Incentive Programs

Yesterday we filed our Form 10-K for the fiscal year ending October 31, 2013. Our financials tell the story of a small biotech that was able to complete a big financing and establish itself as a NASDAQ listed company. The financial stability we gained in 2013 supports our overarching business and clinical goals- mainly focused on advancing our technology to registrational trials in cervical cancer, while also pursuing multiple indications for our immunotherapies. Our plans to advance ADXS-HPV to approval for cervical cancer are definite, and we have pursued incentive programs offered by the U.S. FDA to assist us in moving this program forward.

One program is Orphan Drug Designation (ODD), which offers, among other development incentives, seven years of market exclusivity to approved drug products that treat rare diseases or conditions affecting fewer than 200,000 people. We have already received ODD for HPV-associated anal cancer and head and neck cancer. We recently had a discussion with the FDA about why our ODD request for cervical cancer was denied and, based on those discussions, we intend to submit a new application in the upcoming weeks. Even with ODD, the safety and effectiveness of ADXS-HPV must be established through Phase 3 studies in order to obtain marketing approval and we are committed to conducting these studies with or without ODD from the FDA.

Another program we pursued is Breakthrough Therapy Designation (BTD). BTD allows the FDA to expedite the development and review of drugs that treat a serious or life-threatening disease and that have preliminary clinical evidence indicating a substantial improvement over existing therapies. Based on the preliminary data generated from our Phase 2 study conducted in India in patients with recurrent cervical cancer, where ADXS-HPV demonstrated a well-tolerated safety profile with apparent improved survival, objective tumor responses, and stable disease, we applied for this designation in late 2013. The FDA recently denied our request but stated that we can resubmit a new request once we have new clinical evidence that supports a BTD.

Our goal is to bring our cancer immunotherapies to patients around the world. We will continue to aggressively pursue every FDA regulatory incentive program available to assist us in achieving this goal.

Warm regards,

Dan O’Connor

 

  • alaniii

    January 30, 2014 - 11:37 am

    Dan:

    I do look forward to your blogs. It keeps us up to date. I only hope that the stock price will
    reflect the progress you have made.

    Can you please let me know if we have heard anything about breakthrough status? Have we been denied or still waiting

    I look forward to hearing from you

  • TripNines

    February 1, 2014 - 3:13 am

    Dan, you state that data from phase 2 study demonstrated “apparent” improved survival, “objective” tumor response and stable disease. You also state that although your application for BTD was recently denied, the FDA will allow you to resubmit a new request once you have new clinical evidence that supports a BTD.

    Do you plan to resubmit?

    What “new” eveidence can you supply that you have not already? Not data from a Phase 3, I hope since I don’t see how that could expedite anything.

    Unless your people did a poor job in submitting data for a BTD, the only thing that I can see that would help your cause would be the continued survival of those who have already exceeded longevity expectations. And that will probably take months.

    Not very exciting news for most shareholders who have been underwater with their positions for years.

  • TripNines

    February 20, 2014 - 12:42 am

    Dan,

    Any reply?

    Trip

Dan joined Advaxis in January 2013 as Senior Vice President, Chief Legal and Business Development Officer, was promoted to Executive Vice President in May 2013, and was appointed President and Chief Executive Officer of Advaxis in August 2013.

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