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ADVAXIS Has Achieved A Lot In 2011 and Ready To Do Better in 2012 - Analyst Blog

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ADVAXIS Has Achieved A Lot In 2011 and Ready To Do Better in 2012

Grant Zeng, CFA

Advaxis (ADXS) was very busy in the past year and has been quite successful in many aspects which included clinical advancement, business development and financing. We summarize some of the key achievements below to provide investors a detailed picture of how the Company has achieved these and what the Company is ready to do better in the fiscal 2012.

Advaxis Reports Encouraging Preliminary Phase II ADXS-HPV Data

On December 16, 2011, Advaxis, Inc. (ADXS) reported preliminary data on the safety and clinical benefit of ADXS-HPV from an ongoing randomized Phase II trial of ADXS-HPV +/- cisplatin in Indian women with recurrent/refractory cervical cancer at the AACR New Horizons in Cancer Research: Biology to Prevention to Therapy conference on December 14th, 2011 at the Leela Kempinski Gurgaon in Gurgaon, Delhi ( NCR ), India.

As a reminder, Advaxis initiated the above Phase II clinical trial of ADXS11-001 in November 2010 in India for the treatment of advanced cervical cancer patients. About 110 patients will be enrolled in this Phase II trial. Historically, when given the most effective regimen tested to date, these patients have a median survival of approximately 6 months and a 1 year survival of 5%, and so by assessing survival in real time it will be possible to assess the effect of ADXS11-001 on survival versus these historical values before the end of the trial. This randomized trial compares ADXS11-001 alone to ADXS11-001 given in a combined regimen with platinum based chemotherapy at three doses. The primary endpoint is overall survival and secondary endpoints are response rate (RR, RECIST) and progression free survival ( PFS ).

The Phase II data are presented both orally and in a poster presentation.

As of December 5, 2011, 75 patients have received 176 doses of ADVS-HPV. The safety profile of ADXS-HPV is very preferable. No serious adverse events related to ADXS-HPV have occurred. Only 29 (39%) patients experienced Grade 1 or 2, transient, non-cumulative flu-like symptoms that responded to symptomatic treatment or resolved on their own.

Although early in the trial, clinical responses have been seen alone or in combination with chemotherapy and have included 1 complete response and 3 partial responses with >60% reduction in tumor burden among 31 patients scanned. Following table summarize the data of the top 5 patients with tumor burden reduction.

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ADVAXIS INC ( ADXS ): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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