CytoDyn, Inc. (CYDY) Expects FDA Approval for PRO 140 in HIV by Q4 2019, $500M Revenue Forecast for 2020

• PRO 140 has FDA fast track designation that allows accelerated approval
• The drug protects healthy cells from HIV infection by binding to CCR5 cellular co-receptor
• Market for PRO 140 as a single agent therapy projected at about $4 billion annually
• CYDY recently initiated its first cancer trial in triple negative breast cancer, targeting an unmet medical need

CytoDyn Inc. (OTCQB: CYDY), a biotechnology company focused on the development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of Human Immunodeficiency Virus (HIV), expects to gain final FDA approval for its HIV treatment, PRO 140, by the fourth quarter of 2019, with market availability estimated to follow by 2020.

“We do have a rolling submission with the FDA,” Nader Z. Pourhassan, Ph.D., President and CEO of CytoDyn, said in a recent interview (http://ibn.fm/5mOd9) with Uptick Newswire. “So, we can submit as we get each module ready. By the end of the first quarter of 2019, we should have all of our BLA modules submitted to the FDA. If we do, our fast track designation for PRO 140 allows us to have accelerated approval which is 6 months.”

Leronlimab (PRO 140) is part of a new class of HIV drugs that protects healthy cells from infection by the virus. It’s a humanized IgG4 monoclonal antibody that binds to CCR5, a cellular co-receptor with multiple roles including implications for HIV infection, tumor metastasis and immune signaling. Less frequent dosing, minimal side effects and hardly any toxicity are among multiple potential benefits that distinguish PRO 140 from HIV treatments in current use.

“Our product is a simple, one dose per week and it’s a simple injection,” Pourhassan continued. “This is once per week, self-administered at home. They can forget about their HIV for the rest of the week.”

The HIV co-receptor CCR5 plays a key role in the ability of HIV to enter and infect healthy T-cells. PRO 140 blocks the CCR5 receptor and prevents viral entry. Results of clinical trials so far have shown that PRO 140 has no negative affect on normal immune functions mediated by CCR5. There have been no drug-related SAE’s in the roughly 700 patients who have taken it. Phase 3 human clinical trials have shown that PRO 140 can significantly reduce viral burden in patients infected with HIV. The company is also conducting a phase 3 investigative trial with PRO 140 as a once weekly single agent therapy for HIV patients. If approved as a monotherapy it could replace the current standard of care, called Highly Active Antiretorviral Treatment (HAART), for certain patients.

HIV weakens the body’s immune system by attacking the T-cells, which keep the body protected against infections and some cancers. The World Health Organization reports that 1.8 million people were newly infected with HIV in 2017 (http://ibn.fm/B5YkW). Globally, nearly 37 million people live with HIV, which has already claimed 35 million lives. While there is no cure for HIV infection, effective antiretroviral (ARV) drugs can control the virus and help prevent transmission so that people with HIV can enjoy long and healthy lives. The potential market size for PRO 140, when used as an anti-viral therapy in combination with a patient’s current HIV treatment, is projected at $1.2 billion annually. The annual market for PRO 140 used as a single agent monotherapy is estimated at about $4 billion.

CytoDyn recently announced that it has a green light from the U.S. Food and Drug Administration to conduct a clinical trial with PRO 140 as a treatment for patients with metastatic triple negative breast cancer (TNBC). TNBC is an aggressive cancer with limited treatment options because of a lack of targeted therapies (http://ibn.fm/QG0qs).

For more information, visit the company’s website at www.CytoDyn.com

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