CytoDyn Inc (OTCMKTS:CYDY) Is Today's Biotech Focus

CytoDyn Inc (OTCMKTS:CYDY) is one of the most compelling biotechs on the market when it comes to HIV treatment. The company has even caught the attention of Charlie Sheen for its HIV treatment Pro 140. Further adding to the excitement is that last month the company submitted a Phase 3 protocol for a monotherapy trial, along with the Topline Report for its Phase 2b monotherapy trial to the FDA. The recent move higher in shares of CYDY could just be getting started as a result.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. CytoDyn 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.

The 300-patient Phase 3 monotherapy trial seeks to provide patients with a treatment option that would enable the use of a long-acting, infrequently administered monotherapy for the chronic suppression of CCR5-tropic HIV-1 infection. The study is designed to test the strategy of offering a carefully selected patient population on suppressive antiretroviral therapy the option of substituting PRO 140 for their oral drug regimen and remaining on PRO 140 for up to 48 weeks contingent on ongoing viral suppression.

CytoDyn’s Phase 2b treatment substitution study with PRO 140 was completed in January 2015. As of today, eleven patients have continued with this monotherapy Phase 2b in an extension trial. A majority of these patients have been participating in this trial for nearly 17 months, with two patients approaching 19 months of complete viral load suppression. On the recent corporate update, CEO Nader Pourhassan said:

"Our very impressive Phase 2b monotherapy trial has provided new opportunities for the future of PRO 140 and its outlook is getting better with each day. Patients in the extension on as we previously reported are passing one-and-a-half years of complete viral suppression and our making history. And their weakly results are continuing to amaze us. In the world of HIV, it is unheard of going without HAART, even for one-month, nonetheless for 18 months as our HIV patients have in the extension arm. These patients have only received a simple weekly subcutaneous injection of an antibody that is proven to have hardly any toxicity or side effect. If PRO 140 is ultimately approved as a monotherapy, then the eligible HIV patients could soon enjoy a life without all the toxicities that ranges from diarrhea, abdominal pain, nausea, to vomiting, rash, numbness, tingling, burning sensation, upset stomach, fatigue, chills, dizziness, headache, insomnia, fever and the list of drug toxicity goes on and on."

CytoDyn is on the verge of completely changing HIV treatment. This is truly revolutionary science. The company hopes to get to market within the next 24 months. 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.Currently trading with a market cap of $117 million, CYDY is on the verge of some very exciting developments. If the company can deliver with Pro 140, investors are looking at a multi-bagger as it will change the HIV treatment paradigm. We will be updating Insider Financial as soon as we know more. For continuing coverage on CYDY, sign up for our free newsletter today and get our next hot stock pick!Disclosure: We have no position in CYDY and have not been compensated for this article.