05/15/2019 | Press release | Distributed by Public on 05/15/2019 08:59
Nanocap Advaxis, Inc. (NASDAQ: ADXS) is seeing strength Wednesday following an announcement concerning its cervical cancer drug.
Advaxis announced the lifting of a partial clinical hold the FDA had imposed on the Phase 3 trial of axalimogene filolisbac, which is being tested in patients with high-risk, locally advanced cervical cancer. The FDA acknowledged in its communication to the company that all hold questions have been satisfactorily addressed.
The regulatory agency had imposed the partial clinical hold Jan. 23, as it requested additional information pertaining to certain chemistry, manufacturing and controls matters regarding the pipeline asset, although it did not cite any safety issues.
Following the development, enrollment into the trial was stopped.
Axalimogene filolisbac is Advaxis' lead candidate. There is an unmet need for cervical cancer patients, as the current treatment option guarantees only three months of additional survival. For those patients who fail this option, there is no FDA-approved therapy.
Over 4,000 women die from cervical cancer in the U.S. each year, according to the company.
Advaxis said it will now work with its contract research organization to reopen enrollment for the study.
Advaxis shares were higher by 11.4 percent to $3.61.