Advaxis to conduct cervical cancer trial in India

Advaxis receives formal permission from the Drugs Controller General India (DCGI) to conduct a phase two clinical trial of ADXS11-001, the company's flagship drug construct, among 110 women with advanced, metastatic cervical cancer that has progressed subsequent to treatment with cytotoxic therapy.

55 women will receive ADXS11-001 alone, 55 will receive a combined regimen of both ADXS11-001 and cytotoxic therapy.

The clinical trial will provide a real-time survival assessment; making it possible to evaluate the effect of ADXS11-001 on survival compared to historical norms during the trial. Historically, even when given the most effective regimen tested to date, these patients had a median survival of approximately six months with only five percent surviving one year.

"This design greatly advances the clinical development of ADXS11-001 in a number of ways," said Dr. John Rothman, EVP of science and operations. "If we can duplicate the results of our phase one or improve upon them with three doses of our agent, and if we find our agent to improve the outcome in combination with chemotherapy, then we might be able to show ADXS11-001 to be a safe and effective therapeutic agent where no alternatives exist."

This clinical trial differs from phase one trial in three significant ways: first, unlike phase one in which two doses of ADXS11-001 was administered, this phase two will administer three doses. Second, this randomised trial compares ADXS11-001 alone, to ADXS11-001 given in a combined regimen with platinum based chemotherapy.

Independent research suggests that combined immuno- and chemo-therapy regimens may be more effective than single agent regimens.

Third, the ADXS11-001 regimen has been reduced from a 30 minute 250 ml infusion followed by IV and oral antibiotics over an 11-day period to an 80 ml 15 minute infusion followed by a seven day oral course of antibiotic, which is easier to administer.

Patients will be randomly assigned to receive either three administrations of ADXS11-001 or a single dose of the immunotherapy, followed by cisplatin treatment and then followed by a three course regimen of ADXS11-001. Various clinical and immunologic measures will be taken and survival will be followed for the life of the patient.

ADXS11-001 is a live attenuated Listeria vaccine that targets the human papilloma virus (HPV) oncoprotein E7. HPV is recognised as the cause of cervix cancer and E7 is one of the HPV proteins believed to be responsible. Doses of 1 x 10 (power of 9), 3.3 x 10 (power of 9) or 1 x 10 (power of 10) cfu were administered to groups of five women who had failed prior therapy including radiation and chemotherapy.

In such cases, no therapy has been found to be effective and the median survival, once disease progression resumes, is typically six months or less, depending upon the treatment given. One year survival for these patients historically is approximately five percent.

The phase one trial of ADXS11-001 was intended to assess safety, and like all phase one trials, not powered for efficacy; and so, no conclusions can be made based upon the small number of patients treated. However, in this trial, the median survival was 347 days and the one year survival was 53 percent.