Advaxis is a clinical-stage biotech company with a centralized focus on its candidate, ADXS-HPV, which is being evaluated in five clinical trials for HPV-associated diseases: recurrent/refractory cervical cancer, locally advanced cervical cancer, head and neck cancer, and anal cancer.
In its recent 2013 business outlook, Advaxis said it is pursuing two overarching objectives for 2013 – to advance ADXS-HPV toward registration and development, and to strengthen its financial position – paired with supporting clinical regulatory objectives which are to analyze phase 2 data, proceed with and finalize its clinical plan, and to consult with regulatory authorities to advance ADXS-HPV to registrational trials.
In 2012 the company began laying serious groundwork to achieve its mission for 2013, securing a $10 million committed equity line, slashing its debt by 80 percent, and achieving proof of concept for ADXS-HPV.
So far this year, the company has dosed its first patient in a phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer .This study expands the clinical investigation of ADXS-HPV to now a third tumor type, following cervical cancer and head and neck cancer.
The company also recently took a step toward its first licensing deal, announcing that it is working to establish a formal agreement with FusionVax, Inc., a private Taiwan-based biopharmaceutical company developing immunotherapies for the treatment of HPV-associated cancers. Upon final agreement, Advaxis will exclusively license the rights to ADXS-HPV to FusionVax for the Asia territory, exclusive of India, for all indications.
For the remainder of 2013, Advaxis is on deck to achieve several expectations:
• Announce CIN 2/3 mid-dose cohort 2 data (Q2)
• Announce 12-month survival data from India study (Q2)
• Announce final phase 2 cervical cancer results (H2)
• Initiate phase 2 high-dose cohort 3 CIN 2/3
• Complete safety portion of ADXS-cHER2 phase ½ canine study (year-end)
• Report preliminary data from canine study
In the first six months of 2014, Advaxis anticipates that it will be prepared to file and IND with the FDA for ADXS-PSA.
For more information visit www.advaxis.com
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