Anticipated accomplishments in the next 15 months
related to prostate cancer drug development and vaccine production:
● Synthesis of the Drug under GMP Conditions fit for human use.
● Confidentiality agreements signed between AVT and Dr. Reddy’s (India), Frontage New Jersey and in Gdansk/Lodz Poland. All of these facilities are FDA Approved and inspected. We are Awaiting Funding to institute the contracts. Once the synthesis is completed additional short term animal toxicology studies to be completed. These studies will include pharmacokinetics and minimal toxicity evaluations. Once completed will initiate phase I clinical studies.
● Professor Jerzy Konopa of the Technical University of Gdansk is a 20 year old collaborator of Dr. Tiwari and is listed as co-inventor of Capridine is on board as an Advisor. Dr. Konopa is regarded as the Worlds #1 scientist in the chemistry of this class of drugs with over 45 years of experience in only these class of drugs. AVT has exclusive world wide rights to ALL Drug resulting from this discovery with 2 AWARDED patents in US, 19 countries of Europe, Mexico, Israel and Canada. TWO Patents Awarded for Vaccine and ONE pending for US. Awaiting funding so that all of the Patents can be Validated
● Application to the FDA for approval of the drug for human use is complete except for the Chemistry ,animal pharmacology and Manufacture (CMC) Section which will be inserted as soon as the Synthesis is done
● Human trial to be initiated in multicenter trials across the United states (Cancer Institute of New Jersey, Drs, Bertino and Banerjee as lead investigators), India (Dr. Purvish Parikh, Chief of Oncology Tata Memorial Mumbai, India). Dr. Bertino is the Director of CINJ, Scientific Advisory Board Member of AVT).Dr. Parikh is long term (over 30 years) friend and collaborator of Dr. Tiwari. Further Dr. Mittelman, President of AVT and President of the Oncology Group New York Chapter has access to a consortium of clinical trial investigators in Canada and Europe and New York. All of these simultaneous activation of trials is fund related and initiation of these contact is awaiting funding
● Peptide vaccine for prostate cancer will be synthesized during the same time using the same facilities as the drug, initial contact have been made
● The Drug value (Prostate Cancer Efficacy alone) alone at the end of the trial is expected to be somewhere in the range of $150 - 175 million if sold to a pharma company. If you add Colon Cancer the value can be at least doubled. The Peptide vaccine is separate. The peptide technology once validated can be extended to infectious diseases which have at least three times the market than Prostate and Colon Cancer.
In summary, the Drug, vaccine technology, the AVT Team, Advisors and Collaborators are all in place ready to take position and are awaiting funding. The liason with Pharma is also well reconstructed with personal contacts of Drs. Mittelman and Coleman who have been dealing with large pharma in various capacities for over 30 years. Mr. Pollock with a keen business sense and understanding of AVT products will be able to create and add highest value for AVT investors at all steps