Posted on January 30th, 2014
by Daniel O'Connor
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.
Forward Looking Statements
This blog may contain forward-looking statements, including, but not limited to: statements as to the anticipated timing of clinical studies and other business developments, statements as to the development of new constructs, expectations as to the adequacy of our cash balances to support our operations for specified periods of time and as to the nature and level of cash expenditures, expectations as to market opportunities, our ability to take advantage of those opportunities, and the risk factors set forth from time to time in Advaxis' SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2012, which is available at www.sec.gov. The Company undertakes no obligation to revise these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.