Phase 2 trial of ADXS11 likely to begin on January 31 (OTC:ADXS)

ADXS11-001 is a “live, attenuated Listeria monocytogenes (Lm)” vaccine that is being developed by Advaxis Inc, (OTC:ADXS). The company had recently completed the Phase 1 trial of the novel vaccine. On October 1, 2009, the company announced that the results received from the Phase 1 trial had been favorable. Now the company plans to begin the Phase 2 trial. However, conducting the trial alone was not easy for Advaxis. As a result, on December 15, 2009, the company decided to form a collaboration with the Gynecological Oncology Group (GOG). GOG is a group of the National Cancer Institute (NCI) that has been previously involved in several collaborative research projects with many reputable pharmaceutical companies. Advaxis plans to start the Phase 2 trial soon, possibly within January 31, 2010.

ADXS11-001 is a vaccine for women who are suffering from cancer of the cervix. This drug is different from prophylactic vaccines which are also sold for treating cervical cancer. The cervical cancer occurs due to human papilloma virus (HPV) infection, which is the most common sexually transmitted disease in the United States of America. The Phase 2 trial, conducted jointly by Advaxis and Gynecological Oncology Group, would measure the effectiveness and the safety of this novel vaccine for treating women who are suffering from an advanced form of the cervical cancer and have previously tried cytotoxic therapy but in vain.

@@CalendarRight@@ Previously, the phase 1 trial of ADXS11-001 showed the potential of this vaccine. In a study that lasted for a long period several years, thirteen women suffering from cervical cancer participated. All these women were administered the ADXS11-001 vaccine. The main objective of the trial was to find whether ADXS11-001 could be used to combat the life threatening cancer and whether the vaccine could help patients live longer. The study results were encouraging. A total of 3 women out of the 13 lived by more than thirty six months (or 3 years). According to the company, the results showed that ADXS11-001 is a potential “therapeutic cancer vaccine” that could help cervical cancer patients develop immunity from the cancer.

The survival rate of the Phase 1 trial participants was much greater than that of the Gynecologic Oncology Group (GOG). The survival rate of the GOG fluctuates between 3.8 and 6.2 months for patients who have taken cytoxic treatments (like chemotherapy) before but who achieved no benefits from such treatments.

Other results from the Phase 1 trial were also fascinating. For instance, in an article published in the medical journal Vaccine, the company disclosed that four out of the thirteen women faced reductions of their cervical tumors. Two women also reported that the lesions around their cervix vanished. About 53 per cent of the 13 women survived more than a year. Overall, the median survival rate of patients using ADXS11-001 was 347 days. This proved the effectiveness (that is, survival) of this novel vaccine, though the main purpose of Phase 1 trial was to find the level of safety associated with using the vaccine.