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Can I look at a recording of this CEO? Got in late heard that VNTH has gotten from an investor a 7 figure investment in this company million or more.
2pm PST. Add the three hour difference for the east coast and you have 5pm EST.
NEWS -- Video River Networks is pleased to unveils New Company Name: Tytan Cybernetics Incorporated
TORRANCE, CA, Oct. 05, 2021 (GLOBE NEWSWIRE) -- Video River Networks “the Company” (OTC: NIHK TWTR: @NIHKEV), a technologically innovative Electric Vehicle and Battery holding company, proudly unveils new Company Name: Tytan Cybernetics Incorporated.
“The rate of expansive growth of the Company developing Electric Vehicles, Drones, with Fintech and Crypto Divisions, has inspired us to rename the Company Tytan Cybernetics Incorporated to reflect our evolution as an emerging powerhouse in innovative technologies. Tytan Cybernetics captures our commitment to fueling state-of-the-art advancements in active growth sectors for years into the future.” CEO Frank Igwealor.
As the Company processes the formal transition to Tytan Cybernetics, the Company will refer to its name as Tytan Cybernetics/Video River Networks in the near future to allow our clients, Shareholders and the Community time to adjust to the new name.
For more information, please join the Shareholder Conference Call scheduled for Friday, October 8th at 2pm PST on Zoom. The link will be posted on the official company Twitter account one hour before the call begins. Please email mailto://AskCEOfrank@gmail.com for additional information.
About Tytan Cybernetics/Video River Networks
Tytan Cybernetics/Video River Networks is an Electric Vehicles and Battery Technology company whose focus is to develop and bring to market the next generation of high-performance state-of-the-art Electric Vehicles. The company’s current and expanding technology portfolio includes Electric Vehicles, Artificial Intelligence, Machine Learning and Robotic ("EV-AI-ML-R") assets, with businesses and operations in North America and Asia. With a commitment to revolutionary technology, Tytan Cybernetics/Video River Networks is in the process of cultivating innovative technologies to enhance consumer’s experience.
For more information, please check the latest updates on the company's Twitter account https://twitter.com/NIHKEV
About Chairman and CEO Frank Igwealor
With a passion for building businesses by the community for the community, Chairman and CEO Frank Igwealor is committed to the realization of technological and social inventions that benefit society and empower the less-privileged. With a focus on diversity and social-entrepreneurship, CEO Frank devotes his time to developing businesses that empower the less-privileged to become financially self-sufficient, “realizing the humanity of tomorrow begins with the dreams of today”.
Notice Regarding Forward Looking Statements
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release contains forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words “believes,” “expects,” “anticipate” or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.
CONTACT:
Tytan Cybernetics/Video River Networks
370 Amapola Ave., Suite 200A
Torrance, CA 90501
mailto://contact@videorivernetworks.net
Nighthawk Systems is the old name before video river .
NEWS -- BTHE Quarterly Report (10-q)
https://ih.advfn.com/stock-market/USOTC/boston-therapeutics-pk-BTHE/stock-news/86215611/quarterly-report-10-q
NEWS -- NanoViricides Provides Update on Its Pan-Coronavirus COVID-19 Drug Development Program at Benzinga Healthcare Small Cap Conference
SHELTON, Conn., Oct. 5, 2021 /PRNewswire/ -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, presented an update of its Pan-Coronavirus COVID-19 Drug Development Program at the Benzinga Healthcare Small Cap Conference on September 30, 2021 at 10:10am EST.
In the "Pan-coronavirus Broad-spectrum Nanomedicines NV-CoV-2 and NV-CoV-2-R to Attack the SARS-CoV-2 Virus and its Variants in the Global Pandemic" presentation, Dr. Diwan discussed the current status of NanoViricides' COVID-19 drug development program.
An updated Corporate Presentation that encompasses Dr. Diwan's presentation at the Benzinga Conference will be available shortly on the Company's website on its home page (https://www.nanoviricides.com).
Highlights of the Presentation:
Did anyone get the DRNG shares yet?
Video River Networks
@NIHKEV
·
25m
$NIHK's new name coming out tomorrow. To be followed by a Cussip change, and a trip to FINRA for Ticker Change. While getting ready to receive the first batch of our EV samples. Stay tuned @DroneGuarder
@opportunityzon
@Alpharidge_Cap
@GiveMePower5
NEWS -- Provectus Biopharmaceuticals Provides Update on Research into Oral Administration of PV-10® Immunotherapy for Treatments of Hematology, Oncology, and Virology
KNOXVILLE, TN, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided an update on the Company’s research into the systemic administration of Provectus’ investigational immunotherapy, PV-10 (rose bengal disodium, a halogenated xanthene molecule), for the treatments of hematology, oncology, and virology indications, in conjunction with the Company’s efforts to expand its intellectual property.
Hematology: On August 5, 2021, the U.S. Patent and Trademark Office (USPTO) published Provectus’ patent application entitled “Composition and Method for Oral Treatment of Leukemia” (publication no. US 2021/0236418 A1), containing:
NEWS -- Promising New OpRegen® Clinical Data Featured at 54th Annual Retina Society Meeting in Podium Presentation by Christopher D. Riemann, M.D.
Statistically Significant Evidence of a Treatment Effect with OpRegen Observed in Cohort 4 Patients
CARLSBAD, Calif., September 30, 2021--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported today that updated interim results from a Phase 1/2a clinical study of its lead product candidate, OpRegen®, an investigational retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), were featured in a podium presentation at the 54th Annual Scientific Meeting of the Retina Society. The presentation, "Phase 1/2a Clinical Trial of Transplanted Allogeneic Retinal Pigmented Epithelium (RPE, OpRegen) Cells in Advanced Dry Age-Related Macular Degeneration (AMD): Interim Results," was presented by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210930005305/en/
Statistically Significant Evidence of Treatment Effect with OpRegen RPE Transplant Over Time (Graphic: Lineage Cell Therapeutics)
Patients enrolled into the clinical study all had bilateral, advanced, atrophic AMD. OpRegen was transplanted into the subretinal space, near or across the area of geographic atrophy (GA) of their worse seeing eyes, and the patients were routinely followed as scheduled per protocol. Data presented today showed that as patients continued to progress into post-operative follow-up, eyes receiving OpRegen trended toward improvement in visual acuity, a secondary objective under the study, while their untreated eyes typically lost visual acuity, as expected with this progressive disease. As additional patients have reached longer periods post-treatment, differences in visual acuity between treated and untreated eyes across Cohort 4 patients became statistically significant beginning at month 9 (P = 0.0085), as well as months 12 (P = 0.0220) and 15 (P = 0.0273) as determined via 2-sided Wilcoxon Signed Rank (using NCSS, LLC statistical software). These results, when combined with the previously reported data from detailed analyses of multimodal imaging, including optical coherence tomography (OCT), which showed evidence of retinal restoration in areas previously considered to be atrophic, suggest that both a structural and functional benefit is possible with OpRegen therapy. Additionally, OpRegen continues to be well tolerated and there have been no new, unexpected ocular or systemic adverse events or serious adverse events.
"This is an exciting time for the OpRegen program, the participating investigative sites, and for patients suffering from dry AMD. The efficacy findings presented today are both statistically significant as well as clinically important," stated Christopher D. Riemann, M.D. "Prior clinical data readouts were mostly descriptive and lacked enough patients and post-treatment follow-up to allow for detailed statistical analyses. A significant number of better vision Cohort 4 patients are now 9, 12, and even 15 months post-treatment with OpRegen. As a result, we were able to analyze the available results to ascertain if a detectable efficacy signal could be observed in a relatively small number of patients. Though this early phase trial is open label, non-randomized and not placebo controlled, the significant differences in visual acuity of patients’ OpRegen treated eyes compared to their fellow, untreated eyes over time is very important. Though larger, controlled studies are needed, OpRegen is a potentially transformational therapy for these patients without any approved treatment options. These results strongly support further late-stage development, and we are eager to begin those studies."
"As more patients in the OpRegen trial reach clinically relevant observation periods, our data set grows larger and permits us to conduct additional analyses like the one reported today. These new data support our view that our cell transplant approach can deliver not only anatomical changes detectable by imaging studies, but also durable functional benefits to visual acuity," stated Brian M. Culley, Lineage CEO. "OpRegen already is well-positioned among product candidates in development for dry AMD as the only one that has demonstrated an ability to halt or reverse the expansion of geographic atrophy and we are additionally reporting statistically significant differences in visual acuity over time between treated and untreated eyes in our intended patient population. We are excited to continue developing OpRegen as a potential treatment for dry AMD with GA."
Dr. Riemann’s presentation will be available on the Events and Presentations section of Lineage’s website (https://investor.lineagecell.com/events-and-presentations/upcoming-events).
The Retina Society was founded in 1968 exclusively for educational and scientific purposes concerning the diagnosis, care and treatment of diseases and injuries to the retina. For more information on the Retina Society or its annual scientific meeting, please visit https://www.retinasociety.org/ or follow the association on Twitter @RetinaSociety.
About OpRegen
OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with BCVA of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events that have not been previously reported. OpRegen is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of Lineage Cell Therapeutics, Inc.
About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch's membrane and the RPE, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no U.S. Food and Drug Administration (FDA), or European Medicines Agency, approved treatment options available for patients with atrophic AMD.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential benefits of treatment with OpRegen in dry AMD patients with GA, the significance of clinical data reported to date from the ongoing Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration, Lineage’s plans to meet with the FDA to discuss OpRegen’s clinical development, the potential utilization of OCT imaging to measure efficacy in a pivotal clinical trial of OpRegen for the treatment of dry AMD with GA, and the potential for Lineage’s investigational allogeneic cell therapies to provide safe and effective treatment for multiple, diverse serious or life threatening conditions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210930005305/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Plus Therapeutics to Present ReSPECT™-GBM Clinical Trial Data at the 2021 SNO Annual Meeting
AUSTIN, Texas, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced it will present interim data on Rhenium-186 NanoLiposome (186RNL) from its ReSPECT™ Phase 1 clinical trial in recurrent glioblastoma (GBM) at the 2021 Society for Neuro-Oncology (SNO) Annual Meeting and Education Day being held November 18-21, 2021 in Boston, Massachusetts.
Details of the abstract and poster session are as follows:
Accepted abstracts will be made available on Thursday, November 11, 2021 at https://academic.oup.com/neuro-oncology/issue/22/Supplement_2.
A copy of the poster will be made available under the Presentations tab of the Investors section of the Company’s website at the time of the presentation at https://ir.plustherapeutics.com.
About Plus Therapeutics, Inc.
Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to formulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “will,” “believe,” “plan,” “can,” “enable,” “design,” “intend,” “potential,” “expect,” “estimate,” “project,” “prospect,” “target,” “focus,” “anticipate,” “could,” “should,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs; the potential of the Company’s in-licensed portfolio of investigational drugs; the Company’s intent to advance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation directly into the brain tumor; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; and the Company’s anticipated milestones and events, including with respect to additional sites, enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, and partnership discussions for RNL, DocePLUS and DoxoPLUS; and future development and/or expansion of its product candidates and therapies in its markets. The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the FDA’s accelerated regulatory pathways; the early stage of the Company’s product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s history of losses; the Company’s need for, and ability to raise, additional cash or obtain other sources of funding in the immediate future; the Company’s ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Company’s partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
Facebook founder Mark Zuckerberg — Age 19 when he started his company!
CEO David Kittle is a ZUCKERBERG 2.0
The new CEO is a cryptocurrency genius , if a major news network covers this stock and interviews him every computer geek will buy VNTH , this could be worth multi-billions by next year .
NEWS -- Navidea Biopharmaceuticals Appoints Michel Mikhail, Ph.D. as Chief Regulatory Officer
DUBLIN, Ohio, September 27, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the appointment of Michel Mikhail, Ph.D. as Chief Regulatory Officer of Navidea, effective October 1, 2021.
Dr. Mikhail has more than 30 years of experience in the pharmaceutical industry and a track record of achievement in R&D and international regulatory affairs at large multinational research-based pharmaceutical companies. Prior to joining Navidea, Dr. Mikhail worked in global regulatory consulting for various pharmaceutical and biotech companies from January 2016 through September 2021. Before acting as a consultant, Dr. Mikhail served in senior regulatory executive roles at BioNTech AG, Fresenius Kabi, Ranbaxy Europe Ltd. (now SunPharma), Pharmacia & Upjohn (now Pfizer), Knoll AG (now Abbvie), SmithKline Beecham (now GlaxoSmithKline), and Boehringer Ingelheim. Dr. Mikhail is a global expert in Regulatory Affairs dealing with the U.S. Food and Drug Administration ("US-FDA"), the European Medicines Agency ("EU-EMA") as well as national agencies in Europe, Japan’s Pharmaceuticals and Medical Devices Agency, China’s National Medical Products Administration, among other regulatory agencies worldwide. He is a Chartered Expert in Pharmacology-Toxicology. Dr Mikhail served on the Safety working group and Efficacy working group of the European Federation of Pharmaceutical Industry Associations and as a Topic Leader for new guidelines. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America, on the European Biosimilars Group, the Regulatory and Scientific Affairs Group of the European Generic medicines Association (now Medicines for Europe), as well as on different associations and organizations. Dr. Mikhail is a lifetime member of The Organization for Professionals in Regulatory Affairs, and has contributed as volunteer at the Drug Information Association and the Parenteral Drug Association. Dr. Mikhail was part of the Transatlantic Trade and Investment Partnership negotiations aiming at harmonization of regulatory requirements and relying on each other’s inspections between the EU-EMA and US-FDA. Dr. Mikhail served as a volunteer member of the Expert Committee of the Governmental Federal Institute of Risk Assessment in Berlin, Germany and served as a volunteer member of the Expert Committee for Toxicology of the United States Pharmacopoeia in Maryland, USA. Dr. Mikhail holds a Ph.D. from the University of Paris and a Ph.D. from the University of Hannover.
Dr. Mikhail said, "This is an exciting opportunity to join Navidea’s leadership team, to expand the product portfolio leveraging on the diagnostic imaging and the therapeutic Manocept platform. I look forward to working with the US-FDA, the EU-EMA and regulatory agencies around the world and with the Navidea development teams and partners to deliver on Navidea’s drug development initiatives, ensuring they are completed and approved on time and to the highest quality standards that can lead to positive patient impact. I am proud to join a world-class team to support Navidea’s anticipated growth, as we execute on our mission of helping patients have the right effective medicine from the start to treat their disease, minimizing exposure to unwanted side effects and saving cost for the payers."
Navidea Chief Executive Officer Jed Latkin said, "We are very pleased to welcome Dr. Michel Mikhail to our executive leadership team, as he brings over 30 years of expertise in the field of global regulatory affairs and drug development. He has experience in accompanying drug development through regulatory agency meetings and scientific advice, from start until successful completion of Phase 3 clinical trials as well as indication expansion and successful approval by regulatory authorities. We look forward to a successful development and implementation of regulatory strategy for development and expansion of our Manocept platform to enhance patient care and contribute to covering unmet medical needs for drug imaging technology and therapeutic use in rheumatoid arthritis and beyond."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210927005202/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Plus Therapeutics to Present at the Benzinga Healthcare Small Cap Conference
AUSTIN, Texas, Sept. 27, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced that Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics, will present a Company overview during the Benzinga Healthcare Small Cap Conference on Thursday, Septemeber 30, 2021 at 4:20 p.m. ET.
Company management will also be available for one-on-one meetings throughout the conference.
To access the presentation, please register at https://www.benzinga.com/events/small-cap/healthcare/. In addition, a replay of the presentation will be available under the ‘Events’ tab of the Investor Relations section of the Plus Therapeutics website at https://www.plustherapeutics.com.
About Plus Therapeutics, Inc.
Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “will,” “believe,” “plan,” “can,” “enable,” “design,” “intend,” “potential,” “expect,” “estimate,” “project,” “prospect,” “target,” “focus,” “anticipate,” “could,” “should,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs; the potential of the Company’s in-licensed portfolio of investigational drugs; the Company’s intent to advance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation directly into the brain tumor; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; and the Company’s anticipated milestones and events, including with respect to additional sites, enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, and partnership discussions for RNL, DocePLUS and DoxoPLUS; and future development and/or expansion of its product candidates and therapies in its markets. The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the FDA’s accelerated regulatory pathways; the early stage of the Company’s product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s history of losses; the Company’s need for, and ability to raise, additional cash or obtain other sources of funding in the immediate future; the Company’s ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Company’s partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- NanoViricides, Inc. Invites You to Join Us at the Benzinga Healthcare Small Cap Conference for Update on Pan-Coronavirus COVID-19 Drug Development Program
Shelton, Connecticut--(Newsfile Corp. - September 27, 2021) - NanoViricides, Inc. (NYSE American: NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, will be presenting at the Benzinga Healthcare Small Cap Conference taking place on-line on September 29-30, 2021.
At 10:10am/ET on September 30th, NanoViricides is scheduled to present a talk on "Pan-coronavirus Broad-spectrum Nanomedicines NV-CoV-2 and NV-CoV-2-R to Attack the SARS-CoV-2 Virus and its Variants in the Global Pandemic".
FREE spectator passes are available at https://www.benzinga.com/events/small-cap/healthcare/. We invite our shareholders and all interested parties to join us!
What: Benzinga Healthcare Small Cap Conference - NanoViricides
When: Thursday, September 30, 2021 - 10:10 am - 10:30 am/ET
Who: Anil Diwan, Ph.D. - President & Chairman - NanoViricides, Inc.
Event Website: https://www.benzinga.com/events/small-cap/healthcare/.
About the Benzinga Healthcare Small Cap Conference
The Benzinga Healthcare Small Cap Conference bridges the gap between Small Cap companies, investors, and traders. Learn about small cap investing with clearly defined Educational Modules, take a look at a curated group of Small Cap investment opportunities, and connect with the healthcare Small Cap audience in an intimate, virtual setting. We invite investors and all interested parties to explore healthcare small cap investment opportunities through two days of networking, dealmaking and discovery. For more information and/or to register for the conference please visit: https://www.benzinga.com/events/small-cap/healthcare/.
About NanoViricides
NanoViricides, Inc. (the "Company") (http://www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. We are developing clinical candidates for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, the Company has several antiviral programs in various pre-clinical stages.
The Company is now working on tasks for completing an IND application for its COVID-19 drug candidates. The Company cannot project an exact date for filing an IND for this drug because of its dependence on a number of external collaborators and consultants. The Company is currently pursuing two separate drug candidates for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2 with remdesivir encapsulated in it. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.
The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: human Coronavirus infections, Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus and Ebola/Marburg viruses. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines.
Contact:
NanoViricides, Inc.
mailto://info@nanoviricides.com
http://www.nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
mailto://clyburn@tradigitalir.com
Source: NanoViricides, Inc.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/97693
NEWS -- Provectus Biopharmaceuticals Announces Acceptance of PV-10 Poster Presentations at Society for Melanoma Research (SMR) 2021 Congress
KNOXVILLE, TN, Sept. 27, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that data from historical clinical trials and expanded access studies of investigational cancer immunotherapy PV-10 (rose bengal disodium) for the single-agent treatment of Stage III melanoma (NCT00521053, NCT01260779, and NCT02288897) and an ongoing clinical trial of PV-10 combination therapy for the treatment of Stage IV melanoma (NCT02557321) will be presented on two poster presentations at the SMR 2021 Congress (the Society for Melanoma Research annual meeting) to be held online from October 28-31.
The two accepted abstracts are:
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NEWS -- Plus Therapeutics to Present Rhenium-186 NanoLiposome Data at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting
AUSTIN, Texas, Sept. 23, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced it will present data regarding its Rhenium-186 NanoLiposome (186RNL) investigational radiotherapeutic for recurrent glioblastoma (GBM) at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting being held in person October 24-27, 2021 in Chicago, Illinois.
Details of the abstract and poster viewing Q&A session are as follows:
Title: Image-guided Rhenium-186 NanoLiposome (186RNL) brachytherapy in the treatment of recurrent glioblastoma: technique, image analysis, dosimetry, and monitoring
Date: October 27, 2021 at 1:00 p.m. CT / 2:00 p.m. ET
Location: McCormick Place West, Outside Room W375
Presenter: John Floyd, M.D., University of Texas Health Science Center San Antonio, and study investigator
The abstract and poster will be accessible online in the ASTRO conference planner on October 22, 2021 at 5:00 p.m. CT / 6:00 p.m. ET. A copy of the poster will be made available under the Presentations tab of the Investors section of the Company’s website at the time of the presentation at https://www.plustherapeutics.com.
About Plus Therapeutics, Inc.
Where: Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “will,” “believe,” “plan,” “can,” “enable,” “design,” “intend,” “potential,” “expect,” “estimate,” “project,” “prospect,” “target,” “focus,” “anticipate,” “could,” “should,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs; the potential of the Company’s in-licensed portfolio of investigational drugs; the Company’s intent to advance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation directly into the brain tumor; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; and the Company’s anticipated milestones and events, including with respect to additional sites, enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, and partnership discussions for RNL, DocePLUS and DoxoPLUS; and future development and/or expansion of its product candidates and therapies in its markets. The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the FDA’s accelerated regulatory pathways; the early stage of the Company’s product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s history of losses; the Company’s need for, and ability to raise, additional cash or obtain other sources of funding in the immediate future; the Company’s ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Company’s partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Vivos Inc Completes Certification Training Modules for Future IsoPet® Therapy Regional Clinics
Richland WA, Sept. 22, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc working with FX Masse completed nine certification training modules that are part of the certification training for new regional clinics.
The modules are now on the FX Masse website with a separate unique UR web browser for Vivos Inc. This required a substantial investment in effort but the approach will be very cost effective. A new clinic can complete each module at their convenience as a pre-cursor to the hands-on certification training sessions. This certification will be linked to their radioactive material handling licenses.
Dr. Mike Korenko stated, “We were fortunate to team with this contractor to capitalize on their experience on producing these modules. They will also assist with the licensing. We needed to create an efficient and consistent process to initiate the establishment of regional clinics for IsoPet® therapy.”
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90 based injectable brachytherapy device, for the treatment of tumors in animals (IsoPet®) and in humans (RadioGel™). Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel technology. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows safe delivery of higher doses needed for treating both non-resectable and radiation-resistant cancers.
RadioGel™ is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. The hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
RadioGel™ also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation dose to family members.
The IsoPet® Solutions division used university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. Testing on feline sarcoma at the Washington State University was completed in 2018 and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019.
In 2018 the Company obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices so no additional approval is required. Following the demonstration phase, Vivos is able to generate revenue through the sale of IsoPet® to University animal hospitals and private veterinary clinics.
IsoPet® for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
mailto://MKorenko@RadioGel.com
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
mailto://MKorenko@RadioGel.com
NEWS -- Significantly Improved Safety Profile and Metabolism of Remdesivir Observed Due to Encapsulation in NanoViricides Drug Candidate Enabling Potential Highly Effective Pan-Coronavirus Antiviral Drug
SHELTON, Conn., Sept. 22, 2021 /PRNewswire/ -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today on the significant advantages gained by remdesivir encapsulation within its lead COVID-19 candidate NV-CoV-2 thereby resulting in the dual-acting drug candidate NV-CoV-2-R with the promise of a potential pan-coronavirus cure.
Pharmacokinetics of Encapsulated Remdesivir Compared to Standard Formulation
Almost double the amount of remdesivir remained intact in plasma when given as the encapsulated NV-CoV-2-R form, in comparison to the standard remdesivir formulation made in betadex sulfobutyl ether sodium (SBECD), during the first day of dosing in a rat pharmacokinetics study. Additionally, remdesivir accumulation was observed on repeated dosing of NV-CoV-2-R. After the fifth dose of NV-CoV-2-R (on day 7), in comparison to the standard remdesivir dosing pattern (twice on day 1 followed by daily thereafter; on day 7), the circulating level of intact remdesivir in plasma was 75% greater in the NV-Cov-2-R group as compared to the standard remdesivir group. The data were normalized to reflect the same amount of remdesivir given to the animals per kg body weight for uniform comparison. The assays were performed using the well-established isotopic internal standard method of remdesivir estimation with LCMS detection.
The increased circulating level of intact remdesivir when given as NV-CoV-2-R encapsulated formulation without any increase in toxicity is significant. It can be expected to result in improved antiviral effectiveness of the remdesivir component in human usage of NV-CoV-2-R treatment. This is important because remdesivir is a highly effective drug in cell culture and pre-clinical studies but does not show clinical effectiveness in humans at levels that would be expected based on its cell culture efficacy because of its rapid metabolism. Additionally, there is very little margin to increase remdesivir dosing in its standard formulation because of dose limiting toxicity.
NV-CoV-2-R was found to be less toxic than the standard remdesivir formulation in this study. At day 7, when a total of 80mg/kg remdesivir was dosed in the standard formulation, the body weight loss was approximately 9.5% in male and 9.5% in female animals. In contrast, when 80mg/kg of remdesivir was delivered as NV-CoV-2-R encapsulated formulation, at day 7, the weight loss was only approximately 3% in male animals and 1% in female animals which was the same as with the vehicle treatment reflecting injection trauma itself and no drug toxicity.
These data demonstrate that the pan-coronavirus nanoviricide drug candidate NV-CoV-2-R substantially decreases the loss of remdesivir to bodily metabolism in comparison to the standard formulation. The Company anticipates that this stabilizing effect should lead to a highly effective pan-coronavirus drug that could potentially cure most cases of COVID-19 infection.
Both remdesivir and NV-CoV-2 have demonstrated broad-spectrum activity against coronaviruses. Thus NV-CoV-2-R is expected to continue to be active in spite of evolution of novel variants of SARS-CoV-2. In contrast, antibody drugs and vaccines which induce antibodies lose effectiveness against variants. The more the variant drifts from the original strain, the less protection is offered by vaccines, and effectiveness of antibodies also diminishes significantly. This is now known to be occurring for current vaccines and antibodies during the global COVID-19 pandemic.
NV-CoV-2-R combines (1) the power of the nanoviricides® platform attacking the virus particle outside cells with (2) the power of remdesivir in attacking the virus reproduction inside cells. Additionally, we believe that (3) NV-CoV-2-R would be improving the effect of remdesivir by (a) enabling a higher effective concentration of remdesivir in the body and (b) sustaining this higher concentration for a substantially longer period of time, both compared to the standard formulation of remdesivir, as observed in this pharmacokinetic animal study.
NV-CoV-2-R combines two different mechanisms of attack against the virus and therefore is expected to be substantially more difficult for the virus to evade than either NV-CoV-2 or remdesivir alone. This is important because scientists believe it is only a matter of time before variants of SARS-CoV-2 that evade current vaccines and antibody drugs become commonplace.
Both NV-CoV-2 and remdesivir are expected to retain their effectiveness against variants of SARS-CoV-2. NV-CoV-2 has shown effectiveness against multiple unrelated coronavirus types. Remdesivir has been demonstrated to possess antiviral activity in cell culture against a large number of RNA viruses.
The standard Veklury® formulation of remdesivir in betadex sulfobutyl ether sodium (SBECD) helps with suspending remdesivir in solution, but does not appear to significantly improve upon the metabolic effects. In contrast, NV-CoV-2-R is an encapsulation approach wherein remdesivir would slowly leak out into the bloodstream from the polymeric nano-micelle over time, imparting protection against metabolism and sustained effective levels of the encapsulated drug component over a longer time period.
"We are pleased to report that NV-CoV-2-R encapsulation of remdesivir indeed provided substantially superior pharmacokinetics as per our expectation in designing this drug," said Anil R. Diwan, Ph.D., President and Chairman of the Company, adding, "We believe our drug candidate NV-CoV-2-R is promising to result in a pan-coronavirus cure if successful in clinical trials."
About NanoViricides
NanoViricides, Inc. (the "Company") (https://www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. We are developing clinical candidates for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, the Company has several antiviral programs in various pre-clinical stages.
The Company is now working on tasks for completing an IND application for its COVID-19 drug candidates. The Company cannot project an exact date for filing an IND for this drug because of its dependence on a number of external collaborators and consultants. The Company is currently pursuing two separate drug candidates for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2 with remdesivir encapsulated in it. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.
The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: human Coronavirus infections, Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus and Ebola/Marburg viruses. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines.
SOURCE NanoViricides, Inc.
NEWS -- Provectus Biopharmaceuticals Announces Presentation of Full Study Data from Metastatic Neuroendocrine Cancer Phase 1 Trial of PV-10® at European Society for Medical Oncology (ESMO) Congress 2021
KNOXVILLE, TN, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that data from an ongoing clinical trial of investigational cancer immunotherapy PV-10 (rose bengal disodium) for the treatment of neuroendocrine tumors (NET) metastatic to the liver (mNET) refractory to somatostatin analogs (SSAs) and peptide receptor radionuclide therapy (PRRT) (NCT02693067) was presented at the European Society for Medical Oncology (ESMO) Congress, held online from September 16-21, 2021.
Highlights from the ESMO 2021mNET Presentation:
NEWS -- Vivos Inc. Files Early Feasibility IDE Application with FDA for Radiogel™
Richland WA, Sept. 20, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc. is pleased to announce that it has submitted the IDE, Investigational Device Exemption for The Early Feasibility Medical Device Study, First in Human Study for Y-90 RadioGel™, to the Food and Drug Administration as part of a pre-submission meeting process. The FDA recommended this path to facilitate enhanced ongoing communication with Vivos and to increase the efficiency of the review process. This review typically takes several iterations and we will continue with biocompatibility testing in parallel.
This filing is an important milestone for Vivos and reflects the efforts of numerous parties. In particular, we are pleased that this IDE filing included the Mayo Clinic Clinical Trial Protocol for Radiogel™, which is currently being reviewed by Mayo’s Independent Review Team.
Dr. Mike Korenko stated, “We were encouraged that the FDA was supportive and we expect them to provide valuable insight to ultimately gain final approval.”
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90 based injectable brachytherapy device, for the treatment of tumors in animals (IsoPet®) and in humans (RadioGel™). Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel technology. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows safe delivery of higher doses needed for treating both non-resectable and radiation-resistant cancers.
RadioGel™ is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. The hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
RadioGel™ also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation dose to family members.
The IsoPet® Solutions division used university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. Testing on feline sarcoma at the Washington State University was completed in 2018 and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019.
In 2018 the Company obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices so no additional approval is required. Following the demonstration phase, Vivos is able to generate revenue through the sale of IsoPet® to University animal hospitals and private veterinary clinics.
IsoPet® for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
mailto://MKorenko@RadioGel.com
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
mailto://MKorenko@RadioGel.com
NEWS -- Oncolytics Biotech® Announces Preclinical Data Demonstrating the Synergistic Immunotherapeutic Effects of Pelareorep Combined with Radiotherapy
NEWS -- Lineage to Present at the 2021 Cantor Virtual Global Healthcare Conference on September 27, 2021
CARLSBAD, Calif., September 20, 2021--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, the Company’s Chief Executive Officer, will be presenting at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference in a fireside chat hosted by Kristen Kluska, Director, Equity Research on September 27th, 2021 at 4pm ET / 1pm PT.
Interested parties can register to view both the on-demand and live industry presentations on the Events and Presentations section (https://investor.lineagecell.com/events-and-presentations/upcoming-events) of Lineage’s website. Additional videos are available on the Media page (https://lineagecell.com/media/) of the Lineage website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210920005302/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Gitanjali Jain Ogawa
(mailto://Gogawa@soleburytrout.com)
(646) 378-2949
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- Video River Networks announces “CEO Updates”: live Shareholder Conference Call with CEO Friday, October 8th, 2021 on Zoom
TORRANCE, CA, Sept. 17, 2021 (GLOBE NEWSWIRE) -- Video River Networks “the company” (OTC: NIHK TWTR: @NIHKEV), a technologically innovative Electric Vehicle and Battery holding company, is pleased to announce the beginning of a live Conference Call series with Shareholders “CEO Updates”, with the first live Shareholder Conference Call with Chairman and CEO scheduled for Friday, October 8th, 2021 at 2pm PST on Zoom.
Topics to be reviewed:
NEWS -- Navidea Biopharmaceuticals Announces Changes to Board of Directors Composition
DUBLIN, Ohio, September 17, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that on September 14, 2021, at a meeting of the Board of Directors (the "Board") of the Company that followed the Company’s 2021 Annual Meeting of Stockholders, S. Kathryn Rouan, Ph.D. retired as Chair of the Board and as a director, and Claudine Bruck, Ph.D. retired as a director, both effective immediately.
Following the retirement of Dr. Rouan as Chair, the Board appointed Alexander L. Cappello and John K. Scott, Jr., who were both existing members of the Board, as Chair of the Board and Vice Chair of the Board, respectively.
Also effective September 14, 2021, the Board appointed Mr. Cappello to the Audit Committee, and therefore the current members of the Audit Committee are Amit Bhalla (Chair), Malcolm Witter and Mr. Cappello. On the same date, the Board appointed Messrs. Cappello and Scott to the Compensation, Nominating and Governance ("CNG") Committee and appointed Mr. Witter as Chair, and therefore, the current members of the CNG Committee are Mr. Witter (Chair), Mr. Scott and Mr. Cappello.
- ADVERTISEMENT -
Jed Latkin, Navidea’s CEO said, "We thank both Kathy and Claudine for their service on the Board and the valuable insights they have provided over the years. With a combined 60 years of experience in the clinical space their contributions helped shape both the diagnostic and therapeutic direction of the Company. We wish them the best in their future endeavors."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at https://www.sec.gov or at http://ir.navidea.com.
Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210917005043/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Data From Ongoing Clinical Trial Continues to Demonstrate a Single Administration of OpRegen® Can Provide Anatomical and Functional Improvements in Patients With Dry AMD With Geographic Atrophy
September 15 2021 - 09:00AM -- Business Wire
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported updated interim results from its ongoing, 24-patient Phase 1/2a clinical study of its lead product candidate, OpRegen. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells, administered in a single surgery to the subretinal space, for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). These updated results include a minimum of 9 months of follow-up in all 12 patients treated in Cohort 4, which as a group had better baseline vision and smaller areas of GA at baseline than earlier cohorts. Overall, in the study (N=24), OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events not previously reported.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210915005401/en/
“I am particularly encouraged by the OCT findings in the second retinal restoration patient. Based on historical growth patterns, we knew this patient was a slower progressor than many other patients enrolled, and therefore less likely to benefit from treatment. Despite this, we have been able to demonstrate a reduction in the atrophic area as quickly as 2 months post-treatment and a marked slowing of disease progression,” stated Jordi Monés, M.D., Ph.D., Director of the Institut de la Màcula and Barcelona Macula Foundation. “Further, even in patients with an incomplete coverage of OpRegen over the primary area of atrophy, we have observed resolution of not only lesions of iRORA (incomplete retinal pigment epithelial and outer retinal atrophy), but also resolution of areas with features of cRORA, which is a state of complete loss of the RPE and outer retinal tissue. Additionally, the structural benefits may help explain the improvement in visual acuity. I eagerly look forward to new data as they are collected.”
“While competing efforts are focused on reducing the growth rate of geographic atrophy, Lineage has reported several patients whose areas of atrophy have stabilized or reduced in size. These observations, which are present across clinically-meaningful periods, indicate a reversal of the degeneration of critical retinal tissue layers which support vision, consistent with the proposed mechanism of an RPE cell transplant. Importantly, all three of the patients exhibiting restoration had confirmed historic growth rate in these areas and these data have been collected using multiple imaging modalities. The durability of the improvements to visual acuity, when coupled with the clear structural improvements we’ve seen in patients which received fuller coverage of OpRegen across their GA, strongly suggest that cell therapy may be able to achieve therapeutic benefits that are beyond the reach of targeted drugs or antibodies," added Brian M. Culley, Lineage CEO. “We are extremely pleased that our data is moving in a positive direction with each interim update we provide. We will continue to collect follow up data and work towards a meeting with FDA to discuss key aspects of our program. Our objective with OpRegen is to demonstrate the potential for allogeneic cell therapy to deliver the best available clinical outcomes and apply our technology to additional areas such as cancer, spinal cord injury, and other attractive opportunities.”
OpRegen Phase 1/2a Interim Clinical Results
NEWS -- Heat Biologics CEO to Present at the Cantor Fitzgerald Global Healthcare Conference on September 29th
September 15 2021 - 07:30AM
Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that Jeff Wolf, Chief Executive Officer of Heat Biologics, will be presenting at the Cantor Fitzgerald Global Healthcare Conference being held virtually between September 27-30, 2021.
Presentation Details:
Date: Wednesday, September 29, 2021
Time: 9:20 AM ET / 6:20 AM PT
Webcast: Cantor Global Healthcare Conference (https://wsw.com/webcast/cantor12/register.aspx?conf=cantor12&page=htbx&url=https://wsw.com/webcast/cantor12/htbx/2096220)
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. Heat’s gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.
For more information, please visit: https://www.heatbio.com, and also follow us on Twitter.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com
NEWS -- NanoViricides Completes Licensing for Coronavirus Field which Includes Current COVID-19 Drug Development
SHELTON, Conn., Sept. 14, 2021 /PRNewswire/ -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), a global leader in nanomedicines against viruses, announced today that it has completed the process of licensing the human Coronavirus field for drug development and commercialization from TheraCour Pharma, Inc. ("TheraCour"). The Company executed a license agreement for the field comprising anti-viral treatments for coronavirus derived human infections with TheraCour Pharma, Inc. on September 8, 2021 (the "Agreement").
NanoViricides is developing oral and pediatric drugs to fight COVID-19 designed to be effective against most variants.
The licensed field includes antiviral drugs to treat SARS-CoV-2 and its variants that cause the COVID-19 disease resulting in a global pandemic that continues to rage through the world, wave after wave, as new variants develop and take hold. There was no upfront cash payment for the license and the compensation terms were generally consistent with prior licenses, and are summarized further below.
NanoViricides is currently working on taking its two COVID-19 lead drug candidates, namely, NV-CoV-2- and NV-CoV-2-R, into human clinical trials. The Company believes that the essential preclinical work is substantially complete for taking these drugs into human evaluation.
The Company believes that these broad-spectrum anti-coronavirus drugs will continue to be effective even as the virus continues to mutate developing into a number of variants of concern. Antibody protection afforded by vaccines and the effectiveness of antibody drugs have continued to decline progressively as new SRAS-CoV-2 variants have emerged. The Company believes that its unique anti-viral nanomachine technology overcomes these issues.
The Company believes it is well poised to deliver an out-patient oral medicine to treat COVID-19 infections. The Company has found that its anti-COVID-19 drugs exhibited strong antiviral effectiveness when given orally in animal studies.
The Company also believes that its COVID-19 drugs will be suitable for use in pediatric patients, and we plan to include pediatric cohorts into clinical trials at the appropriate stages. We believe that pediatric use of these drugs is feasible based on the excellent safety profile we have observed in animal studies. As the variants evolve, pediatric infections and their severity have begun to rise, causing major worldwide concerns even as the world is trying to move towards normalcy in education and child social interactions.
The Company's anti-COVID drugs are based on polymeric micelle nanomedicine technologies developed by TheraCour Pharma, Inc. and its affiliate, AllExcel, Inc. The inventors have filed a PCT patent application that forms the basis of the Company's two lead drug candidates, namely, NV-CoV-2 and NV-CoV-2-R. The new patent application covers the new technologies, compositions, formulations, processes, manufactured products, and methods of use, among other specifics. This patent application was filed on June 25, 2021, application number PCT/US2007/001607, entitled "Self-Assembling Amphiphilic Polymers As Anti-Covid-19 Agents". Its nominal expiry date would be 20 years, after filing and if issued, i.e. June 24, 2041, and could be extended in certain countries under regulatory extensions to as late as into the year 2043, providing a significant commercial runway.
Under the Agreement, NanoViricides has obtained a world-wide, exclusive, sub-licensable, license to use, promote, offer for sale, import, export, sell and distribute antiviral drugs that treat human Coronavirus infections using TheraCour's proprietary as well as patented technology and intellectual property, including the new patent application cited above. The discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed.
NanoViricides will not make any upfront cash payments to TheraCour and has agreed to the following milestone payments to TheraCour: 100,000 shares of the Company's Series A Convertible Preferred Stock, par value $0.001 per share (the "Series A Preferred Stock") upon the execution of the Agreement; 50,000 shares of Series A Preferred Stock after the grant of the approval of Licensee's Investigational New Drug (IND) Application, or its equivalent; cash payments of $1,500,000 after the initiation of Phase I clinical trials or its equivalent; $2,000,000 after the completion of Phase 1 Clinical Trials or its equivalent for at least one product within twelve (12) months from the date of the acceptance of the IND; $2,500,000 no later than six (6) months after the completion of Phase 2A Clinical Trials or its equivalent for at least one product within twenty (24) months from the date of the completion of Phase 1 or its equivalent; 100,000 shares of Series A Preferred Stock after the initiation of Phase 3 clinical trials or its equivalent; and, at TheraCour's option, $5,000,000 in cash or 500,000 shares of Series A Preferred Stock, no later than six (6) months after the completion of Phase 3 Clinical Trials or its equivalent for at least one product within thirty-six (36) months from the completion of Phase 2 Clinical Trials or its equivalent. In addition, the Company agreed to pay to TheraCour fifteen percent (15%) of net sales of licensed products and any income from sublicensed products, consistent with previous agreements. Under the Agreement, TheraCour retains the exclusive right to develop and manufacture the Licensed Products. The Agreement contemplates that the parties will enter into a separate Manufacturing and Supply Agreement for the commercial manufacture and supply of the drug products if and when NanoViricides intends to engage into commercialization of the drugs. The Agreement provides that the Manufacturing and Supply agreement would be on customary and reasonable terms, on a cost-plus basis, using a market rate based on then-current industry standards, and include customary backup manufacturing rights, as with prior agreements.
To assist in the analysis of the terms of the Agreement, NanoViricides commissioned research reports on Coronavirus drug market sizes for the Coronavirus antivirals field from an independent consulting agency, Nanotech Plus, LLC. Additionally, the Company obtained business analysis and valuation reports for potential licensing terms for a coronavirus drug from an independent consultant. NanoViricides was represented by McCarter & English, LLP while TheraCour was represented by DuaneMorris LLP.
The Series A Convertible Preferred Shares are only convertible upon a "change of control" of the Company as defined in its full specification, are non-transferrable and have no trading market. Each Series A share carries 9 votes, and is convertible only upon a change of control into 3.5 shares of the Company's common stock.
The Company's drug development business model was formed in May 2005 with a license to the patents and intellectual property held by TheraCour that enabled creation of drugs engineered specifically to combat viral diseases in humans. This exclusive license from TheraCour serves as a foundation for our intellectual property. The Company has a worldwide exclusive license to this technology for several drugs with specific targeting mechanisms for the treatment of a number of human viral diseases including coronaviruses, herpesviruses, VZV, HIV, Influenza, and others.
* PCT = Patent Cooperation Treaty. Enables global intellectual property protection.
About NanoViricides
NanoViricides, Inc. (the "Company")(https:?/www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. We are developing clinical candidates for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, the Company has several antiviral programs in various pre-clinical stages.
The Company is now working on tasks for completing an IND application for its COVID-19 drug candidates. The Company cannot project an exact date for filing an IND for this drug because of its dependence on a number of external collaborators and consultants. The Company is currently pursuing two separate drug candidates for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2 with remdesivir encapsulated in it. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.
The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: human Coronavirus infections, Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus and Ebola/Marburg viruses. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines.
View original content: https://www.prnewswire.com/news-releases/nanoviricides-completes-licensing-for-coronavirus-field-which-includes-current-covid-19-drug-development-301376002.html
SOURCE NanoViricides, Inc.
NEWS -- InvestorBrandNetwork (IBN) Announces Latest Episode of Stock2Me Podcast Featuring FuelPositive Corp. CEO Ian Clifford
LOS ANGELES, Sept. 14, 2021 (GLOBE NEWSWIRE) -- via InvestorWire — InvestorBrandNetwork (“IBN”), a multifaceted financial news and publishing company for private and public entities, is pleased to announce the release of the latest episode of The Stock2Me Podcast as part of its sustained effort to provide specialized content distribution via widespread syndication channels.
The Stock2Me Podcast features a fascinating array of companies and individuals, many of whom are actively revolutionizing age-old business practices within their respective markets. Stock2Me’s latest podcast features Ian Clifford, CEO of FuelPositive Corp. (TSX.V: NHHH) (OTCQB: NHHHF), a growth stage company focused on manufacturing, licensing, partnership and acquisition opportunities building upon various technological achievements.
Throughout the interview, Clifford discussed FuelPositive’s innovative carbon-free ammonia technology and its potential to change the energy landscape, both across Canada and around the world.
“We have purchased, back in April 2021, a cutting-edge technology that is designed to produce carbon-free ammonia, or carbon-free NH3 as it’s also known, in a proprietary, environmentally sound and economically viable process,” Clifford said. “This technology… allows for the production of ammonia in a scalable and modular fashion. That means that we can set up our systems to produce carbon-free ammonia where it’s needed and when it’s needed, which is a very, very significant departure from the way that ammonia is produced today… Ammonia today… is one of the most carbon-intense processes on the planet. Our system is entirely carbon-free.”
“We actually commissioned a report earlier in the year looking specifically at Canada’s excess generation of sustainable electricity to see how much energy there is available. We were delighted to see that there’s a tremendous excess of renewable electricity generation capability in Canada, and this situation exists all over the world,” he continued. “If we take excess generation in Canada, we utilize that sustainable electricity and run it through a FuelPositive system that then produces carbon-free ammonia onsite where it’s needed, you’ve got enough generation capacity to meet the demand… You could take existing cars and trucks and airplanes and tractors and convert those internal combustion vehicles to run on pure, carbon-free ammonia produced in a FuelPositive system… This technology could be available on a mass roll-out scale in the immediate future.”
“Our focus is very much now on determining and putting in place the best, highest profile demonstrations and programs possible early in 2022. To that end, we’re working with the Sussex Group, a government relations group based in Ottawa and Toronto,” Clifford explained. “Sussex is introducing us to all of the key stakeholders within the Canadian government, both federally and provincially, to ensure that we’ve got the best and highest visibility for our demonstration programs early next year.”
Join InvestorBrandNetwork’s Stuart Smith and Ian Clifford, CEO of FuelPositive Corp. (TSX.V: NHHH) (OTCQB: NHHHF), as they explore the incredible versatility of the company’s carbon-free ammonia technology, the initial markets FuelPositive intends to target with its demonstrations and the potential role of ammonia in shaping a carbon-free future.
To hear the whole podcast and subscribe for future episodes, visit https://podcast.stock2me.com.
The latest installment of The Stock2Me Podcast continues to reinforce InvestorBrandNetwork’s commitment to the expansion of its robust network of brands, client partners, followers and the growing IBN Podcast Series. For more than 15 years, IBN has leveraged this commitment to provide unparalleled distribution and corporate messaging solutions to 500+ public and private companies.
To learn more about IBN’s achievements and milestones via a visual timeline, visit https://IBN.fm/TimeLine
About FuelPositive Corp.
FuelPositive Corp. is a Canadian growth-stage technology company committed to providing commercially viable and sustainable, “cradle to cradle”, clean energy solutions, including carbon-free ammonia (NH3), for use across a broad spectrum of industries and applications. By focusing on technologies that are clean, economically advantageous/realizable and that leverage existing infrastructure, the company aims to change the course of climate change through practical solutions that can be implemented now. For more information, visit the company’s website at https://www.FuelPositive.com
About InvestorBrandNetwork
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Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company's SEC filings. These risks and uncertainties could cause the company's actual results to differ materially from those indicated in the forward-looking statements.
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NEWS -- Opregen® Data Update Will Be Featured at 54th Annual Retina Society Meeting in Podium Presentation by Christopher D. Riemann, M.D.
CARLSBAD, Calif., September 13, 2021--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported today that updated interim results from a Phase 1/2a study of its lead product candidate, OpRegen®, a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), will be featured in a podium presentation at the 54th Annual Scientific Meeting of the Retina Society, to be held at the Ritz-Carlton Hotel in Chicago, IL (September 29 – October 2, 2021). The presentation, "Phase 1/2a Clinical Trial of Transplanted Allogeneic Retinal Pigmented Epithelium (RPE, OpRegen) Cells in Advanced Dry Age-Related Macular Degeneration (AMD): Interim Results," will be presented on September 30, 2021 at 9:52 am EDT by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine.
Lineage also intends to present updated interim results from the Phase 1/2a study later this month, which will include a minimum of 9 months of follow-up in all 24 patients treated with OpRegen, including all 12 patients treated in Cohort 4, which had better baseline vision and smaller areas of GA at baseline than earlier cohorts.
The Retina Society was founded in 1968 exclusively for educational and scientific purposes concerning the diagnosis, care and treatment of diseases and injuries to the retina. For more information on the Retina Society or its annual scientific meeting, please visit https://www.retinasociety.org/ or follow the association on Twitter @RetinaSociety.
About OpRegen
OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with geographic atrophy (GA). The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with Best Corrected Visual Acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of Lineage Cell Therapeutics, Inc.
About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch's membrane and the retinal pigmented epithelium (RPE), known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no U.S. Food and Drug Administration, or European Medicines Agency, approved treatment options available for patients with atrophic AMD.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of subacute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210913005252/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
Gitanjali Jain Ogawa
(mailto://Gogawa@soleburytrout.com)
(646) 378-2949
Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242
NEWS -- CytoSorbents Commemorates World Sepsis Day and Sepsis Awareness Month with Key Sepsis-Related Events, Sponsorships and Studies
MONMOUTH JUNCTION, N.J., Sept. 13, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions, such as sepsis, in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces key sepsis-related events, sponsorships and studies in conjunction with World Sepsis Day today and Sepsis Awareness Month (September).
Sepsis arises when the body's immune response to a serious infection injures its own tissues and organs. Sepsis is often associated with excessive inflammation driven by a cytokine storm. This in turn may lead to serious complications such as shock, failure of vital organs, and death – especially if not recognized early and treated promptly. Sepsis is the final common pathway to death from most infectious diseases worldwide, including viruses such as SARS-CoV-2, the virus that causes COVID-19. In aggregate, one in five deaths worldwide continue to be associated with sepsis, despite the broad use of antibiotics and other medications. CytoSorbents' flagship product CytoSorb® has been used extensively in patients experiencing sepsis or septic shock to reduce cytokine storm and inflammation through blood purification, with the goals of reducing the severity and complications of sepsis, while helping to stabilize the patient.
Dr. Christian Steiner, Executive Vice President of Sales and Marketing of CytoSorbents, stated, "Septic shock, or a life-threatening persistent drop in blood pressure, confers a high risk of mortality in sepsis. In international clinical guidelines, its treatment is key to sepsis survival. Historically, however, treatment options have been predominantly supportive. CytoSorb has demonstrated the ability to reverse septic shock in multiple published studies. We now look to extend our understanding of how best to use CytoSorb to treat refractory septic shock – one of the deadliest forms of sepsis - in the upcoming company-sponsored, randomized, controlled PROCYSS trial in Germany. We expect the trial to start shortly, with the first patients enrolled before year-end."
Last week, CytoSorbents proudly sponsored the 10th Annual Sepsis Update 2021 Congress, from September 8-10, 2021, hosted by the German Sepsis Society in Weimar, Germany. As in years past, CytoSorbents once again was the corporate sponsor of the prestigious Roger Bone Prize for excellence in clinical sepsis research. This year's prize was awarded to Dr. Wolfgang Bauer from Charité University Medical Hospital in Berlin, Germany during the Opening Ceremony of the Congress for his work in comprehensive RNA diagnostics for viral and bacterial infections.
Dr. Steiner added, "CytoSorbents has long funded and supported sepsis research and education, so it was a personal honor to present the Roger Bone Award to Dr. Bauer from Charité for his outstanding research and accomplishments in the sepsis field. We believe it is important to recognize and support up-and-coming sepsis researchers who will one day help us end the sepsis scourge."
The Company also hosted a lunch symposium at the Sepsis Update 2021 Congress entitled "Hemoadsorption with CytoSorb in Sepsis and COVID-19 Patients – an Update" on Friday September 10, 2021.
Chair:
NEWS -- Plus Therapeutics Announces the Appointment of Industry Veteran, Norman LaFrance, M.D., as the Company’s Chief Medical Officer
AUSTIN, Texas, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced the appointment of Norman LaFrance, M.D. to the position of Chief Medical Officer and Senior Vice President.
“We are delighted to have Dr. LaFrance onboard as he brings several decades of highly relevant clinical, regulatory and commercial expertise to the Plus Therapeutics management team,” stated Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “His proven track record in radiotherapeutics and drug development coupled with his commercial experience will be invaluable as we expand our pipeline, move key programs to late stage clinical development and best position the company for long-term regulatory and commercial success.”
Dr. LaFrance’s appointment begins on or around December 8, 2021 and he joins the Company with nearly 40 years of experience as a nuclear medicine physician and as an executive in the pharmaceutical and healthcare industries. Dr. LaFrance has a particular expertise in radiotherapeutic drug research and development as well as commercialization of molecular imaging, diagnostic and therapeutic products. He was most recently Chief Medical Officer, Senior Vice President, at Jubilant Pharma Ltd, responsible for all Pharma Medical & Regulatory Affairs activities.
“I am excited to join a company which reflects my passion to make an impact on patients with significant unmet medical needs,” said Norman LaFrance, M.D. “From an industry perspective, it is clear that Plus Therapeutics’ focus on radiotherapeutics positions it firmly for long-term growth, and I am excited to lead development and expansion of its promising pipeline.”
Prior to Jubilant Pharma, Ltd., Dr. LaFrance served as Global Chief Medical Officer at IBA Molecular from 2010 to 2012, and as Senior Vice President, Clinical Development and Chief Medical Officer at Molecular Insight Pharmaceuticals from 2007 to 2010. Prior to industry, Dr. LaFrance practiced medicine and held academic faculty appointments at Johns Hopkins University School of Medicine in the departments of medicine and radiology and the Department of Radiological Sciences in the John Hopkins School of Hygiene and Public Health. He is Double Board Certified with Fellowship status both in internal medicine and nuclear medicine, maintains active medical licensure in the U.S. along with active, professional society membership.
Dr. LaFrance received his bachelor of science and master of engineering degrees in nuclear engineering and science from Rensselaer Polytechnic Institute, and his medial degree from the University of Arizona, College of Medicine, Tucson.
About Plus Therapeutics, Inc.
Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.
Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Corporate Update: FuelPositive Prototype Development Milestones Set and Met
TORONTO, Sept. 13, 2021 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (“FuelPositive” or the “Company”) is issuing the following update to share the status of the company and its various initiatives. FuelPositive is a Canadian growth-stage technology company committed to providing commercially viable and sustainable, “cradle to cradle”, clean energy solutions to combat climate change. Its lead technology is a system for producing carbon-free ammonia (NH3), for use across a broad spectrum of industries and applications.
“Having received extensive interest from investors and potential partners since our last corporate update on July 15, we felt it would be helpful to share how we are progressing, particularly regarding the building of our Phase 2 Hydrogen-Ammonia Synthesizer commercial prototype systems,” said Ian Clifford, FuelPositive CEO and Board Chair. “We also wanted to let people know about our participation in the H.C. Wainwright 23rd Annual Global Investment Conference which provides an opportunity to see our most recent corporate presentation.”
The H.C. Wainwright 23rd Annual Global Investment Conference is taking place virtually from September 13 to 15, 2021. FuelPositive’s corporate presentation will be available to registered conference attendees for on-demand viewing beginning at 7 a.m. EST on September 13, 2021. FuelPositive CEO and Board Chair Ian Clifford will be available for one-on-one meetings throughout the week of September 13, 2021. (Contact information is below)
Phase 2 Production Systems Status
The successful building of the prototype systems will confirm the broad application potential for the Company’s carbon-free NH3 technology. The modular and transportable systems, which are being built to shipping container configurations, will be adaptable to multiple applications. Production of the demonstration prototype systems is scheduled to be completed by the end of 2021, with high-visibility pilot projects being planned for 2022.
Since announcing a partnership with National Compressed Air (NCA) in May 2021, the Company is executing against a detailed production plan in order to complete the building of the prototypes by the end of 2021.
Milestones met to date include:
Here it is!!!
Video River Networks
@NIHKEV
Great news. Finalizing details on the first shipment of cars that will available in the showroom. More information coming next week. $NIHK $DRNG $GMPW #ElectricVehicles #EV #FuturelooksBright
I am predicting by mid-2022 a market cap of 200 million for fuel positive , and that is still dirt cheap for this company.
NEWS -- CytoSorbents Announces Filing of an Investigational Device Exemption (IDE) for the U.S. Clinical Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR™ Antithrombotic Removal System During Urgent Cardiothoracic Surgery
MONMOUTH JUNCTION, N.J., Sept. 10, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the filing of an Investigational Device Exemption (IDE) application to gain FDA approval to conduct the clinical study, "Safe and Timely Antithrombotic Removal – Direct Oral Anticoagulants (STAR-D)," in the United States to support FDA marketing approval. This is being performed under the previously announced FDA Breakthrough Device Designation granted to DrugSorb-ATR® for the removal of apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic surgery.
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated "The investigational plan set forth in this IDE filing comes approximately one month after the FDA granted Breakthrough Designation for this application, demonstrating the operational efficiencies of our clinical and regulatory teams and the leveraged synergies with the previously approved and currently active U.S. STAR-T pivotal trial to remove ticagrelor during urgent cardiothoracic surgery. We expect discussions with FDA on the current IDE application to conclude in the fourth quarter of 2021 and if approved, plan to commence study initiation activities for this second DrugSorb-ATR trial immediately thereafter. We plan to provide more details on the STAR-D trial, designed to support U.S. FDA marketing approval for this additional application, in the near future."
In August 2021, the FDA granted CytoSorbents Breakthrough Device Designation to remove the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban to reduce the risk of serious bleeding during urgent cardiothoracic surgery, recognizing this major unmet medical need. Apixaban (Eliquis®, Bristol Myers Squibb/Pfizer) and rivaroxaban (Xarelto®, Jansen/Bayer) are two of the most commonly prescribed anticoagulants worldwide, including more than 5 million patients1 annually in the United States who are chronically on these medications to reduce the risk of deadly blood clots due to atrial fibrillation, prior history of heart attack or stroke, deep vein thrombosis, pulmonary embolism, and peripheral artery disease. We expect the number of patients prescribed these drugs to continue to climb based on the superior performance of these agents compared to older alternatives, underlying demographic trends in the aging baby boomer population, improved disease detection rates, and other factors. When patients on various "blood thinners", like apixaban or rivaroxaban, require urgent cardiothoracic surgery, the risk of serious or life-threatening bleeding and complications is very high. Based on our estimates, at least 1% of patients in the U.S. on apixaban or rivaroxaban may require urgent cardiothoracic surgery on an annual basis. Today there are no approved or cleared alternatives in the U.S. to reduce bleeding risks during cardiothoracic surgery caused by direct oral anticoagulants. With the appropriate U.S. marketing approvals for removal of ticagrelor and the two leading DOACs during cardiothoracic surgery, DrugSorb-ATR has the potential to address these major unmet medical needs, while targeting an estimated U.S. total addressable market of one billion dollars.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 143,000 CytoSorb devices have been delivered to date. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, rivaroxaban and apixaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and www.https://cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, anticipated future results and performance, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 9, 2021, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
mailto://tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@runbensteinpr.com
1 Agency for Healthcare Research and Quality. Number of people with purchase in thousands by prescribed drug, United States, 1996-2018. Medical Expenditure Panel Survey. Generated interactively May 27, 2021. CytoSorbents estimates.
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