Since the discovery of the acquired immune deficiency syndrome (AIDS) in the early 1980s, we have come a long way towards our understanding of the disease that has affected millions of people worldwide. Identifying the human immunodeficiency virus (HIV) as the main agent that causes AIDS certainly paved the way towards discovering and developing more effective treatments. HIV is further classified into two species: HIV-1, which is the main epidemic, and HIV-2, a strain restricted within the regions of West Africa. Today, the standard management of the HIV-1 disease is for patients to go through highly active antiretroviral therapies (HAART).
The main target of HIV-1 when it enters the body is the CD4 cell or T-cell. Once it is infected, the virus starts to replicate itself by binding with the CD4 and integrating with the host's DNA. The symptoms of the disease are flu-like; this is why it can take some time before a patient is positively diagnosed with HIV-1. The virus can even stay dormant for years before it starts attacking the immune system. The introduction of HAART to the market opened the discussion on therapeutic agents that can prevent HIV-1 from compromising patients' health. Protease inhibitors, in particular, are antiviral drugs that in turn bind with HIV-1, thereby remarkably preventing the virus from reproducing. CytoDyn Inc. (OTCQB:CYDY) is a biotechnology company focused on new therapies for combating HIV infection, specifically a powerful HIV-1 inhibitor called PRO 140. It is a humanized monoclonal antibody that effectively blocks CCR5, an HIV co-receptor (R5 strain) that enter the cells of the body upon transmission.
HIV-1 inhibitors play a very crucial part in the success of not just HAART but also monotherapy. Their efficacy is largely exhibited through the growth suppression of the virus while it is at multiple stages in its life cycle. When HIV-1 is unable to attack the remaining healthy cells in the body, the immune system has a bigger chance of fighting the infection. The progress of HIV-1 inhibitors resulted in an increase in number of patients who are responding well to treatment.
Nevertheless, the virus is constantly evolving, capable of resisting and mutating against various drugs. It is imperative that there is continued research of HIV treatments with the aid of constantly evolving technology. CytoDyn is currently at the helm of developing PRO 140, which are humanized cell-specific monoclonal antibodies (mAbs) that act as entry inhibitors. According to Mr. William C. Olson's and Mr. Jeffrey M. Jacobson's study (CCR5 Monoclonal Antibodies for HIV-1 Therapy), mAbs efficiently binds with CCR5, and reduces the HIV-1 RNA levels in infected patient's immune system with no reported toxicity. It is also important to note that mAbs have "demonstrated broad and potent antiviral activity in vitro."
Most of the HIV-1 inhibitors out on the market today have "poor pharmacokinetic properties such as low aqueous solubility, poor membrane permeability, high protein binding, and insufficient metabolic stability." PRO 140 has proven to have a better profile on safety with regards to HIV treatment. It has already demonstrated rapid viral load suppression - the performance of one dose alone is as good as, or perhaps better than, any HIV drug in the market today. CytoDyn believes that PRO 140's new approach to HIV therapy provides an alternative to the current HAART regimen. One big advantage is that there is no need for a rigorous schedule of drug intake, which takes a toll not only on the patients' bodies but in their savings as well. In a landscape of proven and tested HIV treatments, PRO 140 belongs to a new class of HIV/AIDS therapeutics. Based on what CytoDyn has reported so far about their progress, all point toward the possibilities of treating the following kinds of patients: those who have complex concomitant medical requirements, those with poorly tolerate existing therapies, those who are having difficulty adhering to daily drug regimens or whose viruses remain resistant to a lot of drugs. It might also be feasible to treat pre-exposure (PrEP) or post-exposure (NYSE:PEP) prophylactic high risk seronegative individuals, as well as patients with compromised organ function (like HCV co-infection).
To date, the company has received more than $20 million in NIH grants, and has recently reported a commendable success rate in their recent Phase 2B clinical trials. In a conference call with the investment community last October 2014, CytoDyn shared its plans to move forward with Phase 3 of clinical trials. The company firmly believes in the efficacy of PRO 140, and hopes to empower and affect more patients' lives positively in the years to come.
For more information about CytoDyn and PRO 140, visit www.cytodyn.com/drug-pipeline/pro-140.