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James K. Bashkin, D.Phil.
Department of Chemistry and Biochemistry
Program in Biochemistry and Biotechnology
University of Missouri-St. Louis
1 University Boulevard
St. Louis, Missouri 63121
July 12, 2016
To whom it may concern
RE: Discoveries by Dr. Justice Obi about treatment and cures for HPV and associated diseases
Before I comment on the wonderful and exciting discoveries made by Dr. Justice Obi in the area of treating HPV-derived disease, both high- and low-risk, I will give a brief explanation of my background. I entered college at age 15 and graduated at age 18 from the University of California- Irvine with a degree in Chemistry and nearly a second degree in Biology. During my undergraduate time at Irvine, I received two fellowships for research, one from the Dean of Physical Sciences and one from the President of the entire University of California System. I then entered the doctoral program at the University of Oxford, U.K. and worked under the supervision of Professor Malcolm L.H. Green, FRS. After obtaining my doctorate (D.Phil.) in 1982, I joined the laboratory of Professor Richard H. Holm at Harvard University, where I worked as both postdoctoral fellow and NIH postdoctoral fellow. In 1985 Monsanto recruited me to join its Corporate Research department, where I began my independent career. During this first industrial sojourn, I maintained my interest in academic-style research and published and patented on a variety of topics. These topics included (1) new electrochemical reference electrodes; (2) wholly-synthetic ribozyme mimics designed to act as catalytic antisense drugs; and (3) a new industrial process for the production a component of automobile tires- the new process eliminated massive amounts of pollution and as now practiced worldwide. This process received both Monsanto’s highest award for science and the Presidential Green Chemistry Challenge Award.
In 1991 I became an Assistant Professor of Chemistry at Washington University in St. Louis, where I was also a member of the Biomedical Sciences Program. There, I pursued ribozyme mimics and the detailed mechanism of RNA transesterification and hydrolysis while avoiding simple chemical models, working with RNA itself. In 1999 I returned to Monsanto to head a new program in Gene Chemistry. This program was a large effort, with staff technicians and many Ph.D. scientists. The company rapidly merged with Pharmacia & UpJohn, and later was acquired by Pfizer. We reported a key finding that showed how to control the uptake of pyrrole-imidazole polyamides in cancer cell lines that had multidrug resistance induced. I also started working on HPV during this time.
In 2003, I left Pfizer and co-founded NanoVir, LLC, which was devoted to fighting highrisk HPV. NanoVir received a Roland R. Tibbetts award as one of the top 50 Federallyfunded companies in 2006; I was and remain its Director of Chemistry. We received approximately $10 million in NIH funding and discovered and carried out preclinical development on several novel classes of anti-HPV compound. I was appointed Professor of Chemistry and Biochemistry at the University of Missouri-St. Louis in 2011. I have published 7 papers on anti-HPV compounds and their mechanism, and have 5 issued US patents in this field. Many related papers have also been published by my group.
Earlier this year I was contacted by Dr. Obi, who wished to share data with me to obtain my independent opinion of his results. I have reviewed clinical data from China, data from the esteemed laboratory of Dr. Tom Broker at the University of Alabama- Birmingham, data from The Feinstein Institute for Medical Research, and data from offlabel studies with patients conducted by Dr. Obi. There were several things that frankly stunned me about the wonderful results presented by Dr. Obi. I mention these in no particular order because they are all of great importance. First was the efficacy observed at such a wide range of disease stages. Second was the efficacy observed for both high- and low-risk forms of disease/virus. Third was the nature of the active pharmaceutical ingredient (API), one already in use worldwide at much higher doses than required for HPV treatment. Fourth was Dr. Obi’s creativity in formulating the API for oral, vaginal, anal, penile, and other uses as a mouthwash, douche, and cream. Fifth was the set of patient reports from individuals who had been distraught from illness and who were now leading normal lives where HPV-derived disease no longer played a role.
Because of this overwhelming evidence for Dr. Obi’s inventions, I became convinced that he had the solution to one of the greatest health epidemics the world has ever faced. I receive many emails and phone calls from people suffering from various HPV-derived diseases. I am not a medical doctor and am not licensed to give medical advice. However, with that caveat made clear, I have informed people about Dr. Obi, and all whom he has treated, he has treated successfully.
Dr. Obi’s discovery ranks as the top unknown medicinal chemistry and pharmaceutical discovery in the world. It needs to be commercialized to save the many hundreds of thousands of lives, ultimately even more, that it can save worldwide, and the approximately 5,000 lives it will save in the U.S. every year. I give this discovery my full endorsement: scientifically and morally, it must be pursued.
James K. Bashkin, Professor
Daniel Mark Sigel, M.D. MS
Department of Dermatology
University Hospital of Brooklyn College
of Medicine School
of Graduate Studies
College of Nursing
College of Health Related Professions
July 13, 2016
To Whom It May Concern
Re: Obinaquine Gel for Human Papilloma Virus Infections Dear Sirs/Madams:
I have been asked by Dr. Justice Obi to describe my experience with Obinaquine gel. I recently had an individual with an HPV type I plantar wart that had been persistent for many years, having undergone prior unsuccessful treatment other physicians with surgical excision, thermal destruction, cryosurgery and a variety of topical therapies including 5-fluorouracil, salicylic acid and imiquimod. I performed a biopsy to confirm that this was indeed wart and not a squamous carcinoma. After that I pared down the wart with sharp debridement to the bleeding points that represent the junction of the wart with underlying papillary dermis and had him apply the gel under occlusion as directed by Dr. Obie. When he returned for a follow-up visit I was able to further debride dead tissue that the patient noted was painless. In a few weeks the patient was free of disease and remains so to this day.
While the mechanism action of this gel is not yet clear, I personally am quite excited by the potential of this drug and believe that it needs to be studied in all kinds of HPV associated diseases including anogenital warts, palmar warts, facial wart, oral warts and possibly all warts and also it might have value in other HPV related diseases including malignancies of the cervix, vagina, rectum, perianal area, throat, esophagus, head, neck, penis, vulva and periungual areas. If you have any questions and would like to speak with me please feel free to contact me at my email: cyberderm©dermsurg.org.
Daniel Mark Sigel, M.D. MS
Clinical Professor of Dermatology
SUNY Downstate Medical Center
Former President, American Academy of Dermatology
State University of New York
Downstate Medical Center
450 Clarkson Avenue, Box 46
Brooklyn, NY 11203-2098
Phone 718 270-1229
Fax 718 270-2794
Thomas R. Broker
“I have been asked by Justice E. Obi to provide a declaration regarding certain issues that I understand are relevant in the context of the examination of U.S. Application No. 13/932,445 (“445 Application” hereinafter). I understand that his Declaration will be submitted to the United States Patent and Trademark Office in the context of the examination proceedings of the ‘445 Application. I have reviewed the ‘445 application with regard to what the application describes and teaches an artisan of ordinary skill relative to the state of the art as of July 3, 2012
Based on my experience with running in vivo and ex vivo HPV assays in the last 10 years, it is my opinion that the claimed topical treatment is a potential game changer in the market. The efficacy of the claimed topical treatment should have a very positive effect by curbing the current national and global epidemic of HPV infections.
I declare that all statements made herein of my own knowledge are true and that all statements made on information and belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code, and that such willful false statements may jeopardize the validity of the application or any patent issued thereon.
Thomas R. Broker, PhD
Obinaquine was tested at the Feinstein Institute for Medical Research in the Laboratory of Dr. Bettie M. Steinberg at the request of Dr. Obi. Dr. Steinberg is the Chief Scientific Officer of the Institute and Dean of the Elmezzi Graduate School of Molecular Medicine and Chair of the Department of Molecular Medicine, Hofstra North Shore-LIJ School of Medicine, Manhasset, NY. As the attached report shows, no toxicity was seen to HPV6+ and HPV- laryngeal keratinocytes up to 25 ug/mL, and both HPV6+ and HPV- cells were killed by Obinaquine at 250 ug/mL doses in cell culture.