CytoDyn Inc (OTCMKTS:CYDY) Has Huge Potential

CytoDyn Inc (OTKTS:CYDY) is one small cap biotech that investors need to keep an eye on. It's one of the few companies making significant progress in the treatment of HIV/AIDS. Its most recent results showed that HIV was undetectable in the plasma of the patients undergoing CytoDyn's PRO 140 treatment. This is a major development and what has us very very intrigued.CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of Human Immunodeficiency Virus (HIV) infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has finished Phase 2 clinical trials with demonstrated antiviral activity in man and is currently in Phase 3. PRO 140 blocks the HIV co-receptor CCR5 on T-cells which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from six Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. A recent Phase 2b clinical trial demonstrated that PRO 140 can prevent viral escape in patients during several weeks of interruption from conventional drug therapy. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV and to pursue non-HIV indications where CCR5 and its ligand CCL5 may be involved.PRO 140 belongs to a new class of HIV/AIDS therapeutics -- viral-entry inhibitors -- that are intended to protect healthy cells from viral infection. PRO 140 is a fully humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T-cells. PRO 140 blocks the predominant HIV (R5) subtype entry into T-cells by masking this required co-receptor, CCR5. Importantly, PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. PRO 140 does not have agonist activity towards CCR5, but does have antagonist activity to CCL5, which is a central mediator in inflammatory diseases. PRO 140 has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. PRO 140 has been designated a “fast track” product candidate by the FDA. The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use.CYDY just announced that 11 patients have achieved full virologic suppression in the Phase 2b extension study evaluating long-term suppression of HIV replication by PRO 140 monotherapy. These patients self-administered PRO 140 weekly for 14 to 17 months. Using a very sensitive, single-copy HIV-1 RNA assay, seven of 10 patients had less than one viral copy per milliliter in their blood in the most recent month of treatment. The median of the lowest HIV RNA levels detected in these 10 patients was 0.4 viral copies per milliliter of blood.

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CytoDyn’s PRO 140 Phase 2b study was completed in January 2015. Following the initial 13-week treatment period, patients with viral load suppression were trained to self-administer PRO 140 and offered continuation of monotherapy in an ongoing extension study with biweekly monitoring up to 60 weeks and monthly monitoring beyond 60 weeks. Patients enrolled in this study are infected with strains of HIV that utilize exclusively the CCR5 co-receptor. The PRO 140 monoclonal antibody targets CCR5 with high affinity and blocks HIV infection. These patients substituted their daily Anti-Retroviral Therapy (ART) regimen with weekly subcutaneous injections of PRO 140 monotherapy throughout the trial and extension study. PRO 140 was well tolerated with no drug-related major adverse events or treatment discontinuation reported.What we find most interesting is what CytoDyn CEO Dr. Nader Pourhassan said.

“We believe this data clearly supports our planned label expansion study with PRO 140 as a monotherapy for HIV patients. Success with PRO 140 monotherapy in the label expansion Phase 3 study means that, if approved, PRO 140 could change the HIV-treatment paradigm and provide a potential solution to what has been a nagging problem in the HIV patient population, which is compliance with taking multiple pills daily for life. PRO 140’s easy, subcutaneous delivery is the first such alternative to existing ART therapy and the toxicity issue associated with such treatments. We are very pleased with our results thus far and future possibilities for certain patients infected with HIV.”

That's right. CytoDyn is on the verge of completely changing HIV treatment. This is truly revolutionary science. Where CYDY stands right now is that the company plans to file a second Phase 3 protocol for PRO 140 monotherapy with the FDA. CytoDyn is currently conducting a pivotal Phase 3 trial for PRO 140 as an adjunct therapy with expected commercialization in 2017. This is critical as only about 25% of HIV patients in the U.S. have a completely suppressed viral load. A large contributor to this problem is due to patients’ inability to adhere to a highly structured schedule to take their medications on a specific timetable every day of their lives (Anti-Retroviral Therapy or ART). PRO 140 is administered as a simple, weekly subcutaneous injection and could be the solution to this very serious adherence problem.Just this week, CytoDyn filed a request for Breakthrough Therapy Designation with the FDA for PRO 140 as a Treatment for HIV-1 Infection in Treatment-Experienced Patients with Virologic Failure. So far, CytoDyn's three clinical studies demonstrated the proof of concept that PRO 140 monotherapy can reduce the viral load in HIV-1 infected, treatment-experienced patients. Once the viral load is undetectable, weekly administration of PRO 140 can help maintain the lower viral load in about 50% of patients over an extended period of time (currently shown to be over one year). Based on these preliminary results, the Company believes this treatment option addresses the unmet medical need for therapy options for HIV-1 infected patients with uncontrolled viral load, despite conventional ART. The patients who do not benefit from continuing ART could potentially benefit from PRO 140 therapy.

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Currently trading at around a $108 million market cap, CYDY could be a billion-dollar company if the company gets FDA approval and goes into commercialization. The company is expecting this to occur next year. So far, the company has been delivering and it's proving that its treatment works. Now it just needs to get the FDA on its side. If this occurs, shorts like Tim Sykes are going to be running to cover as this stock takes off. We will be updating Insider Financial with the latest developments on CYDY. Sign up today!

Disclosure: We have no position in CYDY either long or short. We have not been compensated for this article.