Grant Zeng, CFA
More Encouraging Preliminary Data of Phase II ADXS-HPV Reported at the World Cancer Immunotherapy Conference
On Jan 25, 2012, Advaxis (ADXS) reported updated results from an ongoing randomized Phase II trial of ADXS-HPV +/- cisplatin in Indian women with recurrent/refractory cervical cancer at the World Cancer Immunotherapy Conference in San Diego, California.
This Phase II clinical trial of ADXS-HPV was initiated 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 ADXS-HPV on survival versus these historical values before the end of the trial. This randomized trial compares ADXS-HPV alone to ADXS-HPV 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 (NYSE:PFS - News).
The advanced cervical cancer study is being conducted at 17 sites in India, and as of January 25, 2012, 87 out of a planned 110 patients have been enrolled in the study. To be enrolled in the study, all patients must have been previously treated with radiation, and/or chemotherapy, and the cancer must have resumed growth and in most cases has metastasized, as confirmed by CT or radiologic scan. Because data are available to Advaxis in "real time", the Company is reporting preliminary data on a periodic basis. The initial safety and objective response data for this ongoing study were presented at the AACR New Horizons in Cancer Research: Biology to Prevention to Therapy conference Gurgaon, Delhi (NYSE:NCR - News), India on December 14, 2011.
The objectives of this Phase II trial are to assess the safety and efficacy of ADXS-HPV (1x109 cfu) with and without cisplatin (40 mg/m2) and to determine if ADXS-HPV can be safely administered in combination with platinum chemotherapy. As of January 20, 2012, 87 patients have received 195 doses of ADVS-HPV. No serious adverse events related to ADXS-HPV have occurred. 34% of patients (a total of 30) have experienced an ADXS-HPV drug-related adverse event, consisting of Grade 1 or 2 events that were transient, comprised of non-cumulative flu-like symptoms that responded to symptomatic treatment, or resolved on their own; and 1 Grade 3 event.
As of January 25, 2012, the percentage of patients alive at 6 months is 62% (34/55); at 9 months is 41% (15/37) and at 1 year is 40% (6/15). Clinical responses have been observed in both treatment arms with 3 complete responses (elimination of tumor burden) and 4 partial responses (≥30% reduction in tumor burden) documented to date, which expands on the preliminary data presented at the AACR meeting in December 2011 that reported 1 complete response and 3 partial responses.
Preliminary survival as of Jan 20, 2012
Following table summarize the data of the top 7 patients with tumor burden reduction.
Enrollment in the trial continues and evaluation of safety, clinical response, and overall survival is ongoing.
Our takeaways From the Preliminary Results
• Incidence and severity of adverse effects (AEs) is lower than chemotherapy;
• AEs are acute, Grade 1/2 (no SAEs), transient, non-cumulative, and consist of flu-like symptoms that respond to symptomatic treatment or resolve on their own;
• Clinical benefits have been observed in refractory disease setting;
• Tumor responses (including 3 CR and 4 PR’s) have been observed in both treatment arms;
• Preliminary survival data are very encouraging.
The preliminary data are very encouraging. The safety profile is excellent and great efficacy has been observed. Although it’s too early to assess the primary endpoint: overall survival, the preliminary survival data and the early responses, which are the secondary endpoint, are very promising.
The positive ADXS-HPV data further convince us that shares of Advaxis are undervalued. We continue to rate the Company Outperform and reiterate our price target of $0.50 per share.
New Phase II of ADXS-HPV for Cervical Cancer Initiated by GOG/NCI
On Jan 11, 2012, Advaxis announced at the OneMedForum in San Francisco that patient dosing has begun in the Gynecologic Oncology Group (:GOG) 67 patient Phase II study evaluating the Company’s ADXS-HPV construct for the treatment of advanced cervical cancer. The study is sponsored by the GOG with the majority of funding from the National Cancer Institute.
The GOG study is in a patient population similar to the ongoing 110 patient study that Advaxis is conducting in India. Both studies will assess safety and efficacy in cervical cancer patients who have not responded to conventional cytotoxic treatment and whose cancer has metastasized and resumed growth.
This study will complement the Company’s cervical cancer trial in India and, upon completion of enrollment for both trials, result in a total of over 170 patients in Phase II cervical cancer program.
Balance Sheet has been Boosted through Additional Financing
On December 30, 2011, Advaxis entered into a definitive Convertible Notes Purchase Agreement with certain accredited investors, for the purchase of the aggregate principal value of approximately $1.2 million of Convertible Promissory Notes for an aggregate purchase price of approximately $1.0 million.
The Notes have an original issue discount of 15% and mature on the one year anniversary of the issue date. Under the terms specified therein, the Notes are convertible, in whole or in part, into common stock at a conversion price of $0.15. However, except as otherwise provided in the Notes, only 85% of the initial principal amount of each Note is convertible at any time after issuance and the remainder is convertible at maturity.
In connection with the Agreement, the Company issued a warrant to each investor to acquire up to such number of shares of Common Stock equal to 50% of such number of Conversion Shares, issuable upon exercise of the Note issued to such Investor as of the Closing Date with an exercise price of $0.15. The warrants will expire in three years.
In October, 2011, Advaxis purchased Convertible Promissory Notes with principal value of approximately $2.3 million for an aggregate purchase price of approximately $2.0 million. Investors include certain accredited investors as well as the CEO and the CFO of the Company.
The Notes purchased in the offering were paid for in cash or, with respect to Notes acquired by Advaxis Chairman/CEO Thomas A. Moore, in exchange for the cancellation of $400,000 of outstanding indebtedness owed by the Company.
As of October 31, 2011, Advaxis had $1.1 million in cash. Plus the recent proceeds from the sale of new notes, Advaxis should have a cash balance of about $2 million.
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