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Wednesday, February 05, 2014 8:50:24 AM
Advaxis, a biotechnology company developing the next generation of cancer immunotherapies, says that it has expanded its relationship with the GRU Cancer Center at Georgia Regents University to conduct four Phase 1/2 clinical trials. The strengthened relationship between the company and institution comes after Advaxis’ recent finalization and signing of a master clinical trial agreement with the GRU Cancer Center. Dr. Samir Khleif, Director, GRU Cancer Center and former Chief of the Vaccines Section at the National Cancer Institute, will be serving as the clinical trials’ supervisor as the trials take place.
These trials will serve as means of further development for Advaxis’ two lead immunotherapies: ADXS-HPV for cervical cancer and ADXS-cHER2 for breast cancer. Particularly, the four trials will be designed and enacted for assessing:
– High dose, repeating cycles of ADXS-HPV in recurrent or refractory cervical cancer.
– ADXS-cHER2 in women with Her2/neu over-expressing breast cancer with measurable disease who have progressed after prior standard therapy.
– The optimal combination dose of ADXS-HPV and PD-1 antibody in patients with recurrent or refractory cervical cancer.
– ADXS-HPV prior to surgery in patients with surgically treatable cervical cancer.
Dr. Samir N. Khleif, principal investigator, commented, “The preclinical success we have had with the Advaxis platform technology has prompted us to move into human trials with multiple treatment approaches for cervical and breast cancer. We hope to see positive results in cervical and breast cancer patients as we partner with Advaxis in developing its novel treatments.”
“We are excited that Dr. Khleif, a visionary in oncology, and his elite team at the most prominent center for cancer immunology research will conduct these additional trials with two of our immunotherapies,” commented Daniel J. O’Connor, Chief Executive Officer of Advaxis. “Through our prior collaboration, Dr. Khleif has already generated positive preclinical data using ADXS-HPV in combination with anti-PD-1 therapy.”
For more information, visit: www.advaxis.com
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