Advaxis Announces First Patient Dosed in Global Phase 3 AIM2CERV Trial for High-risk, Locally Advanced Cervical Cancer
PRINCETON, N.J., Feb. 06, 2017 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced that the first patient has been enrolled and dosed in its AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence) trial, the only company-sponsored global phase 3 trial enrolling patients with advanced stage cervical cancer.
AIM2CERV is a global, randomized, 450-patient study evaluating axalimogene filolisbac as an adjuvant therapy following primary treatment with chemotherapy and radiation in patients with high-risk locally advanced carcinoma of the cervix (HRLACC). The primary objective of the trial is to compare disease-free survival (DFS) in patients receiving axalimogene filolisbac to DFS in patients receiving placebo, with secondary objectives including overall survival, safety and tolerability. AIM2CERV is being conducted in collaboration with the GOG Foundation, Inc. under a Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA).
“While some women with cervical cancer are considered cancer-free after chemotherapy and radiation, a significant number will experience a recurrence of the disease that is often more aggressive and results in a poor prognosis. The global reach of the AIM2CERV study is intended to determine whether treatment with axalimogene filolisbac after chemotherapy and radiation can help prevent or delay such recurrences,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “Following recently published data that revealed cervical cancer mortality rates may be exponentially higher in African American women and significantly underestimated for all women, coupled with research last year showing fewer than half of patients with locally advanced cervical cancer receive standard-of-care therapy, the need for new treatment options is more clear now than ever.”
Cervical cancer occurs most often in women who have been infected by the human papillomavirus (HPV) and is the most common HPV-associated cancer in women. According to the American Cancer Society, approximately 12,000 women in the United States will be diagnosed with cervical cancer in 2017. Approximately 4,900 of these patients will be diagnosed with HRLACC, according to the Surveillance, Epidemiology and End Results (SEER) Program. While there are multiple vaccines available to prevent HPV, only one-third of the U.S. population has been vaccinated against the virus and the vaccination rate is lower worldwide. Cervical cancer largely affects women who have not received vaccines or regular screenings.
“Through our National Cervical Cancer Coalition (NCCC), every day we talk to women struggling with cervical cancer and the families of those who have lost loved ones to cervical cancer,” said Deborah Arrindell, Vice President, Health Policy at the American Sexual Health Association, an umbrella organization which includes NCCC. “Just as we need options to prevent HPV-related cancers, there is a significant need for more therapeutic options to treat those with cancer. No woman should die from cervical cancer.”
Axalimogene filolisbac, which received orphan drug designation and Fast Track designation for adjuvant therapy in HRLACC and orphan drug designation for stage II-IV cervical cancer from the FDA and was classified as an advanced therapy medicinal product (ATMP) for the treatment of cervical cancer by the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT), has shown encouraging activity and a manageable safety profile in phase 2 studies. Last year, the company presented positive data from the completed Phase 2 GOG-0265 study showing a promising rate of survival in persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC). Top-line data released in 2016 showed a 12-month overall survival rate of 38 percent observed in 50 patients in the trial. This was a 52 percent improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors. The most commonly reported side effects were hypotension and symptoms related to cytokine release, including nausea, chills and fever. The full data set from the GOG-0265 study will be presented at the Society of Gynecologic Oncology’s 48th Annual Meeting on Women’s Cancer in March.
The company plans to enroll approximately 450 patients at 150 global sites. For additional information, please visit www.clinicaltrials.gov (NCT 02853604) or call 844-783-1529.
About Cervical Cancer
Cervical cancer is the fourth most common cancer in women worldwide and the second leading cause of cancer death in women under age 50. An estimated 500,000 new cases are diagnosed in globally and approximately 270,000 people die of the disease each year. Persistent HPV infection is the most important factor in the development of cervical cancer, research shows. According to the ICO Information Centre on HPV and Cervical Cancer, about 70 percent of cervical cancers are attributed to high-risk HPV strains. The prognosis for women with advanced and recurrent cervical cancer remains poor, with survival of only 4 to 7 months following failure of first-line treatment, research has shown. According to the American Cancer Society, the 5-year survival rate for metastatic disease is at just 15 percent, with the area continuing to be a high unmet medical need.
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 cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, targets HPV-associated cancers and is in clinical trials for three potential indications: Phase 3 in invasive cervical cancer, Phase 2 in head and neck cancer, and Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, a preclinical investigational cancer immunotherapy treatment designed to activate a patient's immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient's tumor, with plans to enter the clinic in 2017.
Advaxis Forward-Looking Statement
This press release contains forward-looking statements, including, but not limited to, statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies, and the safety and efficacy of Advaxis’ proprietary immunotherapy, axalimogene filolisbac. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in Advaxis’ SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2016, which is available at http://www.sec.gov.
Any forward-looking statements set forth in this presentation speak only as of the date of this presentation. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof other than as required by law.
You are cautioned not to place undue reliance on any forward-looking statements.
Released February 6, 2017