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Blog Exposure - FDA Lifts Clinical Hold on Advaxis' Cancer Drug

Stock Monitor: Global Cord Blood Post Earnings Reporting

LONDON, UK / ACCESSWIRE / July 17, 2018 / If you want access to our free research report on Advaxis, Inc. (NASDAQ: ADXS), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ADXS as the Company's latest news hit the wire. On July 11, 2018, the Company announced that the US Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for its Phase-1/2 study of axalimogene filolisbac (AXAL). The drug is used in combination with durvalumab for the treatment of patients with advanced, recurrent, or refractory cervical cancer and HPV-associated head and neck cancer. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Advaxis most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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The clinical hold was issued on March 09, 2018, after a patient's death that occurred on February 27, 2018, post-dosing, involving acute respiratory failure after nine months of combination therapy.

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by changing a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens, while neutralizing the tumor's natural protections that guard the tumor microenvironment from immunologic attack.

Trial Results

In a Phase-2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic carcinoma of the cervix (PRmCC), the drug candidate showed a 12-month overall survival rate of 38% in 50 patients. This was a 52% improvement over the 12-month overall survival rate that was expected in the trial's patient population based on prognostic factors.

Axalimogene filolisbac has received a Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase-3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received an Orphan Drug designation in three clinical indications.

Advaxis stated that new guidelines for the early detection and treatment of such rare events have been agreed with the FDA and will be implemented for this combination study. The enrolment and dosing in all other Advaxis and durvalumab clinical programs were not affected by the clinical hold.

Upon the lifting of the clinical hold by the FDA, Kenneth A. Berlin, President and Chief Executive Officer (CEO) of Advaxis, said:

"We are pleased to have resolved this issue with the FDA and will implement these guidelines across Advaxis' portfolio as needed, to ensure patient safety. We remain confident in the safety of axalimogene filolisbac based on our experience in treating approximately 400 patients and more than 1,200 doses across multiple trials in HPV-associated cancers."

About Advaxis, Inc.

Advaxis is a late-stage biotechnology organization which is focused on the discovery, development, and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable the T cells to eliminate tumors.

Stock Performance Snapshot

July 16, 2018 - At Monday's closing bell, Advaxis' stock rose 7.46%, ending the trading session at $1.44.

Volume traded for the day: 2.08 million shares, which was above the 3-month average volume of 736.65 thousand shares.

After yesterday's close, Advaxis' market cap was at $75.23 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.

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