immune system to fight cancer. Virulizin® is a novel immunotherapy agent that stimulates the body’s immune system through several mechanisms, including the activation of macrophages and the infiltration of natural killer cells into tumors. Virulizin® also induces the expression of several cytokine proteins such as IL-12 and IL-17E, which act as chemical messengers to boost the cellular immune response against cancer. These combined activities have significant antitumor effects, while showing a high margin of safety.
In preclinical studies, Virulizin® has demonstrated antitumor activity against a wide range of cancer indications, including breast, ovarian, and pancreatic cancers. Virulizin® has been evaluated in hundreds of cancer patients and has demonstrated an excellent safety profile with only a small number of mild adverse events. Virulizin® has completed three Phase I/II clinical studies in solid tumors and pancreatic cancers. Virulizin® has also completed a randomized placebo-controlled Phase III trial for the first line treatment of pancreatic cancer in combination with gemcitabine. Top-line results from the trial did not demonstrate statistical significance in median overall survival but exploratory analysis showed promising trends in specific patient populations. As in earlier clinical trials, Virulizin® treatment was well tolerated with no major side effects.
Lorus provides technical assistance and know-hows to its partner Zor Pharmaceuticals who is currently planning for additional clinical studies to confirm the survival benefit associated with Virulizin® in a predefined patient subpopulation. These clinical trials will be designed to support approval of Virulizin® in jurisdictions covered under our license agreement with Zor (North, Central, and South America, Europe, and Israel). We also believe that Virulizin® has strong market potential for other countries throughout the world, which will be exploited by Lorus’ partner and holder of the Virulizin intellectual property portfolio, The Erin Mills Investment Corporation (TEMIC), who will be responsible for all developmental costs not covered by the ZOR license agreement.
Virulizin® has been granted orphan drug status and fast track status from the United States FDA and orphan designation from the Marketing Authorization Application with the European Medical Evaluation Agency (EMEA) for treatment of pancreatic cancer. Virulizin® is protected by multiple patents worldwide, as part of Lorus’ extensive intellectual property estate.