Advaxis, a clinical-stage biotech company developing immunotherapies for cancer and infectious diseases, today announced it has completed the enrollment of 40 patients for the second of three dose cohorts in the phase II study to assessment the safety and efficacy of ADXS-HPV for the treatment of intraepithelial neoplasia (CIN) 2/3.
Patients enrolled for cohort 2 were randomized 3:1 to ADXS-HPV (3 doses at 3.3×108 cfu) or placebo, which is six times higher than that administered in cohort 1.
Patients will undergo observation for six months after the last dose, after which they will undergo the standard of care surgery (LEEP) required for the treatment of this disease.
Once all patients have completed LEEP, the company will report study results.
"Advaxis continues to meet major milestones in our clinical development plan," Dr. John Rothman, EVP of Science & Operations at Advaxis stated in the press release. "We look forward to assessing the results of the second cohort of this study and to advancing the development of ADXS-HPV for the treatment of HPV-associated diseases."
The company in February 2012 announced the results from the first cohort of the trial, which consisted of 41 patients randomized 3:1 ADXS-HPV (3 doses at 5×107 cfu) or placebo. Results demonstrated that 29 percent of the patients experienced side effects that were related, or were possibly related, to the treatment; no serious adverse events were experienced; 52 percent of CIN 2/3 lesions regressed from CIN 2/3 to CIN 1 or normal in the ADXS-HPV arm; and 40 percent of CIN 2/3 lesions spontaneously regressed in the placebo arm.
For more information visit advaxis.com
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