At the recently held Conference on Retroviruses and Opportunistic Infections at the Washington State Convention Center in Seattle, details of clinical trial results presented by CytoDyn Inc. (OTCQB: CYDY) for its monoclonal antibody, PRO 140, were well received. The UK-based charity, NAM Aidsmap, known for its pioneering work in providing information on HIV/AIDS therapies, hailed the poster presentations on monoclonal antibodies such as PRO 140, noting the promise they hold as long-acting therapies for HIV/AIDS patients with limited treatment options due to drug resistance (http://nnw.fm/dFPp2). PRO 140’s efficacy has already offered hope to a number of HIV positive patients in a series of clinical trials. On behalf of CytoDyn, Dr. Kush Dhody of Amarex Clinical Research presented, in a well-attended special themed discussion, the latest results from the extension study of a Phase IIb trial of PRO 140 as a single agent maintenance therapy for people who had achieved viral suppression on standard combination antiretroviral therapy (ART) and wanted to switch to a treatment with fewer side effects to improve their quality of life and provide simpler compliance.
Antibodies are produced by the body as a first line of defense against pathogens such as viruses and bacteria. Each antibody is uniquely developed to combat a particular antigen, which it then counters by flagging the intruder as such, to be destroyed by microphages, or by neutralizing it. Monoclonal antibodies are artificially produced antibodies that have been cloned from one cell, hence the term “monoclonal”. Being clones, antibodies produced from one cell are identical, and this means that large numbers of a specific antibody can be produced to fight the unique antigens associated with a pathogen.
This characteristic of selectively targeting a pathogen has given antibodies the moniker ‘magic bullets’, since they attack the disease-carrying cells without harming the host. The term was first proposed by German physician Paul Ehrlich, whose insights into the operation of these immunological mechanisms earned him the Nobel Prize in 1908.
PRO 140 is considered one of the most advanced experimental monoclonal antibodies for HIV treatment and has been used in more than 140 HIV positive patients in placebo controlled and open label FDA-approved clinical trials. The drug has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test patients and has been designated a “fast track” product candidate by the FDA.
If approved for commercialization, PRO 140 could face a $20 billion U.S. HIV therapeutics market that is plagued with a number of ills, including difficult dosing schedules, resistance to currently used drugs, and, worst of all, the debilitating toxicity of standard highly active antiretroviral therapy (HAART). PRO 140 has been shown to address the weaknesses of HAART with no serious side effects, hardly any toxicity and no drug resistance when self-administered as a dose-a-week subcutaneous injection. Despite advances in the prevention and treatment of HIV/AIDS, the scourge still afflicts ‘more than 1.2 million people in the U.S.’, according to the Centers for Disease Control and Prevention (http://nnw.fm/b5LWn). With PRO 140, CytoDyn is offering the hope of a longer and richer lifespan to many of those.
CytoDyn is a biotechnology company focused on the clinical development and commercialization of humanized monoclonal antibodies for the treatment and prevention of human immunodeficiency virus infection.
For more information, visit www.CytoDyn.com
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