Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that last Thursday the company received verbal notice from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for axalimogene filolisbac (formerly ADXS-HPV) has been placed on clinical hold, affecting four clinical trials.
The clinical hold, which pertains only to axalimogene filolisbac, was issued in response to Advaxis’s recent submission of a safety report to the FDA. The report involved a single event of one patient with end-stage cervical cancer who last received axalimogene filolisbac in early 2013 in an investigator-initiated trial. In late July 2015, the patient was hospitalized for end-stage cervical cancer symptoms. During hospitalization, routine blood cultures were positive for Listeria monocytogenes (Lm). Subsequent analysis determined that it was the highly attenuated strain of Lm used in axalimogene filolisbac which was incapable of causing infection and was highly sensitive to antibiotics. The patient received a course of intravenous antibiotics and was discharged. The patient returned to the hospital in mid-August, approximately two weeks later, with respiratory distress caused by her metastatic disease. The patient passed away later that day. The investigator ruled that the cause of death was due to progression of her cervical cancer.
The company has evaluated this case and agrees with the investigator’s conclusion that the cause of death was due to cervical cancer progression. The company believes that axalimogene filolisbac played no role in the patient’s death. In investigating this event, Advaxis learned that the patient underwent multiple surgical procedures during the time she was receiving axalimogene filolisbac, including extensive orthopedic reconstruction and receipt of a bone graft and other medical implants. Due to these circumstances, the company believes these implants could have provided a location for axalimogene filolisbac to exist within the body without causing any infection.
Advaxis is working closely with the FDA to facilitate the review and evaluation of this isolated event. The Agency has requested additional information to support a determination that axalimogene filolisbac did not contribute to the patient’s death. This additional information has now been provided to the FDA. Advaxis expects that this clinical hold will be resolved expeditiously and without significant interruption to our HPV clinical development program.
Ongoing clinical trials with Advaxis’s other product candidates, ADXS-PSA and ADXS-HER2, are not affected by this hold and continue to actively enroll and dose patients. (Original Source)
Shares of Advaxis closed today at $10.31, down $0.92 or 8.19%. ADXS has a 1-year high of $30.13 and a 1-year low of $2.50. The stock’s 50-day moving average is $14.63 and its 200-day moving average is $18.09.
On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on September 18, H.C. Wainwright analyst Swayampakula Ramakanth reiterated a Buy rating on ADXS, with a price target of $30, which represents a potential upside of 166.9% from where the stock is currently trading. Separately, on August 7, FBR’s Vernon Bernardino initiated coverage with a Buy rating on the stock and has a price target of $34.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Swayampakula Ramakanth and Vernon Bernardino have a total average return of -17.4% and -19.2% respectively. Ramakanth has a success rate of 19.6% and is ranked #3720 out of 3770 analysts, while Bernardino has a success rate of 24.4% and is ranked #3745.
Advaxis Inc is a clinical development stage biotechnology company. The company is engaged in developing safe & effective immunotherapies for cancer & infectious diseases.