| CytoDyn (OTCQB: CYDY) Soars on Early Coronavirus Treatment Success |
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CytoDyn (OTCQB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, has treated 10 patients under its emergency IND, approved by the FDA, for the treatment of the coronavirus. Test results from the first four patients suggests immunological benefit within three days following treatment and lower level of cytokine storm, especially IL-6 and TNF-α, which were reduced significantly.
Why It Matters: The treatment with leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). Leronlimab is believed to provide therapeutic benefit by enhancing the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in these patients.
Key Quote: “These preliminary results give hope that leronlimab may help hospitalized patients with COVID-19 recover from the pulmonary inflammation that drives mortality and the need for ventilators. A leading medical center in the heart of the New York City epidemic was instrumental in giving the preliminary data.” – Jacob Lalezari, M.D., Interim Chief Medical Officer
The Backstory: 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 antiretroviral 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 the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab 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 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.
Disclosure
CytoDyn (CYDY) is a client of RedChip Companies, Inc. CYDY agreed to pay RedChip Companies, Inc., a $20,000 quarterly cash fee, beginning in February 2020, for RedChip investor awareness services.
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| Can-Fite BioPharma (NYSE American: CANF) Implements Interim Analysis for Phase III Psoriasis Trial with Data Expected Q4 2020 |
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Can-Fite BioPharma (NYSE American: CANF), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, is implementing an interim analysis of the Phase III Comfort™ trial designed to evaluate the Company’s drug candidate, Piclidenoson, in the treatment of moderate-to-severe plaque psoriasis. Following the independent data monitoring committee’s evaluation of the data, Can-Fite expects to announce interim results in the fourth quarter of 2020.
Why It Matters: The Comfort™ Phase III psoriasis study is designed to establish Piclidenoson’s superiority compared to placebo and non-inferiority compared to Apremilast (Otezla®) in patients with moderate to severe plaque psoriasis. The randomized, double blind study is being conducted in Europe, Israel, and Canada. The study’s primary endpoint is the proportion of subjects who achieve a PASI score response of ≥75% (PASI 75) vs. placebo at week 16. The secondary endpoints include non-inferiority to Otezla® on weeks 16 and 32. A Drug Safety Update Report filed in February 2020 with regulatory agencies reported that Piclidenoson, which has been dosed in over 1,400 patients, is well tolerated and has no emerging safety concerns.
Key Quote: “By implementing this interim analysis, we gain earlier access to data on Piclidenoson’s efficacy in the treatment of psoriasis, as well as more safety data on Piclidenoson, which is also currently being evaluated as a treatment for rheumatoid arthritis, and being considered as a potential treatment for COVID-19.” – Dr. Pnina Fishman, CEO
Backstory: Can Fite’s drug Piclidenoson has been out-licensed for the indication of psoriasis in Canada, South Korea, Spain, Austria, Switzerland, Hong Kong, Macau, Taiwan, and China. According to iHealthcareAnalyst, the psoriasis therapeutic market is estimated to reach $11.3 billion by 2025.
Disclosure
Can-Fite Biopharma (CANF) is a client of RedChip Companies, Inc. CANF agreed to pay RedChip Companies, Inc. a cash fee of $5,000 monthly, beginning in August 2019, and 16,500 shares of CANF Rule 144 stock for 6 months of RedChip investor awareness services and consulting services.
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| Digital Ally (NASDAQ: DGLY) Receives Multi-Year Upgrade Order for its EVO-HD In-Car System for Law Enforcement |
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Digital Ally (NASDAQ: DGLY) which develops, manufactures and markets advanced video recording products for law enforcement, emergency management, fleet safety and security, received a multi-year upgrade order from Box Elder Sheriff’s Department (Brigham City, Utah) for 18 of its highly advanced EVO-HD in-car camera systems paired with 18 FirstVu HD body-worn cameras, built-in patented VuLink® auto-activation technology and migration to the VuVault® cloud storage solution hosted by Amazon Web Services.
Why It Matters: The EVO-HD is a highly advanced, innovative in-car camera system offered by Digital Ally. With built-in patented VuLink® auto-activation technology and multiple HD cameras, EVO-HD is the most advanced system for law enforcement. When outfitted with the FirstVu HD body-worn camera the EVO-HD can automatically start a recording of the body camera and simultaneously record both camera feeds. All video evidence is hosted on the highly secure GovCloud platform powered by Amazon Web Service.
Key Quote: “Our EVO-HD paired with the FirstVu HD body-worn camera continues to prove that they are an essential tool to everyday law enforcement officers. Through these tough times Digital Ally remains committed to serving all first responders and providing the necessary equipment and support needed daily.” – Stan Ross, CEO
The Backstory: Headquartered in Lenexa, KS, Digital Ally specializes in the design and manufacturing of the highest quality video recording equipment and video analytic software. Digital Ally pushes the boundaries of technology in industries such as law enforcement, emergency management, fleet safety and security. Digital Ally’s complete product solutions include vehicle and body cameras, flexible software storage, and automatic recording technology. These products work seamlessly together and are simple to install and operate. Digital Ally products are sold by domestic direct sales representatives and international distributors worldwide.
Disclosure
Digital Ally, Inc. (DGLY) is a client of RedChip Companies, Inc. DGLY agreed to pay RedChip Companies, Inc., a $7,500 monthly cash fee, beginning in September 2017, for RedChip investor awareness services.
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| Nemaura (NASDAQ: NMRD) to Launch New Digital Brand proBEAT™ in the US Targeting 100+ Million Potential Users |
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Nemaura Medical (NASDAQ: NMRD), a medical technology company focused on developing micro-systems-based wearable diagnostic devices and digital solutions for the medical and consumer markets, announced it is planning to launch a digital healthcare subscription service in the USA under the brand name proBEAT™.
Why It Matters: proBEAT™ is expected to be available without the need for a prescription and appeal to a broad range of adults encompassing pre-diabetic and Type 2 diabetics, numbering 88 million, and 26 million people respectively1, as well as those seeking to lose weight and/or seeking a healthier lifestyle. proBEAT™ is expected to help users improve their knowledge of how a range of lifestyle, dietary and health and wellbeing factors impact their sugar levels by acting like a black box flight recorder. Big data about the multitude of factors that affect glucose levels will be gathered from all users and employed in developing and subsequently ‘fine-tuning’ predictive algorithms and artificial intelligence-based feedback and prompts. These will then be able to both educate and provide motivational tools to the user to encourage them to lead a healthier lifestyle.
The Backstory: The first phase of the commercial launch of sugarBEAT® began in the UK after the Company received CE Mark approval in 2019. In this initial phase, devices were supplied to a limited cohort of users while the Company focused on scaling up its manufacturing operations. The UK licensee of sugarBEAT®, DB Ethitronix, is currently in the process finalizing the launch of online sales of sugarBEAT®. The Company is currently planning a user study comparing sugarBEAT® directly against a highly successful major incumbent CGM sensor with the goal of positioning sugarBEAT® as a non-invasive, daily/flexible, cost-effective alternative to traditional, expensive and invasive CGM.
Disclosure
Nemaura Medical (NMRD) is a client of RedChip Companies. NMRD agreed to pay RedChip a monthly cash fee of $5,000 for six months of investor awareness services. RedChip also received 20,000 shares of Rule 144 stock for services performed between December 2018 and May 2019.
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| Quote of the Week |
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"The single most important way we attempt to manage risk, in any environment, is by seeking to buy stocks very cheaply—we never want to pay too much."
- Bill Hench, Portfolio Manager, Royce Opportunity Funds |
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