Tuesday, August 20, 2013

Batu FDA Biologics development plans reports for immunotherapeutic cancer vaccine ValloVax

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Batu FDA Biologics development plans reports for immunotherapeutic cancer vaccine ValloVax -

Batu Biologics announced today development plans from the FDA for its product patent pending lighthouse , ValloVax "vaccine" immunotherapeutic cancer that specifically targets tumor blood vessels (endothelium). The vaccine is a "therapeutic vaccine", in that it is used to stimulate the immune system of patients already suffering from cancer. This is in contrast to conventional vaccines, which are prophylactic, which means that they are administered to prevent onset of the disease.

ValloVax consists of isolated cells from the placenta, which are strongly characterized and treated with an exclusive set of compounds to increase the immune system's ability to respond to the vaccine.

"doctor-immunologist Dr. Valentin Govallo used its vaccine to treat more than one hundred patients, most curable cancers, and would have had more than 60% of patients survive 10 years or more. After publication of these data in his book, Immunology of pregnancy and cancer (Nova Science Publishers, 1993), many clinics outside the United States began offering this therapy for cancer patients, with anecdotal remissions reports in patients suffering from end-stage cancer, "said Samuel Wagner, CEO of Batu Biologics." the progress in the field of immunotherapy of pregnancy and cancer, several assumptions Dr. Govallo concerning the similarity between pregnancy and cancer have been proven correct given. Unfortunately, no legitimate attempt was made to manufacture this product in a manner consistent with the requirements of the FDA. "

The company expects to achieve the following steps

1. July 2014: Isolation, characterization of active cells in the placental preparation responsible for the induction of cancer immunity

2. September 2014: animal experiments efficiently conducted to identify the optimal formulation of the vaccine

.. 3 December 2014 :. Conducting animal safety studies

4. Q1 2015: Deposit IND to the FDA for the treatment of non-small lung cancer stage

"There are many paths we are committed to accelerating the development of ValloVax , including getting existing data developed by both Batu Biologics, as well as an international collaborative network that we have established, "said Andy Kim, vice president of scientific research Batu Biologics. "Currently, the strengths of evidence to Govallo vaccines, called VG-1000, working by inhibiting the production of new blood vessels in tumors. We aggressively pursue this case as an underlying theme in our development experiences. "


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