Nestled on the north bank of the Columbia River in the State of Washington is the city of Vancouver, home to CytoDyn Inc. (OTCQB: CYDY). A publicly-held biotech company, CytoDyn manages its efforts to improve the lives of men and women with the human immunodeficiency virus (HIV), focusing its attention on developing new therapies that offer flexibility and freedom to members of this global community.
With its lead clinical drug candidate, PRO 140, CytoDyn is aiming to offer the next class of antiviral agents for the treatment of HIV. The drug, a monoclonal antibody, is designed to block HIV from infecting immune cells, and it belongs to a new class of HIV/AIDS therapeutics because it seeks to protect healthy cells from viral infection. PRO 140 also has additional potential benefits that differentiate it from existing HIV treatments, including less frequent dosing and minimal side effects and toxicity.
PRO 140 is presently in two Phase 3 clinical trials, which are evaluating its efficacy as an adjunct therapy to current HIV treatments and as a monotherapy treatment for the virus. The pivotal combination therapy Phase 3 trial began in October 2015, and the company expects this trial to lead to PRO 140’s first approval for HIV patients. In the grand scheme of things, PRO 140 is meant to replace pills such as Gilead’s Viread and Atripla and, so far, has repeatedly proven to be a more convenient experience with almost no side effects for a sub-population of R5 HIV-infected patients.
In catering to the needs of people who are living with HIV, CytoDyn is tackling a growing market with an estimated size of $20 billion. Within this space, the company sees a strong opportunity for PRO 140 to serve as an alternative or additional option to current therapies. Although existing therapies seem to work fine with most HIV patients, the quality of life is lacking due to toxicity (short and long term) and side effects, while, in several clinical trials previously conducted on PRO 140, the product was generally well-tolerated and no serious drug-related or dose-proportional adverse events were identified. Rather, the results of these studies ascertained that PRO 140’s antiviral activity was fast, powerful, drawn-out, dose-dependent, and statistically significant following a single dose.
To learn more about this biotech company’s competitive advantage, visit www.CytoDyn.com
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