- FinancialBuzz.com News Commentary
NEW YORK, April 17, 2020 /PRNewswire/ -- The pandemic has drastically changed the world's social and economic landscape since the virus was first identified in January. Countries have shut down schools and businesses, restricted travel, canceled entertainment and sporting events, and are encouraging the public to stay at home as much as possible. As of Thursday, nearly 140,000 people have died worldwide of COVID-19, according to data from Johns Hopkins University. The United States has the highest confirmed death toll, with more than 31,000 fatalities as of Thursday morning. As a result, several biotechs, as well as medical device companies, have made announcements that vaccines are being developed or testing kits are in production. As for general testing, labs and healthcare facilities are facing supply shortages, a lack of instrument access, as well as increased staffing needs. In response, the FDA has opened its emergency use authorization (EUA) process to high-complexity CLIA labs on Feb. 28th, creating a new pathway for regulated assay development. Codebase Ventures Inc. (OTC: BKLLF) (CSE: CODE), iBio, Inc. (NYSE: IBIO), Co-Diagnostics, Inc. (NASDAQ: CODX), OPKO Health, Inc. (NASDAQ: OPK), Aytu BioScience, Inc. (NASDAQ: AYTU)
As testing finally becomes more widespread, the next crucial step is to trace the contacts of those who have tested positive. Therefore, San Francisco is launching an innovative contact tracing program to strengthen coronavirus response. "Today, we are laser focused on the health emergency in our city," said Dr. Grant Colfax. "We are doing everything we can to reduce the spread of the virus in our community, protect vulnerable populations, health care workers and first responders. But even as we respond to outbreaks now, we are looking ahead. We need to build a fast-moving, comprehensive system to track cases and support people to prevent further spread as much as possible as we ultimately move out of shelter in place into a new phase of fighting the pandemic."
Codebase Ventures Inc. (OTCQB: BKLLF) (CSE: CODE) is also listed on the Canadian Securities Exchange under the ticker (CSE: CODE). The company announced breaking news yesterday morning that it "is excited to announce that it has finalized a definitive agreement as of April 15th, 2020, securing the rights to an innovative drug delivery system for hydroxychloroquine.
'Codebase has finalized an exclusive agreement to launch a development transdermal patch program for hydroxychloroquine,' said Mr. George Tsafalas, Codebase President & CEO. 'Hydroxychloroquine in its current decades-old oral tablet form is subject to inconsistent dosing and side effects including nausea, vomiting, blurred vision, headache and overall toxicity.'
- Hydroxychloroquine has been heavily publicized as a promising drug treatment available today for Covid-19
- CODE has agreed to acquire a 49% interest in a private company that has secured the rights to the recently applied provisional patent application for a transdermal delivery system for hydroxychloroquine (HCQ)
- On March 28th, the FDA approved the emergency use of HCQ for Covid-19 patients and health care workers in an unprecedented move
- This transformative delivery system will initially target Covid-19 through the FDA 505(b)(2) accelerated pathway provisions, and in the long term for the drug's FDA approved applications for malaria, lupus and rheumatoid arthritis – providing an innovation for those long-term patients who have depended on HCQ for decades and had to accept the side effects related to oral delivery.
Codebase has entered into an arms-length agreement to acquire a 49% interest in a private company, Glanis Pharmaceuticals Inc, that has recently filed for a US provisional patent for the transdermal delivery of hydroxychloroquine. The Company will issue up to 35 million common shares to the shareholders of this private company, as well as another 25 million shares pursuant to a lab services agreement with a New York based laboratory, Reformulation Research Laboratories Inc. (RRL), that developed the patent application and the underlying technology. These shares will be issued at a deemed price of $0.05 per share. The agreement is subject to closing conditions usually found in transactions of this kind.
While hydroxychloroquine is the subject of various early studies of its effectiveness against the Covid-19, its present on-label uses as a treatment against malaria, lupus and rheumatoid arthritis provides a ready market for this proposed new delivery system. This new delivery method should eliminate or reduce a number of the common side effects of this treatment, including nausea, vomiting, loss of appetite, diarrhea, dizziness, or headache by providing a controlled constant delivery.
Transdermal delivery can provide a drug plasma concentration at predetermined rate for a predetermined period of time, potentially drastically reducing side effects from decades-old oral tablets. Safe, consistent doses will make the drug much more effective at reduced dosages required because the GI system is avoided with transdermal delivery.
RRL has a combined 75 years of expertise in transdermal delivery systems that provide the capacity, equipment and capabilities to advance the development program for a hydroxychloroquine molecule for transdermal delivery from research, testing, regulatory approvals through to launch of the hydroxychloroquine transdermal delivery system.
The current phase of development includes literature search and pre-formulation studies.
The Company's scientific expert has read and approved the scientific disclosures contained in the press release.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 at this time."
For our latest "Buzz on the Street" Show featuring Codebase Ventures Inc. recent corporate news, please head over to: https://www.youtube.com/watch?v=KjW9JynKBio
iBio, Inc. (NYSE: IBIO) announced earlier this month the signing of two Master Services Agreements and a Memorandum of Understanding with the Infectious Disease Research Institute ("IDRI") in support of iBio's SARS-CoV-2 Virus-Like Particle ("VLP") vaccine development. Under the MSAs, IDRI will support pre-clinical development and provide clinical trial oversight, while iBio will provide process development and manufacturing services to IDRI, as needed. Additionally, the MoU calls for iBio and IDRI to establish a separate, additional agreement within the next 60 days if the Company opts to include one of IDRI's novel adjuvants in the COVID-19 vaccine development program ("IBIO-200"). The MSAs and the MoU integrate IDRI into iBio's collaboration with the Texas A&M University System to create a strong partnership that brings deep experience and advanced technologies and capabilities to the task of moving IBIO-200 into the clinic.
Co-Diagnostics, Inc. (NASDAQ: CODX) that OralDNA® Labs, a CLIA-certified laboratory, has recently validated a COVID-19 PCR test based on the Company's patented CoPrimer™ technology for use with saline oral rinse samples, and has notified the FDA of their intent to use the validated test in their CAP accredited high-complexity laboratory. Dwight Egan, Co-Diagnostics CEO, remarked, "This validation on the OraRisk® line of salivary diagnostics showcases the versatility and flexibility of our CoPrimer platform and COVID-19 test. Saliva specimens are easily collected with a simple swish and gargle, as opposed to more invasive collection methods such as nasal swabs. We are pleased that our technology is being deployed in so many areas in the United States and countries across the world, providing the type of quality, high-throughput diagnostic solutions that many experts agree is the most important step to curbing the spread of COVID-19 and saving lives."
OPKO Health, Inc. (NASDAQ: OPK) announced that it will continue to prioritize COVID-19 testing for hospital inpatients and critically ill patients around the country. "Our goal is to maintain the current 24-hour turnaround time for these patients," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Nothing is more important than getting a timely result back to the medical personnel on the front lines making treatment decisions on a minute-to-minute basis." "Multiple types of hospitals, for-profit, not-for-profit, large health systems, individual hospitals, academic medical centers, and community hospitals have all reached out to get their results in a timely fashion. We have now tested almost 200,000 patients and will continue to grow our capacity from 20,000 tests/day to 35,000 tests/day within the next week. While prioritizing hospital patients, at the same time we will continue to strive to keep our current turnaround time for non-hospital patients at 2-3 days from the time we receive the specimen," said Dr. Cohen.
Aytu BioScience, Inc. (NASDAQ: AYTU) announced yesterday that results from an independent clinical study using the Company's licensed Coronavirus Disease 2019 ("COVID-19") IgG/IgM Rapid Test were published in the journal Infection Ecology & Epidemiology, further validating the accuracy, specificity and performance of the antibody rapid test. In this recently published clinical study which included 29 COVID-19 positive cases confirmed by PCR and 124 healthy donors, the rapid test showed an overall specificity of 100% and 99.2% for IgM and IgG, respectively. The authors note, "The high negative predictive value indicates that the rapid test will be useful for detecting past infections and possible immunity, which may be crucial for restoring social functions after lockdown."
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