Advaxis Aims for Orphan Drug Status in Cervical and Head and Neck Cancers
By:
Tomas Ronolski - AllPennyStocks.com News
Tuesday, June 11, 2013
The U.S. Food and Drug Administration has several special designations for expediting development or protecting drugs that meet areas of great unmet medical need. The Orphan Drug Act provides for a special designation for therapeutic candidates treating rare diseases or conditions typically affecting fewer than 200,000 people in the United States. Designation of Orphan Drug status provides a company with several benefits, such as clinical protocol assistance from the FDA, seven-year marketing exclusivity, tax credits, marketing applications that are free of a prescription drug user fee and more.
Some may initially think that the small populations of patients in the rare disorder category may limit revenue potential, but these therapeutics can command high margins. Biotechnology legend Henri Termeer helped build Genzyme into a pharma giant through biologics (that are not easily copied by generics) targeting rare genetic disorders. Genzyme was eventually bought by Sanofi
(NYSE:SNY) for $20.1 billion in 2011.
Upstart biotech Advaxis, Inc. (OTCBB:ADXS) is certainly not a comparable to a behemoth like Genzyme, but the clinical stage company is beating down the path of Orphan Drug designations with their immunotherapy therapeutics that seems worth an investigation. Advaxis is in the midst of six clinical trials, including three Phase II trials for cervical cancer and Cervical Intraepithelial Neoplasia, or CIN. All tallied, the company has 15 immunotherapies in development for cancers and infectious diseases.
On Tuesday, Advaxis reported that it submitted an application for Orphan Drug designation with the FDA for its lead drug candidate, ADXS-HPV, for the treatment of human papillomavirus (HPV)-associated head and neck cancer. About 50,000 new cases of head and neck cancer are diagnosed in the States each year, along with 15,000 deaths being attributed to the disease. HPV is estimated to account for between 20 and 25 percent of the diagnoses. According to the Centers for Disease Control, more than 80 percent of the cases are men. Because of the tie to HPV and cervical cancer, many women today receive HPV vaccinations, lending to the idea of HPV being important in head and neck cancer.
“Data from our Phase 2 study in recurrent cervical cancer show that ADXS-HPV is an active treatment in this HPV-associated cancer. We believe that ADXS-HPV immunotherapy will show similar activity in HPV-associated head and neck cancer, given the shared causality of the cancers,” said Dr. Robert Petit, Chief Scientific Officer of Advaxis.
Advaxis is currently conducting Phase I/II research on HPV-positive head and neck cancer patients in the United Kingdom with plans to bring the clinical research into the U.S. this year. “We believe ADXS-HPV could become an important new non-cytotoxic treatment for patients with HPV-associated head and neck cancer,” added Dr. Petit.
Four days ago, Advaxis disclosed that it filed for an Orphan Drug designation with the FDA for ADXS-HPV for the treatment of invasive cervical cancer. The company is in an ongoing Phase II study in patients with recurrent cervical cancer. More than 12,000 women in the U.S. are estimated by the CDC to be freshly diagnosed with the disease in 2013.
Shares of ADXS have traded as high as 15.5 cents in 2013, but have fallen back to recent lows of 3.7 cents at the end of May. Shares have tumbled again following the company issuing press encouraging shareholders to support a reverse split on Monday. Now…the caveat, as with most OTC-listed companies, is the interpretation of a reverse split. There have been far too many “cries of wolf” over the years by OTC companies claiming that the intentions of a reverse split are to uplist to a senior exchange and generate the attention of institutional investors, create liquidity, etc., which has jaded the interpretation of the phrase. With more than 530 million outstanding shares, Advaxis could certainly use a consolidation of shares. But with a $25 million market cap, the company also seems undervalued given all of the clinical research of the company in the burgeoning field of immunology. The company seems to epitomize the idea of “risk versus reward” at this point. Proper due diligence is, as always, encouraged.
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