Advaxis Expects That This Clinical Hold Will Be Resolved Expeditiously and Without Significant Interruption to the HPV Clinical Development Program
Conference Call Today, October 6, at 4:30 p.m. ET
PRINCETON, N.J., Oct. 06, 2015 (GLOBE NEWSWIRE) — Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that last Thursday the company received verbal notice from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for axalimogene filolisbac (formerly ADXS-HPV) has been placed on clinical hold, affecting four clinical trials.
The clinical hold, which pertains only to axalimogene filolisbac, was issued in response to Advaxis’s recent submission of a safety report to the FDA. The report involved a single event of one patient with end-stage cervical cancer who last received axalimogene filolisbac in early 2013 in an investigator-initiated trial. In late July 2015, the patient was hospitalized for end-stage cervical cancer symptoms. During hospitalization, routine blood cultures were positive for Listeria monocytogenes (Lm). Subsequent analysis determined that it was the highly attenuated strain of Lm used in axalimogene filolisbac which was incapable of causing infection and was highly sensitive to antibiotics. The patient received a course of intravenous antibiotics and was discharged. The patient returned to the hospital in mid-August, approximately two weeks later, with respiratory distress caused by her metastatic disease. The patient passed away later that day. The investigator ruled that the cause of death was due to progression of her cervical cancer.
The company has evaluated this case and agrees with the investigator’s conclusion that the cause of death was due to cervical cancer progression. The company believes that axalimogene filolisbac played no role in the patient’s death. In investigating this event, Advaxis learned that the patient underwent multiple surgical procedures during the time she was receiving axalimogene filolisbac, including extensive orthopedic reconstruction and receipt of a bone graft and other medical implants. Due to these circumstances, the company believes these implants could have provided a location for axalimogene filolisbac to exist within the body without causing any infection.
Advaxis is working closely with the FDA to facilitate the review and evaluation of this isolated event. The Agency has requested additional information to support a determination that axalimogene filolisbac did not contribute to the patient’s death. This additional information has now been provided to the FDA. Advaxis expects that this clinical hold will be resolved expeditiously and without significant interruption to our HPV clinical development program.
Ongoing clinical trials with Advaxis’s other product candidates, ADXS-PSA and ADXS-HER2, are not affected by this hold and continue to actively enroll and dose patients.
Conference Call Details
Advaxis’s management team will host a conference call and webcast at 4:30 p.m. ET on Tuesday, October 6, 2015 to discuss further details of the clinical hold.
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About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology™.
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology™, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’s lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products, ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.
This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis’s proprietary immunotherapy, axalimogene filolisbac; and the impact of the FDA clinical hold on our axalimogene filolisbac clinical development program. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.
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