Batu Biologics announced today FDA development plans for its patent-pending lead product, ValloVax™, a cancer immunotherapeutic "vaccine" that specifically targets the tumor blood vessels (endothelium). The vaccine is a "therapeutic vaccine" in that it will be used to stimulate the immune system of patients that already suffer from cancer. This is in contrast to conventional vaccines which are prophylactic, meaning that they are administered to prevent onset of disease.
ValloVax™ is comprised of isolated cells from the placenta, which are highly characterized and treated with a proprietary set of compounds to increase the immune system's ability to respond to the vaccine.
"The physician-immunologist Dr. Valentin Govallo used his vaccine to treat over one hundred patients, most with incurable cancers, and reportedly had over 60% of his patients survive 10 years or longer. Subsequent to the publication of these data in his book, Immunology of Pregnancy and Cancer (Nova Publishers, 1993), numerous clinics outside of the US started to offer this therapy to cancer patients, with anecdotal reports of remissions in end stage cancer patients," said Samuel Wagner, CEO of Batu Biologics. "Given advances in the field of immunotherapy of pregnancy and cancer, many of Dr. Govallo's hypotheses regarding similarity between pregnancy and cancer were demonstrated correct. Unfortunately, no legitimate attempt has been made to manufacture this product in a manner consistent with FDA requirement."
The company plans to achieve the following milestones
1. July 2014: Isolation, characterization of active cells in the placental preparation responsible for induction of anticancer immunity
2. September 2014: Animal efficacy experiments completed to identify optimum vaccine formulation.
3. December 2014: Completion of animal safety studies.
4. Q1 2015: Filing of IND to FDA for treatment of non-small stage lung cancer
"There are several paths that we are engaging to accelerate development of ValloVax™ , including leveraging existing data developed both by Batu Biologics, as well as an international collaborative network that we have established," stated Andy Kim, VP of Scientific Research of Batu Biologics. "Currently the strongest evidence points to Govallo's Vaccine, termed VG-1000, as working through inhibiting production of new blood vessels in tumors. We are aggressively pursuing this hypothesis as an underlying theme in our developmental experiments."
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