advaxis inc (ADXS) Key Developments
Advaxis Announces Initiation of Phase 1/2 Trial of ADXS-HPV in Head and Neck Cancer
Nov 20 13
Advaxis, Inc. announced that the Icahn School of Medicine at Mount Sinai (ISMMS) will initiate a Phase 1/2 study of ADXS-HPV in 25 patients with Human Papilloma Virus (HPV)-positive head and neck cancer, a type of cancer which is increasing at an epidemic rate. This clinical trial will be the first study to evaluate the effects of ADXS-HPV in patients when they are initially diagnosed with HPV-associated head and neck cancer, prior to receiving any chemotherapy or radiation. This study will be an important first step toward understanding ADXS-HPV's potential to treat this type of cancer before chemotherapy and/or radiation and its potential to reduce the need for these treatments. In early November, Advaxis announced that it received Orphan Drug Designation from the US Food and Drug Administration for ADXS-HPV for HPV-associated head and neck cancer. ADXS-HPV is Advaxis' lead immunotherapy product candidate for the treatment of HPV-associated cancers and has achieved proof-of-concept, demonstrating encouraging clinical activity and a manageable safety profile in patients with recurrent cervical cancer in a recently completed Phase 2 study. The incidence of HPV-associated head and neck cancers has been increasing at an epidemic rate, while head and neck cancers from other causes has been decreasing. According to the WHO, approximately 15-20% of the 400,000 new cases of head and neck cancer are HPV-related. In the US, there are about 12,000 new cases of HPV-associated head and neck cancer per year. ADXS-HPV has previously demonstrated clinical benefit as a single agent or in combination with chemotherapy in a Phase 2 clinical trial for HPV-associated recurrent cervical cancer.
Advaxis, Inc. Appoints Gregory T. Mayes as Chief Operating Officer
Oct 28 13
Advaxis, Inc. announced that it has appointed Gregory T. Mayes to the new position of Executive Vice President and Chief Operating Officer. Mr. Mayes joins Advaxis following the recent closing of a financing totaling $26.5 million and an up listing to the NASDAQ Capital Market. Mr. Mayes will report directly to Daniel J. O'Connor, Chief Executive Officer, and will be responsible for leading company's business operations, including business development and licensing, legal affairs, commercial planning, information technology, and human resources. Mr. Mayes is the former Executive Vice President, Human Resources for Dendreon Corporation.
Advaxis Announces First Patient Dosed with ADXS-HPV in Head and Neck Cancer Study
Oct 23 13
Advaxis, Inc. announced that the first patient has been dosed in REALISTIC, a Phase 1 study being funded by Cancer Research UK (CRUK) to investigate the use of ADXS-HPV for the treatment of HPV-positive head and neck cancer. This trial is sponsored by the University of Liverpool and Aintree University Hospitals NHS Foundation Trust, Liverpool, UK and is being conducted at the Royal Liverpool University Hospital, Liverpool, UK, the Royal Marsden Hospital, London, UK, and the University Hospital of Wales, Cardiff, UK. The study will investigate the safety and efficacy of ADXS-HPV in patients presenting with HPV related oropharynx cancer and who have been treated with surgery, radiotherapy, and/or chemotherapy; alone or in combination. A maximum of 27 patients are to be enrolled in this study, and the study is funded by Cancer Research UK.
Advaxis, Inc.(NasdaqCM:ADXS) added to NASDAQ Composite Index
Oct 18 13
Advaxis, Inc. will be added to NASDAQ Composite Index.
Advaxis, Inc. Reports Earnings Results for the Third Quarter and Nine Months Ended July 31, 2013
Sep 20 13
Advaxis, Inc. reported earnings results for the third quarter and nine months ended July 31, 2013. For the quarter, the company reported that net loss applicable to common stock was $1.78 million, or $0.37 loss per share, compared to a net loss applicable to common stock of $3.29 million, or $1.19 loss per share, for the same quarter ended July 31, 2012. Loss from operations was $3.05 million, compared to a loss from operations of $3.58 million for the same quarter ended July 31, 2012.
For the nine months ended July 31, 2013, net loss applicable to common stock was $13.13 million, or $3.13 loss per share, compared to a net loss applicable to common stock of $10.63 million, or $4.45 loss per share, for the same period ended July 31, 2012. Loss from operations was $10.71 million, compared to a loss from operations of $10.06 million for the same period ended July 31, 2012.