CytoDyn Inc (OTCMKTS:CYDY) just announced that it has filed a Phase 2 protocol for a basket trial with the U.S. Food and Drug Administration (FDA) under its cancer IND. Note, this is a stock we flagged as overly opportunistic in its communications after it claimed it had the key medicine to stop the coronavirus outbreak. Since that piece, shares have fallen sharply.
According to the release, “The Company can immediately initiate enrollment in this Phase 2 clinical trial for the treatment of approximately 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, among other indications. The Company expects to receive preliminary results on each patient within 3 to 4 weeks after the initial treatment with leronlimab. The Company will continue to enroll patients in its metastatic breast cancer trials.”
CytoDyn Inc (OTCMKTS:CYDY) promulgates itself as a late-stage biotechnology company that focuses on the clinical development and commercialization of humanized monoclonal antibodies to treat human immunodeficiency virus (HIV) infection.
Its lead product is PRO 140, a therapeutic anti-viral agent, which is in Phase IIb extension study for HIV as monotherapy, rollover study for HIV as a combination therapy, Phase IIb/III investigative trial for HIV, Phase Ib/II trial for triple-negative breast cancer, and Phase II trial for graft-versus-host disease.
CytoDyn Inc. has strategic agreement with Samsung BioLogics Co. Ltd. for the clinical and commercial manufacturing of leronlimab. The company was formerly known as RexRay Corporation. CytoDyn Inc. was incorporated in 2002 and is based in Vancouver, Washington.
According to company materials, “CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab (PRO 140) as a once-weekly monotherapy for HIV-infected patients and, plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab (PRO 140) can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.”
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As noted above, CYDY just announced that it has filed a Phase 2 protocol for a basket trial with the U.S. Food and Drug Administration (FDA) under its cancer IND.
Traders will note 22% during the past month in terms of shareholder gains in the stock. Furthermore, the listing has seen interest climb, with an increase in recent trading volume of 270% beyond what we have been seeing over the larger time frame. However, the past two days have featured a meltdown in the name, giving up over a third of its value.
Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn commented, “The results so far in breast cancer patients have remarkably demonstrated the shrinking of primary tumors, the shrinking or elimination of metastatic lesions, and the reduction of CTCs to zero which has remained stable over weeks. In other studies, we have seen CTC levels in this cancer >5 and some as high as 20 per 4 mL of blood. Further, these data help define the relationship between CCR5 on immune cell infiltrates and response as we analyze these responding patients.”
Earning a current market cap value of $585M, CYDY has a reserve ($1.2M) of cash on the books, which must be weighed relative to about $29.7M in total current liabilities. One should also note that debt has been growing over recent quarters. The company is pre-revenue at this point. We will update the story again as soon as developments transpire. Sign-up for continuing coverage on shares of $CYDY stock, as well as other hot stock picks, get our free newsletter today and get our next breakout pick!
Disclosure: we hold no position in $CYDY, either long or short, and we have not been compensated for this article.