Advaxis, a clinical-stage biotech company developing the next generation of immunotherapies for cancer and infectious diseases, today issued an updated business outlook for 2013, highlighting its clinical initiatives to advance lead product candidate ADXS-HPV to registrational trials. The company also provided additional development and financial data.
"Earlier in the year, Advaxis stated that it would provide periodic updates to its business outlook and announced two overarching objectives for 2013: one, to advance our lead product candidate, ADXS-HPV, toward a registration development program and, two, to continue to significantly strengthen our financial position," Thomas A. Moore, chairman and CEO of Advaxis, stated in the press release. "We have outlined the progress the Company has made on these two goals, as well as anticipated 2013 milestone events."
Corporate Goals for 2013
» A determination for three applications for Orphan Drug Designations with the FDA for ADXS-HPV in three human papillomavirus (HPV)-associated indications: invasive cervical cancer, anal cancer, and head and neck cancer;
» Initiate dialogue with the FDA to discuss ADXS-HPV clinical development plans for the treatment of cervical cancer;
» Complete the elements required to file an Investigational New Drug (IND) application with the FDA for ADXS-PSA for the treatment of prostate cancer in the first half of 2014;
» Advance the canine osteosarcoma study into Phase 2 and expand to additional collaborative academic centers; and
» File an initial listing application for the NASDAQ Capital Market or NYSE AMEX.
ADXS also provided the following 2013 clinical program update:
» GOG 0265 safety run-in completed and study opened to the GOG group-wide
» Cervical Cancer Program - Final 12-month survival data from the Phase 2 cervical cancer trial announced at the 2013 ASCO Annual Meeting in Chicago in June. Preliminary efficacy data continue to show apparent prolonged survival, durable complete and partial tumor reductions, as well as stable disease with ADXS-HPV alone or in combination with cisplatin. ADXS has made substantial progress in analyzing the Phase 2 data and is planning a study to determine the best dose and dosing regimen to enhance efficacy without compromising the encouraging preliminary safety profile already observed. As of July 2013, 10 patients have been enrolled in the safety run-in portion of the study.
» Head and Neck Cancer Program - Cancer Research UK (CRUK) is funding a Phase 1/2 to evaluate the use of ADXS-HPV for the treatment of 27 patients with HPV positive head and neck cancer. As of July 2013, 16 patients have been enrolled in the study.
» Anal Cancer Program - The Brown University Oncology Group (BrUOG) is funding and coordinating a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer. As of July 2013, 3 patients have been enrolled in the study.
» Canine Osteosarcoma Study - Third dose cohort underway in the canine osteosarcoma study. In this trial, dogs that have undergone SOC for osteosarcoma, and over-express HER-2/neu in their tumors, are treated with ADXS-cHER2. Updated preliminary data show a significant survival advantage for 9 dogs that received SOC plus ADXS-cHER2 compared to 11 dogs, whose owners elected not to participate in the trial, but who were followed for survival. At this point in the study, 8 of 9 dogs treated with ADXS-cHER2 are alive (mean survival undefined), compared with 5 of 11 dogs in the control group (mean survival 265 days).
» Prostate Cancer Program - ADXS plans to file an IND with the FDA for ADXS-PSA in the treatment of prostate cancer in the first half of 2014. In June 2011, the company conducted a pre-IND meeting with the FDA to discuss the CMC, pharmacology, toxicology, and clinical plans for ADXS-PSA. The required toxicology studies have been completed and data analyses are ongoing.
Pertaining to business development, ADXS reports it has established several confidentiality agreements with biopharmaceutical companies for the license of ADXS-HPV in the U.S., Asia, and India. ADXS plans to pursue these negotiations to closure in the coming months.
The company has also entered into a confidentiality agreement with the animal health division of a major pharmaceutical company, among other potential licensing agreements with other companies, for the license of ADXS-cHER2.
ADXS stockholders in June approved the effect of a 1-for-25 reverse stock split and a decrease in authorized shares of the company to 25 million from 1 billion shares. The company intends to seek an uplisting to a national exchange in the near term, and said it believes that the combination of completing the reverse stock split and the contemplated uplisting could heighten the interest of the financial community in Advaxis, potentially increase investor interest in the company, and strengthen its financial health.
For more information visit: advaxis.com
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