CytoDyn Inc.’s (CYDY) New HIV Treatment Could Bring a Paradigm Shift in HIV Therapy

• PRO 140 requires one dose a week, rather than daily pills
• Treatment has shown hardly any side-effects in clinical trials, while current HIV therapies may cause mild to severe side-effects
• CytoDyn’s treatment is simple for patients to administer with hardly any toxicity

Significant advantages of PRO 140, CytoDyn Inc.’s (OTCQB: CYDY) viral-entry inhibitor, over drugs currently used in HIV treatment therapies have been reported, namely showing little if any toxicity or side-effects in treated patients to date, ease of administration (once weekly dosing) and a lack of HIV resistance developing to the treatment. Although there are several promising HIV therapies currently in development or new on the market, from companies such as Gilead Sciences, Inc. (NASDAQ: GILD), GlaxoSmithKline plc (NYSE: GSK), Johnson & Johnson (NYSE: JNJ) and Merck & Co., Inc. (NYSE: MRK), none are weekly self-administered sub-cutaneous injections in phase 3 development.

Patients on current leading therapies often struggle with treatment compliance due to the complexity of treatment regimens and sometimes high number of pills they must take every day. Non-adherence to current therapies can have major consequences for patients, as even one missed dose may cause the virus to begin multiplying in their bodies, leading to potential resistance against the therapy, according to experts.

In addition, highly active antiretroviral therapies (HAART) on the market at present can cause mild to severe adverse effects among many patients. Current market leaders are striving to deal with the compliance issue by developing treatments that simplify treatment regimens and which have fewer toxic effects on patients.

There are several factors which may make PRO 140 a popular therapy among patients. While on current treatment regimens, a patient who misses even one dose may face immediate consequences, with his or her HIV viral load increasing. However, PRO 140 in a combination therapy could allow a three-day grace period during which patients could suffer no ill effects from missing a dose. PRO 140 requires just one weekly injectable dose, which could also make it an attractive prospect for many patients who struggle to take pills every day.

Additionally, some HAART treatments consist of multiple pills per day, which can be complicated to administer, as they rely on a combination of different medicines, each of which inhibits HIV in a different way but must often be taken at an exact time, several times a day. A large amount of tweaking and adjustment may be required to find a therapy which works for a given patient. In contrast, PRO 140 is designed as a single-agent treatment or “monotherapy.”

Importantly, PRO 140 has not caused any treatment-related serious adverse events in clinical trials to date, even when administered at high dose levels. Current HAART therapies can have moderate to severe side-effects, including nausea, fever, kidney damage, diarrhea, bleeding and bone loss.

PRO 140 is an antibody rather than a drug.  It works by blocking the most prevalent HIV subtype from entering healthy cells, thus protecting them from infection. The FDA has awarded PRO 140 fast-track designation, and its approval as a combination therapy for HIV could come as soon as 2019, with the possibility of a monotherapy approval afterward as a label expansion.

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

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