THE MARKET

     HIV is a chronic disease affecting an estimated 36.9 million individuals worldwide.  Approximately 2 million people are newly infected each year with HIV and 1.2 million die each year with over 7% of this number being children. Approximately 700 new infections occur daily through maternal to child transmission (MTCT).  Despite potential life threatening complications, ARVs are the only approved medications to treat neonatal infection.  Without treatment, 1/3 of these infants will not live to see their first birthdays and half won’t survive until their second. 
  
     In 2014, 15 million people were taking antiretroviral therapy for HIV.
     In North America, 1.4 million individuals are infected with HIV/AIDS and over 87,000 are newly infected each year. Those infected by HIV are primarily treated with anti-retroviral (ARV) chemotherapy drugs that only suppress the symptoms of the virus.  ARV drugs also spawn drug-resistant strains of the virus that are not treatable with current ARV drugs and thus are lethal.
 
     Modern HIV drugs can keep people healthy for decades, but the costs for HIV treatment  is substantial.
The combined sales value of HIV drugs in the seven major markets (US, Japan and the 5 major EU markets (France, Germany, Italy, Spain, UK) is expected to increase by 40% in the next decade, rising from $11.9 Billion in 2013 to $16.8 Billion in 2022.  The average cost of HIV treatment is $14,000 to $20,000 a year.  The lifetime treatment cost of an HIV infection in the U.S.  is estimated at $379,668 in 2010 dollars.
 
     Globally, only 40% of people living with HIV are receiving treatment, which includes 41% of adults and 32% of children living with HIV. 

THE COMPETITION

     Presently there is no vaccine or active immunization to successfully prevent HIV-infection. There is no cure that eradicates the virus completely once an individual has been infected. Today, the U.S. Food and Drug Administration (FDA) currently has approved anti-retroviral (ARV) chemotherapeutic highly toxic drugs, in three categories, for the treatment of HIV infection. These drugs are highly toxic and cause a huge number of side effects, most significantly liver failure, fever, myalgia, malaise, nausea, vomiting, symptoms suggestive of upper respiratory tract infection, anorexia, rash occurring in about half of cases, fatigue, malaise, insomnia, and depression, to name just a few.
 
     The first class of drugs used to treat patients with HIV includes nucleoside analogues that are synthetic DNA building blocks that act as chemical decoys and prevent HIV replication.  AZT is an example of a nucleoside analogue that functionally inhibits the reverse transcriptase enzyme unique to the family of retroviruses and HIV.  Chemical side effects caused by nucleoside analogues, as evidenced by intolerance and/or induction of abnormal patient blood profiles, occur in some nucleoside analogue recipients, and the medication therefore must be reduced in dosage or completely discontinued.
 
     The second class includes protease inhibitors.  These chemotherapeutic drugs are synthetic substrate molecules that inhibit the proteolytic activity of HIV protease, which is required for viral replication.  Unlike nucleoside analogues represented by AZT, resistance to one protease inhibitor often confers resistance to many others.  For example, when a person becomes resistant to Abbott's Ritonavir, Merck's Indinavir will also become relatively ineffective.  The same cross-resistance is then likely to apply to Agouron's Nelfinavir.  The only slight escape is demonstrated for patients who might first develop resistance to Roche's Saquinavir, wherein resistance confers only one of four mutation steps required to develop cross-resistance to the other protease inhibitors.
 
     Unfortunately, this first step establishes the prerequisite conditions for, and hastens, the eventual development of multi-drug resistant pathogenic “super-viruses” that cannot be stopped or controlled even through using multiple chemotherapeutic drugs, often referred to as  “the cocktail”.  The third and fourth classes of agents currently include a fusion inhibitor—with one drug only being Fuzion® approved in this category—and additional drugs that are newly approved at this time.  These potentially block virus entry into the targeted CD4+ mononuclear cells, and are categorized as entry-inhibitors.  One recent entry inhibitor is represented by Selzentry® (maraviroc), which is produced by Pfizer, that is not effective against CXCR4 tropic HIV isolates, this category of HIV being prevalent in later stages of HIV with progression to full-blown AIDS symptoms.
 
     Integrase inhibitors are represented by Merck’s Isentress® (raltegravir), which prevents the integration of reverse-transcribed production of DNA from HIV viral RNA into the host’s genome.  Isentress must be used in combination with other HIV drugs.  Isentress is not approved for use in HIV-positive children due to its extreme toxicity and side effects.  In many instances, with continued use of the chemotherapeutic medication, viral mutations have been demonstrated to occur within the targeted drug binding site in the virus, a process that then renders use of the inhibitors ineffective, allowing HIV disease progression and death.  Remarkably, Clone 3 antibody’s immunotherapeutic technologies platform has a distinct advantage over the competitors’ chemotherapeutic drugs.  The Clone 3 antibody’s targeted amino-acid sequence (epitope) is an essential component that must remain functional for HIV replication and infection, and is highly conserved (immutable).  The Clone 3 antibody’s neutralization capacity therefore is not diminished because Clone 3 binds to and neutralizes an amino-acid sequence on the viral surface that does not mutate.  The Clone 3 Antibody also neutralizes both categories of HIV primary viruses whether they have tropism(s) for the CCR5 co‑receptor, as well as CXCR4 co-receptor.  Clone 3 antibody is the only biologic with this distinct immunotherapeutic advantage for those currently HIV-infected.  Clone 3 has the potential to prevent viral infectivity from person to person; this has not been achieved by any chemotherapeutic drug combination.
  
CURRENT THERAPHY
       The antiretroviral drug Tivicay, is expected to become the leading integrase inhibitor for the treatment of HIV.  It is expected to generate annual sales of up to $2.1 Billion by 2022 in the US, Japan and five major EU markets (France, Germany, Italy, Spain, UK) equating to 12.6% of the total combined value of these markets.
Tivicay, which was recently approved in the US, had better efficacy than the protease inhibitor Prezista in clinical trials, and comparable efficacy with current integrase inhibitor standard of care Isentress.  This sector of pharmaceutical drugs continues to experience exceptional growth.   
 
     However, the drugs produced are toxic and can only suppress the symptoms of the virus while severely depressing the quality of life.  ARV treatment is known to cause severe damage to organs (including the heart and kidneys), decreases bone-mineral density, results in vitamin D insufficiency and must be administered for life.  Other side effects include: Hypersensitivity reactions, fat redistribution and immune reconstitut8ion syndrome.
 
     Additionally, ARV drugs spawn drug-resistant strains of the virus that cannot be treated by available ARV drugs.
 
Treatment using the Company’s Clone 3 antibody will be superior to current ARV therapy because: (1) it is effective and non-toxic, (2) does not require lifetime use and (3) it is far less costly.  Thus, for the patient, the Clone 3 antibody immunotherapy will be remarkably different -- it will be safer, and provides a much needed immunotherapeutic cure rather than requiring lifelong treatment, and is substantially less expensive.
 
     BioClonetics’ technology addresses the HIV/AIDS pandemic with a proprietary monoclonal antibody immunotherapy that is non-toxic and 100% effective against over 90% of all strains and viral subtypes of HIV-1. This antibody can be used as an immunotherapeutic treatment for individuals with HIV/AIDS and as a prophylactic and therapeutic vaccine to prevent uninfected populations from contracting the virus.
 
     Treatment using the Company’s Clone 3 antibody will be far superior to current ARV therapy for several significant reasons: (1) th therapy will be effective and non-toxic, (2) does not require lifetime treatment, and (3) will be far less expensive.  Thus, for the patient, the Clone 3 antibody immunotherapy will be remarkably different -- it will be safer, provide a much needed immunotherapeutic cure rather than requiring lifelong treatment, and costs substantially less.