Advaxis Partners with Gynecologic Oncology Group for Phase II Study of Company's Lead Cervical Cancer Vaccine.NORTH BRUNSWICK, N.J. -- Advaxis, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : ADXS) has received confirmation that the Gynecologic Oncology Group The Gynecologic Oncology Group (GOG) is a non-profit organization funded by the National Cancer Institute with the purpose of supporting research for the prevention and treatment of all gynecologic cancers, such as ovarian cancer, cervical cancer, endometrial cancer, vulvar cancer, (GOG), a therapeutic clinical research group of the National Cancer Institute (NCI See Liberate. ) has agreed to conduct and help fund a future Phase II trial of Lovaxin C. This trial is expected to begin following completion of the Company's current Phase I/II trial. To date, Advaxis has completed enrollment and dosing of the first two of four cohorts consisting of patients diagnosed with advanced, recurrent or progressive cervical cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. . Review by an independent safety panel has found that this assessment, the first in humans, of a modified Listeria-based live vaccine live vaccine n. A vaccine prepared from living attenuated organisms or from viruses that have been attenuated but can still replicate the cells of the host organism. is safe. Dosage escalation is ongoing. Dr. John Rothman, Vice President of Clinical Development for Advaxis said, "The GOG is an extremely competent and experienced group of clinical researchers. Their interest in collaborating with Advaxis is very encouraging. The GOG has a thirty-year history of facilitating the development of many therapeutic agents that were once novel and today are well accepted as effective drugs. Our collaboration with this excellent research group will enable us to objectively demonstrate the therapeutic efficacy of our Lovaxin C vaccine for the treatment of women with cervical cancer." The primary endpoint of the Company's current Phase I/II is to establish a maximal safe dose of Lovaxin C. To date side effects Side effects Effects of a proposed project on other parts of the firm. have included transient mild to moderate fever and chills, and transient nausea, all of which usually resolve within hours of dosing. Additionally, upon the completion of the Company's Phase I/II Lovaxin C clinical trial Advaxis expects to continue its program in cervical cancer and diseases related to the human papilloma virus human papilloma virus n. Abbr. HPV A DNA virus of the genus Papillomavirus, certain types of which cause cutaneous and genital warts in humans, including condyloma acuminatum. (HPV HPV human papillomavirus. HPV abbr. human papilloma virus Human papilloma virus (HPV) ), as well as other clinical programs addressing areas such as breast cancer in parallel with the GOG program, when finalized. Based on over a decade of work in the laboratory of Dr. Yvonne Paterson at the University of Pennsylvania (body, education) University of Pennsylvania - The home of ENIAC and Machiavelli. http://upenn.edu/. Address: Philadelphia, PA, USA. , the Company's broadly enabling Listeria Listeria /Lis·te·ria/ (lis-ter´e-ah) a genus of gram-negative bacteria (family Corynebacterium); L. monocyto´genes causes listeriosis. Lis·te·ri·a n. technology platform uses modified Listeria monocytogenes to deliver a tumor-specific antigen fusion protein. Listeria has the ability to generate a robust immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. and produce an unusually strong and effective therapeutic immune response to existing cancers and other diseases affecting many related immune mechanisms simultaneously and in an integrated fashion. Advaxis' Listeria-based technology not only generates an unusually profound cytotoxic immune response capable of killing cancer cells, but the Company's proprietary antigen fusion protein technology minimizes the suppressive sup·pres·sive adj. Tending or serving to suppress. Adj. 1. suppressive - tending to suppress; "the government used suppressive measures to control the protest" effects of regulatory T cells that appear to inhibit many vaccines, and also creates a local tumor environment conducive to the therapeutic effects of the activated tumor killing cells. Unlike current products on the market, which are ineffective in women already infected with HPV, which causes cervical cancer, Lovaxin C is designed to treat women who have already developed cervical cancer as a result of the HPV infection. About GOG The GOG is one of the NCI's funded cooperative cancer research groups and the only group which focuses its research on women with pelvic malignancies, such as cancer of the ovary ovary, ductless gland of the female in which the ova (female reproductive cells) are produced. In vertebrate animals the ovary also secretes the sex hormones estrogen and progesterone, which control the development of the sexual organs and the secondary sexual , uterus, and cervix. The GOG's main objective is to test new ideas for prevention of female pelvic malignancies and management of patients with such malignancies. Currently over 3,300 patients are registered each year to GOG research trials. To date, GOG has completed over 300 clinical trials and contributed over 550 manuscripts to the peer reviewed medical literature. About Advaxis Based in North Brunswick, New Jersey, Advaxis is developing proprietary Listeria cancer vaccines Cancer vaccines A treatment that uses the patient's immune system to attack cancer cells. Mentioned in: Pancreatic Cancer, Exocrine based on technology developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania, and chairperson of Advaxis' Scientific Advisory Board. Advaxis' is developing therapeutic cancer vaccines that enhance the immune system's cancer-fighting abilities through its proprietary Listeria monocytogenes based system, which utilizes two immunological mechanisms (Innate and Classical Immunity) to develop safer and more effective Listeria based cancer vaccines. Advaxis is the exclusive licensee of a patented broadly enabling Listeria platform technology that can elicit effective anti-tumor responses. Advaxis' lead Listeria vaccine candidate, Lovaxin C, targets cervical and head and neck cancers. Further Listeria vaccines in development target breast, ovarian and lung cancers. Advaxis has entered a Phase I/II clinical trial. The Listeria platform will also have applications in the fields of infectious disease and autoimmune disorders. Forward-Looking Statements Certain statements contained in this press release are forward-looking statements that involve risks and uncertainties. The statements contained herein that are not purely historical are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements deal with the Company's current plans, intentions, beliefs and expectations and statements of future economic performance. Forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results in future periods to differ materially from what is currently anticipated. Factors that could cause or contribute to such differences include those discussed from time to time in reports filed by the Company with the Securities and Exchange Commission. The Company cannot guarantee its future results, levels of activity, performance or achievements. |
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