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CytoDyn Inc (OTCMKTS:CYDY) Could Get Boost From Charlie Sheen

CytoDyn Inc (OTCMKTS:CYDY) Could Get Boost From Charlie Sheen
Written by
Alex Carlson
Published on
February 13, 2016
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CytoDyn Inc (OTCMKTS:CYDY) is hoping to get a boost from Charlie Sheen going on its HIV treatment Pro 140. The celebrity actor appeared on the Dr. Oz show with CytoDyn CEO Nader Pourhassan to discuss enrolling in CytoDyn's clinical trial. If he joins the trial, the ramifications for this tiny biotech could be monumental. His enrollment would create worldwide media attention for CytoDyn in its fight against HIV. There is certainly hope for Charlie Sheen by joining the trial. CytoDyn's 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 in the world of HIV treatment and why we are so interested in shares of CYDY.

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.Charlie Sheen learned first hand the importance of proper HIV treatment. His viral load skyrocketed after he went off traditional HIV meds and pursued an alternative goat-milk based treatment in Mexico. Obviously, Sheen would rather find a better solution than living off of pills from Gilead Sciences Inc (NASDAQ:GILD) with its Viread and Atripla drugs.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.CYDY is currently trading at a market cap of $134 million. To fund its trials and R&D, the company has issued 33,338,884 shares of common stock and warrants to purchase 16,669,391 shares of common stock, for aggregate gross proceeds of approximately $25.0 million since October. This should be enough to get CYDY over the hump. For continuing coverage on CYDY and our other hot stock picks, sign up to Insider Financial today and get our free penny stock newsletter!Disclosure: We have no position in CYDY and have not been compensated for this article.

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