01.05.2014 14:06:49

Advaxis Announces Orphan Drug Status For ADXS-HPV In Cervical Cancer

(RTTNews) - Advaxis, Inc., (ADXS), a developer of cancer immunotherapies, said it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration Office of Orphan Products Development for ADXS-HPV, its lead immunotherapy drug candidate, for the treatment of Stage II-IV invasive cervical cancer.

Orphan Drug Designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the U.S.

Orphan Drug Designation entitles the sponsor to clinical protocol assistance with the FDA, as well as annual grant funding, tax credits, waiver of PDUFA filing fees, and potentially a seven year market exclusivity period.

ADXS, which closed up 9.3 percent at $2.72 on Wednesday, climbed 9.9 percent in pre-market trading.

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