Lovaxin C is administered as in IV infusion that is only invasive to the extent that it requires an IV line be placed.
1 — Please explain some of the risks and benefits associated with as Loop Electrosurgical Excision Procedure (LEEP).
LEEP is quick, inexpensive, and has a high success rate of over 90%. The failings LEEP include incomplete removal of abnormal tissue and possible disease progression to invasive cancer, hemorrhage, infection, pre-term delivery, low birth weight, cervical stenosis and restenosis, pPROM in subsequent pregnancies, and infertility. Unlike surgery, Lovaxin C is directed against the underlying etiology of CIN and has the potential to provide long lived protection from HPV induced disease.
2 — Describe what’s involved in your less invasive approach to CIN. How successful has Lovaxin C been to date? What further testing is being conducted?
Lovaxin C is administered as in IV infusion that is only invasive to the extent that it requires an IV line be placed. It was assessed in a Phase 1 trial of recurrent cervical cancer in patients with late stage disease who had failed multiple therapeutic regimens. Of 13 evaluable patients, four patients experienced tumor reductions. At the time of this writing four patients are still alive as we approach two years following their treatment. In that first-in-humans trial patients were treated as in-patients. In our next Phase 2 trial in Cervical Intraepithelial Neoplasia we will be using and out-patient regimen. We are currently developing a Phase 2 protocol in CIN 2/3, the Gynecologic Oncology Group at NCI has agreed to do a trial looking at Lovaxin C combined with chemotherapy in recurrent cervical cancer which is currently in development. Another NCI funded trial in recurrent cervical cancer is being developed looking at Lovaxin C and radiotherapy. And a group in the UK is looking at fielding a trial of Lovaxin C and surgery and chemotherapy in head and neck cancer.
3 - Any additional information for our readers?:
Unlike Gardasil, which is a prophylactic vaccine for HPV and which is not effective in women already infected with HPV or in women with cervical cancer, Lovaxin C is intended as therapy for women with cancer. Unlike Gardasil, which will prevent HPV infection prior to exposure, we are testing Lovaxin C to determine if it can get rid of HPV after patients are infected and provide protection from reinfection.
Dr. Rothman joined Advaxis Inc. in March of 2005 as Vice President of Clinical Development. Prior to that between 2001 and 2003 he and a colleague purchased a 180 bed hospital from the University of Ohio system, sold it to an African Chief, and moved the facility to Ibaden Nigeria. From 2002 to 2005 Dr. Rothman was Vice President and Chief Technology Officer of Princeton Technology Partners.