March 10, 2009
ADVAXIS SUBMITS ADXS11-001 FOR ORPHAN DRUG DESIGNATION
North Brunswick, NJ – March 10, 2009 – Advaxis, Incorporated (OTCBB: ADXS), today submitted to the US Food and Drug Administration (FDA) its lead drug candidate, ADXS11-001 (formerly known as Lovaxin-C), for Orphan Drug Designation (ODD) to treat invasive carcinoma of the cervix.
Orphan Drug Designation is intended to support the clinical development of drugs to treat diseases that affect less than 200,000 people in the United States. If approved, such a designation would grant Advaxis fast-track review process as well as market exclusivity for a period of seven years. In addition, Advaxis would be eligible for direct guidance from the FDA for the design of a clinical plan to further develop the drug. By statute, the FDA must review and respond to an Orphan Drug application within sixty (60) days.
The approval time for orphan products is often considerably shorter than the approval time for other drugs. This reduced approval time is due to expedited review or accelerated approval because the drugs treat serious or life-threatening diseases. The Office of Orphan Products Development also administers a clinical research grants program, whereby researchers may compete for funding to conduct clinical trials for rare diseases and conditions.
Advaxis Chairman and CEO Thomas A. Moore commented, “Over 10,000 women a year are newly diagnosed with cervical cancer. Women with the disease who fail cytotoxic therapy have a very short survival prognosis. Our preliminary clinical data indicates our agent may improve the survival of these patients. The ODD program affords us the ability to collaborate with the FDA in a manner that provides a clear and more rapid path to market."
Advaxis Chairman and CEO Thomas A. Moore commented, “As our research team furthers our Lm platform and works on additional strains, some of which are less virulent than others, we are committed to fulfilling the potential that live Listeria-based delivery systems brings to the treatment of cancer."
About Advaxis, Incorporated
Based in North Brunswick, New Jersey, Advaxis is developing proprietary Listeria monocytogenes (Lm) cancer vaccines 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 attenuated live Lm vaccines that deliver engineered tumor antigens, which stimulate multiple simultaneous immunological mechanisms to fight cancer.
I thought about buying ADXS a few weeks ago, but decided against it. I'm always skeptical about vaccines for oncology treatment. The only cancer vaccine that is FDA approved right now is gardisil, and that isn't technically working on cancer, but on the HPV virus. Hopefully, vaccine technology will advance in the future, for oncology patients, but up to now, most vaccines for oncology have been lacking in benefit. So, until ADXS can show good data in phase II or III trials, I'm holding on it.
Doc...you may have to reevaluate the future promise of vaccine uses for cancer.
ADXS is not involved with melanoma research to my knowledge, but it is exciting to think that vaccine technology is becoming more mainstream. I hear ya...only Gardasil currently FDA approved and Gardasil has associated problems, but the vaccine arena is starting to become more and more appealing from a investor's perspective and hopefully vaccine's will one day fulfill patient needs also! My best to you doc.