An Update On CytoDyn Inc (OTCMKTS:CYDY)

CytoDyn Inc (OTCMKTS:CYDY) is a name that we've been covering all year here at Insider Financial. While the stock has a history of violent moves higher, shares have consolidated around the $1 mark for over two months, but have now started creeping up. Could some major developments regarding PRO 140 just be around the corner?First up, a little background on the company. CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection. The company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has completed 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 seven 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 months 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 latest news regarding PRO 140 is that the first of 11 HIV-1 patients receiving PRO 140 as a monotherapy in a Phase 2b extension study has reached two years of complete virologic suppression. Four additional patients are expected to reach the two-year benchmark in the next three weeks and five more patients are expected to reach this benchmark in approximately two months.Patients in the Phase 2b extension study showed full HIV viral load suppression during a 12-week Phase 2b study in which they receive weekly PRO 140 subcutaneous injections (one 350 mg dose) in place of their HAART regimens. Forty patients were enrolled in the Phase 2b trial, of which 35 were evaluable and five were excluded for tropism screening failures or protocol violations. Twenty patients completed the 12-week Phase 2b study with HIV viral load suppression and were eligible for the extension arm. Fifteen patients of the 20 were granted entry into the extension arm. Four of the fifteen patients that entered the extension arm were disqualified due to lack of follow-up (relocation) or disqualification unrelated to PRO 140 and one was a treatment failure, leaving 10 evaluable patients, which are now at or close to the two-year benchmark of complete HIV viral load suppression while on PRO 140 as a monotherapy.

Of the 11 patients currently receiving weekly PRO 140 injections in the Phase 2b extension study, one patient recently entered the study, having shown complete HIV viral load suppression following an initial 12-week treatment period. This patient was one of three patients who were allowed to qualify for the Phase 2b extension study within the past two to four months by the trial’s Data Safety Monitoring Board due to the disqualification of three patients in the original Phase 2b study for tropism screening errors.

Patients qualifying for the Phase 2b monotherapy study were evaluated for infection with strains of HIV-1 that utilize the CCR5 co-receptor. The PRO 140 monoclonal antibody targets CCR5 with high affinity and potently blocks HIV-1 cell entry. Complete virologic suppression is defined as plasma HIV-1 RNA less than 40 copies/mL, which is the lower limit of detection in the commercial assay. Blood drawn after one year of monotherapy from nine patients in the Phase 2b extension study were tested with a single copy HIV-1 research test. In six of the nine patients whose viral load was checked with a single copy assay, the viral load was documented to be less than one HIV-1 RNA copy/mL blood and two patients had less than 4 copies/mL.

Last month, CytoDyn enrolled its first patient under a recently modified protocol in the Company’s Phase 3 combination study with PRO 14O (humanized monoclonal antibody to CCR5). The modified protocol has been cleared by the U.S. Food and Drug Administration (FDA) and features a 50% reduction in enrollment to 150 subjects and relaxed enrollment criteria allowing HIV-infected subjects to enter the study before confirmation of the R5 strain. PRO 140 has proven effective in managing the viral load of people infected with the R5 strain of HIV, which accounts for approximately 67% of infected Americans and up to 85% of those newly diagnosed.

The multicenter, randomized Phase 3 combination study is evaluating the efficacy and safety of PRO 140 combined with standard of care antiretroviral therapy (ART) in treatment-experienced HIV-infected patients who are failing their ART therapy. The study is divided into two parts, with part one as a double-blind treatment period in which study subjects are randomized and treated with either PRO 140 or placebo weekly subcutaneous injections in combination with their failing ART regimen for up to one week. During this week, each subject is evaluated for HIV-1 genotypic drug resistance and a new optimized ART regimen is developed. In the second part of the study, subjects continue treatment with either PRO 140 or placebo in combination with the optimized background therapy (OBT) for up to an additional three weeks, when the HIV-1 co-receptor tropism assay results (i.e., determination of R5 strain) are available. At this time, subjects will move to a 24-week, open-label period. Only subjects with R5 virus will be treated with PRO 140 and OBT, whereas subjects with X4 or dual/mixed-tropic virus will receive OBT alone during the 24-week open-label treatment period.

Currently trading with a market cap of $137 million, CYDY has $9.6 million in cash to get it through the next few quarters. If PRO 140 delivers like we expect it to, CYDY will be off and running. CytoDyn is one of the very few companies trading on the OTC Markets that has the potential to become a multi-bagger for investors. We will be updating our subscribers as soon as we know more. For the latest updates on CYDY, sign up below!

Disclosure: We have no position in CYDY and have not been compensated for this article.