AV Therapeutics Inc. decloaked in late December by merging with a public shell company. It is developing a chemotherapy candidate, capridine, that has been shown in preclinical models to have activity against prostate and colon cancer, with plans to launch Phase I trials in the second quarter of 2014.
“We’ve had financing from a group of individuals – four major investors in our company,” AV CEO Abraham Mittleman told BioWorld Today. “We’re looking for partners. We’ve had some inquiry by one of the larger pharmaceutical companies,” he said, adding that AV expected to meet with that company after the holiday to discuss potential terms.
The New York-based company’s early funding totals more than $6 million, and includes contributions by the National Institutes of Health and the Department of Defense.
AV, also known as Advanced Vaccine Therapeutics, was founded about 10 years ago, according to Mittleman, with a project to develop cancer vaccines, focusing on finding out how to break immune tolerance. Initially, AV’s research focused on developing synthetic peptides using chaperone protein complexes.
Prostate cancer is the most common type of cancer affecting men in the U.S., with annual expenditures exceeding $15 billion. Current standard chemotherapies have limited efficacy for metastatic disease, and are associated with severe bone marrow toxicity and poor tolerance.
Dendreon Corp.’s Provenge (sipuleucel-T) was approved in 2010 for metastatic hormone refractory prostate cancer, but its sales have been consistently disappointing since then. AV said that Provenge is “expensive and has minimal efficacy,” leaving the door open for other competitors in the prostate cancer marketplace.
Capridine is a nitro-acridine drug with documented activity against prostate, colon and other cancers, according to AV. It is active against hormone-dependent and hormone-independent prostate cancer xenografts. Animal studies suggest a broad therapeutic dose range.
AV’s development plan for capridine includes GMP drug manufacture and formulation, stability testing, toxicity testing, pharmacokinetic and pharmacodynamics studies, investigational new drug application and Phase I/II trials.
AV’s second most-advanced product is the Pros-Vax synthetic peptide vaccine, which mimics cancer proteins and recruits the patient’s immune response to multiple cancer-specific proteins. AV said preclinical studies for Pros-Vax are complete, and it contended the vaccine may eliminate micrometastatic and residual disease, preventing recurrence.
“We’re at the moment where GMP production is starting,” Mittleman said. “We hope to be in humans in nine months.”
Mittleman said that Pros-Vax is interesting because it’s a synthetic peptide that is not patient-specific. That is in contrast to Provenge, which is a complex multistep treatment involving removal of blood by apheresis, processing and then reinfusing the patient. “It’s very expensive, with limited benefits,” Mittleman said.
AV is positioning Pros-Vax for the early stages of the disease, after surgery and radiation.
In terms of composition of the vaccine, Mittleman said that the company has been looking at two separate peptides, and “both were effective.” Pointing out that some current vaccines such as pneumonia vaccine, contain 20 different proteins, he said, “We’re going to be testing the hypothesis of multiple vs. single peptides and see what happens with recurrence.”
Another question to be answered for Pros-Vax is schedule of administration, whether it should be a once-monthly therapy, or something more like once every six months.
The market for AV’s two products totals about $1 billion for the drug and $300 million for secondary prevention of prostate cancer in the U.S. alone, according to AV. Company executives contended that capridine may be applicable as an adjunct to existing chemotherapy regimens to reduce toxicity and increase efficacy against cancer.
There are plans to develop capridine internally through Phase I/II testing before bringing in a partner, depending on available capital.
AV Therapeutics (OTCQB:AVTH) just started trading on Jan. 2 and closed Wednesday at 60 cents.