Advaxis was the recipient of the Novartis sponsored Best Therapeutic Vaccine Award at the 5th Annual Vaccine Industry Excellence Awards, which were "created to honor and generate recognition of the efforts, accomplishments, and positive contributions of companies and individuals in the vaccine industry."
Advaxis received the award due to "progress made to date through clinical trials and/or achieved milestones" and "advanced efficacy, safety, and risk management data where appropriate."
In February, Advaxis announced encouraging results from "the first of 3 dose cohorts in the single blind, placebo controlled Phase II dose escalation study assessing the safety and efficacy of ADXS-HPV in the treatment of cervical intraepithelial neoplasia (CIN) 2/3."
Below is a summary of the Cohort 1 results:
- "In the ADXS-HPV arm, 52% of CIN 2/3 lesions regressed from CIN 2/3 to CIN 1 or normal. This means surgery is longer be required. The dose in cohort 1 is about 1/20th of the dose being used in trials of ADXS-HPV in cervical cancer.
- This 52% regression rate of ADXS-HPV with the lowest dose tested is very encouraging. According to the American Academy of Clinical Research’s Task Force on the Treatment and Prevention of Intraepithelial Neoplasia, 50% objective regression rate with a new treatment agent is considered clinically meaningful.
- Further, according to O’Shaughnessy, et al 2002, CCR, 8:314, “An improvement in CIN 2/3 to either pathologically normal cervix or of CIN 3 to CIN 1, with no new CIN 2/3 lesions appearing in at least 50% of the treated patients, is evidence of clinical benefit of the new agent.”
- In the cohort 1 trial, 40% of CIN 2/3 lesions spontaneously regressed in the placebo arm. This is within the range reported in the scientific literature of 35%-43% (Wright, et. al. 2003. Am J Obstet Gynecol, Am. J. Obstet. Gynecol. 289:295).
- ADXS-HPV is safe. Less than 1/3 (29%) of the patients treated reported any side effects associated with treatment. Those that occurred were mild and self-resolved or responded quickly to treatment.
- No SAEs (serious adverse events) were reported." Read more about the trial at Advantage.Numoda.com.
"We are delighted to receive recognition for our Company's achievements in developing ADXS-HPV. Our team continues to bring our proprietary platform technology from the laboratory into the clinic and meet major milestones in development in HPV caused cancers and soon in prostate and breast cancer, as well."
Read more at FierceVaccines.com.