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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