There are many promising biotech companies out there to choose from. One such company, named Vical Incorporated (NASDAQ:VICL), is targeting a cancer known as Melanoma. Melanoma is the most dangerous form of skin cancer, and is the leading cause of death for skin disease. The company has a good pipeline, but its lead candidate is Allovectin.
Allovectin approaching results
Results from a phase 3 trial are approaching for Allovectin. Allovectin is a DNA-based immunotherapy designed to stimulate an immune response in tumors. Allovectin will be used as a first-line treatment for patients suffering from stage 3 and stage 4 Melanoma.
What Vical Incorporated (NASDAQ:VICL) hopes to accomplish as a first-line treatment, is that this vaccine has an improved safety profile over toxic chemotherapy. It is also hopeful that the phase 3 trial will show greater efficacy for patients who suffer from Melanoma against current standard of care treatment.
As mentioned before, Allovectin is in phase 3 efficacy trial, and results are set to be out by mid-2013. At that time we will see more in depth results, and whether the efficacy is greater than that of the current chemotherapy treatments. I feel that Allovectin will prove that vaccines can fight cancer, and that the technology is worth pursuing.
The phase 2 trial had enrolled 127 Chemo intolerant patients. The phase 2 study was done as a single arm study, and it was open label. Vical Incorporated (NASDAQ:VICL) proved the safety of the vaccine,because once the study was completed, there were no severe Grade 3 or Grade 4 adverse events. The overall response rate was great at 11.8%! There were four complete responders in the study, and the other eleven patients were partial responders.
The phase 3 trial is almost complete for Allovectin. Soon, investors and the science community will know whether the vaccine works against late stage melanoma or not. The phase 3 trial began in 2007, and had enrolled a total of 390 patients. Enrollment was completed in 2010, and sometime in 2013, Vical Incorporated (NASDAQ:VICL) will post the results that everyone has been waiting for. The trial had 260 patients take the treatment of Allovectin, while another 130 took standard of care placebo drug alone.
Allovectin, if it proves to be successful, stands to make the company $500 million in sales. The good part about Vical Incorporated (NASDAQ:VICL)’s technology targeting tumors with DNA is that it was also shown to be effective in other tumors. Other indications that can be targeted with Allovectin are: Breast cancer, prostate cancer, head cancer, and neck cancer. With these other indications, Allovectin can become a multi-billion dollar vaccine for the company.
Yervoy in competition mode
There is another biotech company that already has an FDA-approved treatment for melanoma patients. This other biotech company is none other than Bristol Myers Squibb Co. (NYSE:BMY). Their drug, Yervoy, was approved by the FDA on March 25, 2011. On June 6, 2011 Bristol Myers Squibb Co. (NYSE:BMY) reported results of their phase 3 trial of Yervoy. Final results showed that patients taking Yervoy prolonged their lives as opposed to those taking placebo only.
More importantly, Yervoy’s one year survival rate was 46% versus 25% in the control arm. In the second year, the survival rate Yervoy achieved was 24%, compared to only 14% in the control arm. Also, Yervoy saw more survivors in the 3 and 4 year marks than those patients who just took placebo only.
Why Bristol Myers Squibb Co. (NYSE:BMY) should be worried about Vical’s Allovectin is due to its efficacy and safety. If Allovectin comes out with better survival rates and is safer to use than Yervoy, then Bristol-Myers will face stiff competition. That’s the downside to Yervoy, as it has an efficacy situation and safety problems.
The problem with the efficacy is that once the patients receive the doses of Yervoy, it can take weeks for the immune system to start working against the cancer. Thus, the drug doesn’t help all patients in regard to their late stage metastatic melanoma. So, if Allovectin proves efficacy at a quicker stage, it can overtake Yervoy in this regard.
