CytoDyn Inc. (CYDY) Pioneering New Weapons in the War against HIV

The scourge of HIV/AIDS surged to the forefront of American consciousness in 1980 when the first case was reported to the Centers for Disease Control and Prevention. Initially thought to be transmitted solely through homosexual liaisons, it was soon realized that the disease could be passed through the bodily fluids of any person infected with the human immunodeficiency virus (HIV). Contrary to early myths, HIV cannot be contracted by shaking hands or hugging, or by touching dishes or toilet seats used by infected people. It doesn’t spread through the air, through insect bites or through sweat, saliva or urine. HIV is only spread through sexual intercourse, sharing needles, or by a mother passing the disease to her child at birth, and it is transmitted through blood, semen, pre-seminal fluid, rectal fluids, vaginal fluids or breast milk.

Urban legend purports that HIV started in the 1980s, but that was only when the public first became aware of HIV and when it was officially recognized as a new health concern. The origin of HIV has been a topic of debate since the virus was first identified. Scientific research now estimates with some certainty that in the early 1900s a simian form of HIV was transmitted to humans in Africa as a result of chimps being killed and eaten, or by chimp blood getting into cuts on people in the course of hunting.  The virus morphed within its new human host and became HIV-1, which went on to become the pandemic strain of HIV that has killed over 35 million people worldwide.

The virus attacks the immune system and destroys specific white blood cells (CD4 cells). The virus also makes copies of itself inside these cells, and, as it destroys more CD4 cells and makes more copies of itself, it completely cripples a person’s immune system. In late stage HIV infection, acquired immune deficiency syndrome (AIDS), there is severe loss of the body’s cellular immunity and a dramatic decrease in resistance to infection and malignancy. Impossible to fight off disease, HIV led to certain death.

Researchers scrambled to understand the disease and find effective treatments. In 1986, the first antiviral drug to inhibit HIV replication was approved by the FDA. Other drugs followed to limit production of the virus in CD4 cells. However, these mono-therapy drug treatments were only partially proficient and curiously exhibited differing degrees of efficacy among different patients. Researchers soon realized that HIV could quickly develop resistance to any single medication and, soon after, they developed combination drug therapies that suffocated mutated forms of HIV before they could rampantly replicate.

This combination of HIV medicines, antiretroviral therapy (ART), prevents HIV from multiplying and reduces the amount of HIV in the body. Less HIV in the body protects the immune system and helps prevent HIV infection from advancing to AIDS. Today, highly active antiretroviral therapy (HAART) is the primary regimen for treating immune deterioration in HIV patients. Weakened but still incurable, the HIV virus remains in the body and requires diligent daily treatment, and, over time, efficacy even diminishes in some patients. While HAART has transformed HIV from a deadly disease to a chronic one, it has several major difficulties, namely, resistance, compliance, side effects, and short- and long-term toxicity.  These four problems are the primary reasons why there are currently only about 35% of the HIV patients in the U.S. with a suppressed viral load (which is typically defined as a HIV level of less than 40 copies per milliliter of blood). It is important to note that if a HIV patient has a suppressed viral load the rate of transmission is almost zero.

CytoDyn Inc. (OTCQB: CYDY) is pioneering the development of new weapons in the continued war against HIV.  Focused on improving the quality of life for HIV patients, the company is developing new therapies to address the growing number of treatment challenged HIV patients with its clinical development of humanized monoclonal antibodies for the treatment of HIV infection. CytoDyn is at the forefront of developing this category of drugs and has progressed to the late stages of clinical development.

The company’s leading monoclonal antibody drug candidate, PRO 140, is a therapeutic anti-viral agent that is currently being evaluated in two concurrent Phase III clinical trials for the treatment of patients already infected with HIV. With less frequent dosing and minimal side effects and toxicity, PRO 140 is a new class of HIV therapeutic that protects healthy cells from viral infection. Recognizing the potential, CytoDyn recently filed a request with the FDA to assign PRO 140 a Breakthrough Therapy Designation, which would differentiate PRO 140 from all other currently used HIV treatments.

The war against HIV is far from over, but with the development of new drugs like CytoDyn’s PRO 140, each individual battle takes us a step closer to complete victory.

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