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FDA accepted MediciNova's IND for MN-166 (ibudilast) for prevention of Acute Respiratory Distress Syndrome (ARDS) in COVID-19 and informs the company that it may proceed with the proposed clinical investigation of ibudilast.
https://www.google.com/amp/s/seekingalpha.com/amp/news/3587628-medicinova-on-go-study-of-mnminus-166-in-covidminus-19
https://seekingalpha.com/news/3587628-medicinova-on-go-study-of-mnminus-166-in-covidminus-19
To see whether mice develop an illness similar to the one in people, the researchers infected mice with the modified adenovirus, and then five days later gave them the COVID-19 virus through the nose. The virus quickly spread along the respiratory tract and especially to the lungs, where it replicated to high numbers and caused pneumonia with marked inflammation, much as it does in people. The researchers also found lower levels of virus in the heart, spleen and brain—all organs that can be targets of the virus in people. The mice lost 10% to 25% of their body weight during their illnesses but ultimately recovered.
"The mice develop a similar lung disease to what we see in humans," said Diamond, who is also a professor of molecular microbiology, and of pathology and immunology. "They get quite sick for a while but eventually recover, like the vast majority of people who get COVID-19. You can use this technique with almost any strain of laboratory mouse to make them susceptible to SARS-CoV-2 and then do whatever kind of study you want: test vaccines or drugs, study the immune response, and many other things related to how the virus causes disease."
https://medicalxpress.com/news/2020-06-covid-mouse-drugs-vaccines.html
A mouse model study was conducted to assess systemic IgG and mucosal IgA antibody production against S1 Ag after intranasal vaccination with MediciNova’s BC-PIV SARS-CoV-2 vaccine prototype. We confirmed a high IgA antibody titer against S1 Ag in the nasal lavage fluid from mice given intranasal BC-PIV SARS-CoV-2 vaccine. We also confirmed that a high IgG antibody titer against S1 Ag was induced in mice serum.
Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc., commented, "We are very encouraged that our intranasal BC-PIV SARS-CoV-2 vaccine induced high titers of systemic serum IgG and mucosal IgA neutralizing antibodies in a mouse model study. These successful results support the scientific and technical rationale of our intranasal vaccine in addition to similar success with BioComo’s BC-PIV RSV vaccine prototype. We look forward to reporting additional progress on our intranasal COVID-19 vaccine in the near future.”
https://finance.yahoo.com/news/medicinova-announces-intranasal-covid-19-103000673.html
Medicinova’s resources are jointly helping BioComo to produce a COVID-19 vaccine - - President Masayuki Fukumura, Mie prefecture, Japan; http://www.biocomo.jp/).
Medicinova said: President and Chief Executive Officer of MediciNova, Inc., commented, "Given the current global pandemic of COVID-19, we appreciate this very important opportunity to jointly develop a vaccine against SARS-CoV-2 with BC-PIV in collaboration with BioComo and Mie University. Previously, BioComo has been successful in developing vaccines against Ebola virus and RS virus with their BC-PIV technology, which made us confident that their technology will be successful for SARS-CoV-2 vaccines.”
BioComo said: Masayuki Fukumura, President of BioComo, commented, “We are very pleased to proceed with the co-development of a SARS-CoV-2 vaccine with MediciNova which has a proven track record of international clinical development for unmet medical needs.”
MediciNova has been granted exclusive worldwide development rights to use BC-PIV for SARS-CoV-2 vaccine development from BioComo and Mie University.
Spread company news on other boards.
Clinical pipeline development progress image & link:
https://medicinova.com/clinical-development/development-pipeline/
MediciNova said administering MN-166 with cancer medication oxaliplatin resulted in improvement or stabilization of oxaliplatin-induced neurotoxicity in the majority of participants treated with oxaliplatin.
Half of the study's participants "reported improved symptoms in the acute period and showed improved neurological parameters on clinical assessment with ibudilast treatment," said MediciNova CEO and President Yuichi Iwaki in a statement.
BC-PIV, an innovative non-transmissible viral vector co-developed by BioComo and Mie University, is derived from the recombinant human parainfluenza virus type 2 (hPIV2). BC-PIV is highly efficient to transfer multiple foreign proteins to recipients with a strong safety profile, without secondary protein infections. BC-PIV displays the gene and foreign protein inside and outside of the viral membrane. BC-PIV can carry large membrane proteins of viruses and signal transduction receptors/ligand proteins on the viral surface. BC-PIV can carry proteins that require a proper three-dimensional structure or multimeric structure while maintaining the structure. BC-PIV elicits good immunogenicity against antigen proteins without adjuvants. The SARS-CoV-2 vaccine prototype has been developed to include the specific SARS-CoV-2 antigen protein in order to express maximum antigenicity. To date, BioComo has succeeded in producing a recombinant Ebola virus vaccine (https://www.nature.com/articles/s41598-019-49579-y) and a Respiratory Syncytial virus prefusion F vaccine (unpublished data) using this BC-PIV platform technology.
Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc., commented, "Given the current global pandemic of COVID-19, we appreciate this very important opportunity to jointly develop a vaccine against SARS-CoV-2 with BC-PIV in collaboration with BioComo and Mie University.
Previously, BioComo has also successfully developed vaccines against Ebola and RS viruses with BC-PIV technology and assured a successful vaccine for SARS-CoV-2.
We feel a great sense of mission to initiate this SARS-CoV-2 vaccine project in addition to our MN-166 project targeting ARDS, which is a very serious and potentially fatal disease that can be caused by COVID-19."
Masayuki Fukumura, President of BioComo, commented, “We are very pleased to proceed with the co-development of a SARS-CoV-2 vaccine with MediciNova which has a proven track record of international clinical development for unmet medical needs. We initiated the development of a novel BC-PIV SARS-CoV-2 vaccine with Dr. Tetsuya Nosaka in March of this year (http://www.biocomo.jp/20200319.pdf).
Multiple stabilized Spike protein mutants of SARS-CoV-2 were devised and the respective genes and proteins were loaded onto BC-PIV.
We already completed core characterization studies with mice models.
BC-PIV is characterized by its ability to load a large antigenic protein retaining the three-dimensional structure of the vector envelope and its high affinity for the nasal mucosa and upper respiratory tract mucosa and induces local mucosal immunity.
BC-PIV can be an intra-nasal vaccine in addition to an intra-muscular injection because of its high affinity to nasal and upper respiratory tract mucosa, which is the same route of the natural infection of SARS-CoV-2. An intra-nasal vaccine is expected to induce local mucosal immunity.
GMP manufacturing has been one of the barriers for us until now, but through our joint development with MediciNova, we will proceed with further non-clinical and clinical trial development as quickly as possible globally and not only in Japan.
We are thrilled with the challenge to develop a vaccine that has potential clinical application to limit the spread of SARS-CoV-2.”
Tetsuya Nosaka, Professor at Mie University Graduate School of Medicine, commented, “I am very excited about the outcome of the long-standing development of the vector and genetically modified vaccines with BioComo that can be applied to prevent COVID-19, a major global health threat. We believe BC-PIV is effective, safe, convenient, and cost efficient as a vaccine vector, and have been seeking an opportunity for the clinical application for long time.
However, the academic research environment has been less encouraging lately. Therefore, it is a great encouragement for us as member of the academic community to achieve this international joint development with MediciNova, which has an abundant track record of manufacturing and clinical development.
We are confident that the BC-PIV SARS-CoV-2 vaccine will be successful and hope that this vaccine will be available in a clinical setting as soon as possible and will be the “gospel” for the people in the world.”
THIS LOOKS REALLY STRONG.
David Jenkins, Catheter Precision's Chairman stated, "We are extremely impressed with Hancock Jaffe's early clinical successes and believe that its products have enormous potential. Our goal is to use the public company platform to focus on cardiovascular devices as our core competency, with the possibility of expanding into other areas as we grow the company."
https://ir.hancockjaffe.com/press-releases/detail/66/hancock-jaffe-announces-intention-to-merge-with-catheter
Should be any day. There is a 30-60 day period of exclusivity to finalize formalities - - “The parties have entered into a period of exclusivity in order to negotiate the proposed transaction in good faith.”
https://ir.hancockjaffe.com/press-releases/detail/66/hancock-jaffe-announces-intention-to-merge-with-catheter
“David Jenkins, Catheter Precision's Chairman stated, "We are extremely impressed with Hancock Jaffe's early clinical successes and believe that its products have enormous potential. Our goal is to use the public company platform to focus on cardiovascular devices as our core competency, with the possibility of expanding into other areas as we grow the company."
HJLI Receives Permission to Proceed with First-in-Human CoreoGraft Study
https://www.biospace.com/article/releases/hancock-jaffe-laboratories-company-update/
-“two CoreoGraft surgeries per week, once patients are enrolled in the study. Following patient enrollment, the CoreoGraft surgeries will likely be completed over a four-week period. CoreoGrafts will be implanted in patients needing coronary artery bypass graft ("CABG") surgeries.”
Hancock Jaffe Enrolls Initial Patients for First-in-Human CoreoGraft Study
Market makers aren’t manipulating the prices. The prices you are seeing are set from traders and active traders. Market makers match prices, now done by computers, and market makers also set the first quote. Don’t believe the bs from posters.
Merger will be milestone for first in class device. Mr. Jenkins has extensive experience in M&A and device product, development. GET READY$$$$$$
Catheter Precision is led by Chairman David Jenkins and CEO Steve Adler. Mr. Jenkins is a seasoned executive and investor who has founded and sold several successful companies to large medical device companies including Baxter, St. Jude Medical, General Electric, and Medtronic. A group led by Mr. Jenkins is expected to make an investment in Hancock Jaffe upon the signing of a definitive merger agreement, and following the closing of the merger transaction
A group led by Mr. Jenkins is expected to make an investment in Hancock Jaffe upon the signing of a definitive merger agreement, and following the closing of the merger transaction.
Mr. Adler has over 35 years of medical device experience including clinical studies, regulatory affairs, sales, and executive management. Over the course of his career, Mr. Adler has been responsible for more than 30 medical devices that have received regulatory approvals, and has led several commercial product launches.
Robert Berman, Hancock Jaffe's CEO stated, "We are excited about the prospect of aligning ourselves with David Jenkins, Steve Adler and their talented team. We believe the proposed merger will be an important first step in creating a diversified medical device company that will appeal to investors and maximize shareholder value.
https://ir.hancockjaffe.com/press-releases/detail/66/hancock-jaffe-announces-intention-to-merge-with-catheter
HERE’S BERMAN’S EMAIL ABOUT THE CDC’s RESPONSE:
BERMAN IS SAYING HE’S BEEN IN TOUCH WITH THE CDC MANY TIMES AND THEY ASSIGNED A “LOWER LEVEL PERSON TO SPEAK WITH THEM,” - - “WHEN THEY DO.” THE CDC AND BERMAN NEVER SPOKE. BE VERY CAREFUL AND SAVE YOURSELVES. BERMAN IS WITHHOLDING INFORMATION FROM THE PUBLIC. THESE ARE FACTS.
CE MARK IS IMMINENT.
HERE WE GO: “Gottlieb said that lateral flow tests, which provide a readout on a device like a pregnancy test, could be coming onto the U.S. market soon.” https://www.cnbc.com/2020/08/17/dr-scott-gottlieb-touts-yale-new-saliva-based-coronavirus-test.html
You will thank me later.
WATCH WHAT WILL HAPPEN WITH E25bio. The virus is zoonotic. Immunity doesn’t last long. And the virus mutates. And the virus is air-borne. Wait and see.
Codiagnostics 1-500 PCR is 45 mins w/o process time. 45 mins / 10.5 secs = 257 Genviro tests. CALCULATE AFTER SELLING MULTIPLE GENVIROS x 257 Tests, every 10.5 secs / every 45 mins = there will be massive backlogs again. BECAUSE WE HAVE MULTIPLE COMPANIES CONDUCTING MULTIPLEX PCRS THAT CANNOT KEEP PACE, MAIL-IN TESTS WILL ONLY INCREASE BACKLOGS IN A MASSIVE WASTE OF TIME THAT WILL ONLY AMOUNT TO MORE WAITING AND BACKLOGS AND BOTTLENECKS. THIS IS A GUARANTEED MATHEMATICAL CERTAINTY.
604,800 seconds / 10.5 seconds = 57,600 tests.
1 week = 604,800 seconds; Genviro = 10.5 seconds. 604800 seconds / 10.5 seconds = 57,600 tests.
Mail-in PCR test compared w/10.5 secs EIS test = major backlog again.
DECN To Be Scooped Up In All Cash Transaction By Unnamed Nasdaq Traded Company, Official PR Coming Early Next Week
https://twitter.com/StockWatchHQ/status/1294760000485654528
"If there is a good idea, I want to hear it. We use investments. We use the (Defense Production Act). We do everything. So, you know, and I kind of feel OK because when Dr. Jha come on TV and attacks whether I care about this country and my patriotism, I figure if you have to stoop that low, the rest of the things must be doing OK," Giroir said.
https://www.cnn.com/2020/08/14/politics/us-coronavirus-testing-trump-administration-cnntv/index.html
"Yes, we want to increase testing. There is no physical way to do 5 million tests per day in this country. If there's a way to turn it from 1 million to 5 million today, let me know," Adm. Brett Giroir told CNN's Pamela Brown on "The Lead."
Pressed if the Trump administration had exhausted its executive authority to acquire additional supplies for labs processing Covid-19 tests, Giroir said, "I'm going to say, definitively, yes."
"If there is a good idea, I want to hear it. We use investments. We use the (Defense Production Act). We do everything. So, you know, and I kind of feel OK because when Dr. Jha come on TV and attacks whether I care about this country and my patriotism, I figure if you have to stoop that low, the rest of the things must be doing OK," Giroir said.
https://www.cnn.com/2020/08/14/politics/us-coronavirus-testing-trump-administration-cnntv/index.html
Hello Dr. Giroir:
At Decision Diagnostics we can assure Covid-19 point of care test results in 10.5 Seconds on the spot. We have a cost effective and efficient solutions to reduce and eliminate the excess waiting periods with the current testing backlogs.
And our dual COVID-19 test platform is saliva and blood interchangeable. We have a solution that will dramatically reduce and ultimately eliminate the excessive costs, resource burdens and bottlenecks resulting from the current testing models and supply shortages.
We have an on the spot technology that will never encounter the supply shortages and excessive costs and burdens from the current testing supply shortages. Our technology is not in short supply. We are abundantly available with accurate precision.
Please contact us for demonstrations to quickly implement our viable and cost effective solution to removes the burdens from the current testing bottlenecks, costs and backlogs.
We can provide accurate results on the spot results in 10.5 seconds with our specialized dual COVID-19 detection methodologies.
Please contact: Decision Diagnostics Chief Executive Officer, “Keith Berman” at:
Phone: 805.446.1973
Fax: 805.446.1983
Email: info@pharmatechsolutions.co
Or please contact Decision Diagnostics Public Relations, Mr. Shep Doniger at:
Shep Doniger at 561-637-5750 or sdoniger@bdcginc.com
Thank you,
Forty percent of U.S. Covid-19 tests come back too late to be clinically meaningful, data show.
CNBC and Dynata ran a survey of more than 9,400 Americans in all 50 states to get a sense of testing turnaround times for Covid-19.
Experts say results need to be returned in less than three days, optimally two, to be clinically meaningful.
The results showed almost 40% of tests take longer than that.
https://www.cnbc.com/2020/08/15/forty-percent-of-us-covid-19-tests-come-back-too-late-to-be-clinically-meaningful-data-show.html
Hello Dr. Giroir:
Amidst the COVID-19 crisis and testing backlog exists a highly helpful technology to aid in solving preventable COVID-19 testing bottlenecks, cost effectively and conveniently increasing test result efficiency.
A 10.5 second COVID-19 detection test, named “GenViro Swift” that can detect the virus in Saliva or Blood.
The Genviro Swift is designed and offered by “Decision Diagnostics / Pharma Tech Solutions.” Here is the website: https://pharmatechsolutions.co/genviro.html
Once implemented the Genviro Swift returns results, in 10.5 seconds through ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY, that is also recognized as as a sensitive and effective means of virus detection by the Department of Health and Human Services as also described in the following website:
https://stacks.cdc.gov/view/cdc/79494/cdc_79494_DS1.pdf
Please contact: Decision Diagnostics Chief Executive Officer, “Keith Berman” at:
Phone: 805.446.1973
Fax: 805.446.1983
Email: info@pharmatechsolutions.co
Or please contact Decision Diagnostics Public Relations, Mr. Shep Doniger at:
Shep Doniger at 561-637-5750 or sdoniger@bdcginc.com
Thank you,
“The company has recently completed the packaging and package inserts for four versions of its GenViro! Product, GenViro! Point of Care, GenViro! At-Home use, GenViro! Saliva Point of Care, and GenViro! International in English, Spanish, French, German and Russian languages for Saliva. The company is in the process of having the UPC clearing house GS-1 assigning UPC identifiers to these four products, all of which will be produced for testing and registration purposes as “Investigational Use” products. An example is given below for illustrative purposes. The kit shown below will be used in the second of testing studies. The kit below will not be sold commercially. The company’s retail kits will include three test strips, three lancets (blood) or three saliva cylinders (saliva) an interface sleeve to cut down human fluid contamination at the meter, and the meter itself.”
https://backend.otcmarkets.com/otcapi/company/financial-report/254965/content
“The design above makes use of a virus antigen approach favored by some of the competitive companies in the Covid-19 testing field, but, as it turns out, not a favorite method at the FDA which favors PCR, a 35+ year old standard. The major difference (magic) is that the approach used by the company in its GenViro! product allows for swift (10.5 seconds or less) results using a minimum of blood from a finger prick, or an equally small amount of saliva from a human subject. All work commenced on the product specification chosen by Mr. Berman with components such as the platinum electrodes, platinum carbon paste, industrial films (several types) to make the biosensor, and perhaps a new impedance chip for the meter. Prototypes of the test strip and the metering device were employed and test strips for investigational testing were delivered to the company on August 2, 2020. Additional test strips in somewhat larger quantity will be delivered on or about August 24. The company is in the process of finalizing a clinical testing agreement with a potential partner, an east coast based testing lab with their own previously authorized Covid-19 test. The parties are working toward a clinical start date of September 1, 2020.
For FDA EUA filing and the granting of a Pre-EUA by the FDA, the company first filed an application for its Professional use version of its GenViro! Covid-19 test kit on April 3. We received PEUA designation from the FDA on April 4. Conversations with FDA review staff began in earnest on April 14. This application was for the point of care testing of blood from human subjects. The company then filed a second EUA application with the FDA on May 1. This application was for our individual use GenViro! test kits. We received PEUA designation from the FDA on May 2. Further, the company plans to file a third EUA application for its GenViro! saliva based method, but this time will hold off on the application until the testing trials are complete and file the application along with the data.
The specifications guidelines set down by Mr. Berman, for creating this Covid-19 testing device and its important chemistry, were that the test must be measured on the company’s existing Precise or Avantage glucometer mold, along with changes to the electronics in the meter, and the differences in test strip size and configuration, to reflect the higher powered electrodes required for virus detection using small (fingertip) samples of whole blood. Later, and just recently the company also added testing using saliva to its kits. In addition, the resulting chemistry would necessarily run using a patients (small sample of) whole blood taken from a finger prick, or saliva taken from a capture tube, found in advanced testing to be 1-2 microliters of fluid (a small drop on a finger tip for blood, and a small amount in a saliva capture cylinder), to perform the test and provide a result in one minute or less (later redefined in two iterations to its current 10.5 seconds or less), with at least a 95% accuracy (the newest FDA guidelines). It should be noted that the company’s virus detection methodology for human saliva which makes use of all of the components in the original GenViro! chemistry (test strip) itself as well as the meter. Three alternative designs were provided and given to the company on March 2. Two of the designs were diagrammed by Mathew Musho, PhD (see below), the third design by a chemist and engineer from The Bio in Korea. The chosen of the three alternative product designs beared the trade name GenViro! Swift.”
https://backend.otcmarkets.com/otcapi/company/financial-report/254965/content
ELECTROCHEMICAL IMPEDANCE PROPOSED BY HHS: https://stacks.cdc.gov/view/cdc/79494/cdc_79494_DS1.pdf
GenViro Blood, not saliva, probably requires FDA Clearance.
GenViro Saliva is FDA regulation exempt; can sell immediately.
OFFICIALLY EXEMPT FROM FDA REGULATION $$$$$$$$
“..an RUO is essentially unregulated by FDA.”
In any event, aside from bearing the mandated statement, RUO products are not regulated by the agency. For example, they do not need to be listed with FDA or comply with the Quality System Regulation (QSR). They can be sold without any FDA clearance or approval. As a practical matter an RUO is essentially unregulated by FDA.
https://www.genengnews.com/magazine/129/oversight-of-research-use-only-products/
EXACTLY! . Regulatory Requirements for Research Use Only and Investigational Use Only IVD products
Section 520(g) of the FD&C Act, 21 U.S.C. 360j(g), provides for the exemption of devices intended for investigational use from certain requirements of the Act if such devices comply with the procedures and conditions prescribed by that section and by regulation. For example, devices intended for investigational use that meet applicable requirements may be exempted from premarket notification and premarket approval requirements of sections 510, 515, 520(g)(2)(A) of the Act (21 U.S.C. 360, 360e, 21 U.S.C. 360j(g)(2)(A)); see also 21 CFR 812.1(a). A product’s intended use refers to the “objective intent” of those responsible for labeling the product.4 Intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.5
Device Investigations Subject to IDE Regulation
FDA's investigational device exemption (IDE) regulation is found at 21 CFR part 812. Under 21 CFR 812.5, investigational devices must bear a label that states the following: "CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use." The labeling may not represent that the device is safe or effective for the purposes for which it is being investigated. 21 CFR 812.5(b). The IDE regulation also prohibits certain conduct by sponsors and investigators pertaining to the investigation and distribution of investigational devices, among other practices. See 21 CFR 812.7.
Device Investigations Exempt from IDE Regulation
Investigations of diagnostic devices that meet the criteria at section 812.2(c)(3) are exempt from the regulations at 21 CFR 812, with the exception of section 812.119. The criteria at section 812.2(c)(3) include specifying that testing:
4 See, 21 CFR 801.4 5 See, id.
5
Contains Non-binding Recommendations
• be non-invasive,
• not require an invasive sampling procedure that presents a significant risk,
• not by design or intention introduce energy into a subject, and
• not be used as a diagnostic procedure without confirmation of the diagnosis by
another, medically established diagnostic product or procedure.
WE ARE GOLDEN!