NEW YORK, NY / ACCESSWIRE / June 13, 2016 / Rising Tide Equity Research, LLC announced today the release of its Initial Equity Report on CytoDyn (OTCQB: CYDY), a biotechnology company focused on the development of monoclonal antibodies for the treatment of human immunodeficiency virus (HIV) and Graph versus Host Disease (GvHD). The Company's lead clinical candidate, PRO 140, is currently in two Phase 3 trials evaluating its effectiveness as an adjunct therapy to current HIV treatment and as a monotherapy treatment for HIV.
The Company believes PRO 140 is uniquely positioned to address a growing HIV market as an alternative or addition to current therapies, which are failing primarily due to drug resistance. In seven clinical trials previously conducted, PRO 140 was generally well-tolerated, and no drug-related serious adverse events or dose-proportional adverse events were reported. The results of these studies established that PRO 140's antiviral activity was potent, rapid, prolonged, dose-dependent, and statistically significant following a single dose. PRO 140's mechanism of action (monoclonal antibody use in HIV) is a relatively new therapeutic approach and provides an effective method of suppressing the virus in treatment-experienced patients and as well as new frontline therapy.
Data from the PRO 140 monotherapy Phase 2b extension study will be discussed in an oral presentation entitled, "PRO 140 SC Monotherapy Provides Long-term, Full Virologic Suppression in HIV Patients," by Paul J. Maddon, MD, PhD, at the ASM Microbe 2016 Conference on Monday, June 20, 2016. Data from the Phase 2b extension study, found PRO 140 provided full virologic suppression, was well-tolerated, and enabled the avoidance of the potential toxicity of highly active anti-retroviral therapy (HAART), while preserving drug options for >1 year.
Current HIV Market
Gilead Sciences currently dominates the HIV treatment space, generating approximately $11 billion in revenue from their HAART regime. While effective, the HAART treatment is associated with significant side-effects, requires daily dosing, is susceptible to drug resistance, and not effective in all HIV patients. Current consensus within the medical community suggests that HIV treatment will soon be administered through intra-muscular or subcutaneous injections. ViiV Healthcare (a subsidiary of GlaxoSmithKline) and Janssen Pharmaceuticals are developing drugs that can be administered via intra-muscular injection and are in the early stages of clinical development. ViiV Healthcare is developing a drug cocktail using their integrase inhibitor cabotegravir and Janssen is utilizing a non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine). The intra-muscular approach requires clinic visits on a defined schedule in which the drug is injected into a large muscle group. TaiMed, a Taiwanese company, is developing a subcutaneous injection using ibalizumab, a human monoclonal antibody. Early proof of concept trials have shown positive results but further clinical development is pending at this time.
CtyoDyn's PRO 140 Competitive Advantage
In contrast to the HAART regime, PRO 140 is administered once weekly, via a self-administered subcutaneous injection. Clinical data has shown PRO 140 to have few toxicity or safety concerns and is equally efficacious to current treatment options. Patients in the ongoing Phase 2b monotherapy trial have experienced 20 months of full virologic suppression and the FDA recently approved a Compassionate Use Protocol for the continued administration of PRO 140 for patients completing CytoDyn's Adjunctive Therapy trial. CytoDyn's PRO 140 technology could revolutionize the treatment of HIV and other diseases such as GvHD. Key opinion leaders in the HIV field have indicated that injectable treatments are the future of HIV care and CytoDyn's PRO 140 is at the forefront of this space with two ongoing Phase 3 trials. If successful, the Company's technology would allow them to enter this multi-billion dollar market and initiate a paradigm shift in HIV treatment.
The complete Rising Tide Equity Report, including important disclosures, is available to download at no cost on the Rising Tide Equity Research website, www.risingtideequity.com/equity-research/.
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SOURCE: Rising Tide Equity Research