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FuelPositive Corporation's Ian Clifford is Interviewed by Ashton Addison of InvestmentPitch Media
https://www.newsfilecorp.com/release/86869
NEWS -- FuelPositive Files Patent Application for Clean Hydrogen and Ammonia Technology
TORONTO, June 08, 2021 (GLOBE NEWSWIRE) -- Today, the FuelPositive Corporation (TSX.V: NHHH) (OTC: NHHHF) (“FuelPositive” or the “Company”) is pleased to announce that it has filed for patent protection for the Company’s “Modular Transportable Clean Hydrogen-Ammonia Maker” with the United States Patent and Trademark Office (U.S. provisional patent application number: 63197884).
“Our carbon-free ammonia (NH3) technology will offer tremendous value by using less energy than incumbent technologies and will reduce processing costs through the reduction of operating pressure and temperatures,” said Ian Clifford, CEO of FuelPositive. “This milestone for FuelPositive further reinforces the potential for the global implementation of our technology, and we are working rapidly toward commercialization, with Phase 2 commercial demonstration systems well on their way to being realized.”
About FuelPositive
FuelPositive is a Canadian-based growth stage company committed to providing commercially viable and sustainable energy solutions, including clean ammonia (NH3), for use across a broad spectrum of industries, systems and applications.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
All statements, other than statements of historical fact, contained in this press release including, but not limited to, (i) generally, or the “About FuelPositive” paragraph, which essentially describes the Company’s outlook and objectives, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.
For Media or Investor enquiries, please contact:
Mr. Ian Clifford
Chief Executive Officer
mailto://investors@fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
The oil killer Fuel Positive!!!
NEWS -- Kintara Therapeutics Set to Join Russell Microcap® Index
SAN DIEGO, June 7, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced Kintara's addition to the Russell MicrocapÒ Index. This milestone will take place at the conclusion of the 2021 Russell Indexes' annual reconstitution, effective after the U.S. market opens on June 28, 2021 according to a preliminary list of additions posted June 4, 2021.
"We are delighted for Kintara to have been added to the FTSE Russell Microcap® Index, which will help increase investor exposure to our Company's mission of developing novel cancer therapies for patients with unmet medical needs," said Saiid Zarrabian, CEO of Kintara. "We look forward to the opportunity to expand awareness of our late-stage oncology pipeline of which our lead product, VAL-083, is currently being tested in GCAR's GBM AGILE registrational study for all three GBM patient subtypes of newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent GBM."
Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell Indexes primarily by objective, market-capitalization rankings, and style attributes.
Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's U.S. Indexes. Russell Indexes are part of FTSE Russell, a leading global index provider.
ABOUT KINTARA
Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs.
Kintara is developing two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).
VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.
Kintara is also advancing its proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC, who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.
SAFE HARBOR STATEMENT
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company's clinical trials and the GBM AGILE study. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended June 30, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
CONTACTS:
Investors:
CORE IR
516-222-2560
mailto://ir@coreir.com
Media:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
mailto://julesa@coreir.com
View original content to download multimedia: http://www.prnewswire.com/news-releases/kintara-therapeutics-set-to-join-russell-microcap-index-301306592.html
SOURCE Kintara Therapeutics
NEWS -- Provectus Biopharmaceuticals Announces Presentation of Full Study Data from Metastatic Neuroendocrine Cancer Phase 1 Trial of PV-10® at American Society of Clinical Oncology (ASCO) 2021 Annual Meeting
KNOXVILLE, TN, June 04, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that preliminary full study data from the Company’s Phase 1 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) (https://clinicaltrials.gov/ct2/show/NCT02693067) is be presented at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, held June 4-8 online.
Highlights from the mNET Presentation at ASCO 2021:
NEWS -- Heat Biologics to Showcase Favorable Survival Data of HS-110 in Previously Treated Non-Small Cell Lung Cancer Patients at 2021 American Society of Clinical Oncology Annual Meeting
Survival benefit observed in two treatment settings of previously treated non-small lung cancer patients
DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) -- 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 Dr. Roger B. Cohen, MD, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, presented an overview of the latest HS-110 data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting which is being held from June 4-8, 2021. This poster presentation can be viewed on Heat Biologics' website at: https://www.heatbio.com/product-pipeline/scientific-publications. The ASCO Annual Meeting is the world’s largest oncology conference showcasing the latest advancements in cancer research.
HS-110, in combination with a checkpoint inhibitor (CPI), is a potentially transformational agent to improve survival benefit for patients with non-small cell lung cancer (NSCLC). This is a first-in-class, allogeneic, off-the shelf cell-based therapy developed by Heat leveraging its proprietary gp96 platform. At this year’s ASCO meeting, the Company is pleased to report the latest data of HS-110 in combination with OPDIVO® (nivolumab) in two distinct treatment settings in a total of 115 previously treated patients with NSCLC:
Isopet trademark updated https://twitter.com/radiogel?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor
2.5 billion shares out and lots of sells , sell on news what a momo.
NEWS -- Innovation Pharma Completes Enrollment in Phase 2 Clinical Trial for COVID-19
WAKEFIELD, Mass., June 03, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announced today that it has achieved full patient enrollment in its randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897). Innovation Pharmaceuticals is developing Brilacidin for treatment of COVID-19 under U.S. FDA Fast Track designation.
Complete trial enrollment comprised 120 dosed patients recruited across multiple sites. Final data collection for the last patient enrolled in the study is expected to occur in early August (Study Day 60), which will then be followed by the process of unblinding study data and the reporting of topline study results.
“We are pleased to have reached this company milestone and particularly thank all of the participating investigator sites and patients, in addition to many others involved in supporting the completion of study enrollment, especially given the challenges brought on by the pandemic,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Encouraged by extensive laboratory-based Brilacidin antiviral research focused on coronaviruses, and building on previous pre-clinical and clinical results demonstrating a robust Brilacidin therapeutic profile, we prioritized the development of Brilacidin as a novel antiviral. To us, this is much more than a COVID-19 study. Our goal is to develop a broad spectrum antiviral not just to help contain today’s pandemic, but also one that could be deployed against other infectious and deadly viruses that inevitably will follow. As such, we eagerly look forward to our Brilacidin COVID-19 trial readout.”
Based on pre-clinical studies, Brilacidin is exhibiting an ability to directly disrupt viral integrity, a potent virucidal property, enabling it to be unaffected by mutations that give rise to variants—a beneficial trait differentiating Brilacidin from other antivirals.
About Brilacidin and COVID-19
Brilacidin is the only non-peptidic defensin-mimetic drug candidate currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19. Additionally, Brilacidin has shown potent and consistent inhibition in vitro against coronaviruses, alphaviruses and bunyaviruses (with lab testing against other viruses also underway), supporting Brilacidin’s potential to be developed as a broad spectrum antiviral. The annual global antiviral drug market is estimated to reach $44 billion by 2026.
A peer-reviewed article in Viruses supporting Brilacidin’s COVID-19 treatment potential can be accessed at the link below.
NEWS -- Kintara Therapeutics Enrolls Final Patient in Phase 2 Clinical Trial of VAL-083 for Adjuvant Treatment of Brain Tumors
SAN DIEGO, June 3, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced it has enrolled the final patient in the adjuvant arm of its ongoing Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson). The adjuvant arm of the study investigates newly-diagnosed patients suffering from glioblastoma multiforme (GBM) receiving VAL-083 in place of standard of care temozolomide (TMZ) as adjuvant therapy following surgery and chemoradiation TMZ. The trial was designed to enroll up to 36 patients to determine whether treatment with VAL-083 improves overall survival.
The Phase 2 trial is an open-label, two-arm, biomarker-driven study testing VAL-083 in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. Efficacy is being measured based on overall survival and progression-free survival. In February 2021, the Company announced the trial's second arm (recurrent GBM) enrolled its final patient.
"Enrolling the final patient in the adjuvant arm of the Phase 2 study at MD Anderson is yet another important milestone for the Company as we continue to advance VAL-083 in multiple settings including the GCAR sponsored GBM AGILE study where we have already initiated patient recruitment at 15 sites as the only therapeutic agent currently being evaluated in this adaptive design registration study for all three GBM patient subtypes; newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent," commented Saiid Zarrabian, Kintara's Chief Executive Officer.
VAL-083 is a small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.
About Kintara
Located in San Diego, California, Kintara (NASDAQ: KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).
VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the NCI. Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.
REM-001 is a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.
For more information, please visit https://www.kintara.com or follow us on Twitter at @Kintara_Thera, Facebook and Linkedin.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company's clinical trials and the GBM AGILE study. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended June 30, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
CONTACTS
Investors
CORE IR
516-222-2560
mailto://ir@coreir.com
Media
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
mailto://julesa@coreir.com
View original content to download multimedia: http://www.prnewswire.com/news-releases/kintara-therapeutics-enrolls-final-patient-in-phase-2-clinical-trial-of-val-083-for-adjuvant-treatment-of-brain-tumors-301304998.html
SOURCE Kintara Therapeutics
NEWS -- Lineage Cell Therapeutics to Host Webinar With Therapeutic Area Experts to Discuss Retinal Tissue Restoration Observed in Dry AMD Patients Treated With OpRegen®
Webinar Scheduled for June 10, 2021 at 4pm Eastern Time / 1pm Pacific Time
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that it plans to host a webinar featuring external therapeutic area experts in age-related macular degeneration (AMD), on June 10, 2021 at 4pm ET /1pm PT. Lineage recently reported that restoration of retinal tissue has been observed in three patients enrolled in the Company’s Phase 1/2a study of its lead product candidate, OpRegen, an allogeneic retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of AMD with geographic atrophy (GA), or dry (atrophic) AMD. These new findings occurred in three of the four better baseline vision (Cohort 4) patients for whom surgeons successfully covered the majority of the area of atrophy with a suspension of OpRegen RPE cells. Outer retinal layer restoration, which was observed using high-resolution Optical Coherence Tomography (OCT), was evidenced by the presence of new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment. These findings suggest integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of any of these cells. These effects were most prominent in the transitional areas around the primary area of GA. The webinar will feature therapeutic area experts who will discuss these findings in detail, including a review of anatomical improvements, functional activity, and additional results of treatment with OpRegen. Interested parties can access the webinar on the Events and Presentations section of Lineage’s website.
Therapeutic Area Experts, External Reviewers & Contributors
Eyal Banin, M.D., Ph.D., Director, Center for Retinal and Macular Degenerations (CRMD), Department of Ophthalmology, Hadassah-Hebrew University Medical Center.
Dr. Banin is a graduate of the Hebrew University-Hadassah School of Medicine, holds a Ph.D. in Neurobiology from the Hebrew University, and completed his ophthalmology residency at Hadassah Medical Center. Following a post-doctoral and medical retina fellowship at the University of Pennsylvania’s Scheie Eye Institute in Philadelphia, he was appointed head of the Medical Retina Service and the CRMD at Hadassah. His main clinical and research focus is in the field of retinal and macular degenerations, including the development and application of novel cell- and gene-based therapies for these diseases. The recipient of many research grants from Israeli and foreign institutions, Dr. Banin has authored and published over 150 peer-reviewed articles in leading medical and scientific journals.
Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula, Director and Principal Investigator, Barcelona Macula Foundation: Research for Vision.
Dr. Monés is an ophthalmologist, macula and vitreoretinal specialist, and macular and retinal degeneration researcher. Dr. Monés earned his medical degree at the University of Barcelona and subsequently specialized in ophthalmology at Barraquer Ophthalmology Centre. He completed his retinal specialist training at the Massachusetts Eye and Ear Infirmary at Harvard University, and at Hospital San José, Monterrey Institute of Technology and Higher Education. He earned his PhD degree in Medicine and Surgery at the University of Barcelona. Dr Monés is dedicated to fighting blindness by supporting and conducting research in retinal disease. For the last 15 years he has been one of the foremost researchers involved in clinical trials for the treatment of age-related macular degeneration. He is currently conducting Phase I, II and III clinical trials. His work has been widely published in scientific journals and he has given more than 200 presentations at international congresses. He is a member of 12 scientific societies.
Brandon Lujan, M.D., Associate Professor of Ophthalmology, School of Medicine, OHSU Casey Eye Institute.
Dr. Lujan is a medical retina specialist, scientist, and Director of the Casey Reading Center. Dr. Lujan’s area of expertise is Optical Coherence Tomography (OCT) retinal imaging, and he is the first-named inventor and co-developer of Directional OCT, a technique and device capable of creating optical contrast in photoreceptors. Dr. Lujan has published and spoken internationally on diagnosis and management of macular diseases and has brought that expertise to bear on clinical trials. He is the creator of OCTMD, an educational resource focused on the present and future of OCT. Dr. Lujan is a member of the Macula Society, Retina Society, the Association for Research and Vision in Ophthalmology, and the American Society of Retina Specialists.
Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine.
In collaboration with the other retinal surgeons at CEI, Dr. Riemann is a principal investigator or co-investigator for many Phase II and Phase III clinical trials. He specializes in medical and surgical vitreoretinal diseases including diabetic retinopathy, macular degeneration, retinal detachment, retinopathy of prematurity, vascular diseases of the retina, uveitis, histoplasmosis, complications of anterior segment surgery, endoscopic posterior segment surgery, and ocular trauma. Dr. Riemann is a member of the American Society of Retina Specialists, American Academy of Ophthalmology, Ohio State Medical Association, Cincinnati Academy of Medicine, Cincinnati Ophthalmology Society, and the Association for Research in Vision and Ophthalmology. His original research in the fields of Ophthalmology, Cardiology, and Endocrinology has been published in international peer reviewed scientific journals and has been presented at national scientific meetings. Dr. Riemann has several patents for innovative surgical technologies and enjoys sharing his passion for the blend of engineering and medicine.
Michael S. Ip, M.D., Professor, Department of Ophthalmology at the David Geffen School of Medicine at the University of California - Los Angeles.
Dr. Ip is a member of the Doheny Eye Institute and currently serves as the Medical Director of the Doheny Image Reading Center. His research focuses on the design and conduct of clinical trials investigating treatments for diabetic retinopathy, AMD, and retinal venous occlusive disease and other retinal diseases. Dr. Ip has assisted with the collection, analysis, and dissemination of important primary and secondary outcomes in ophthalmic clinical trials. In 2003, Dr. Ip was selected to serve as the national protocol chair for the clinical trial conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema (protocol B). This was a landmark study and changed practice patterns in the field of ophthalmology. In 2003, his independent and investigator-initiated research group received a U-10 cooperative agreement award from the National Eye Institute, National Institutes of Health to conduct the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study. This was a multicenter, randomized, NIH-defined phase 3 trial which led to over 15 publications in the peer-reviewed literature and provided much needed Level 1 evidence to guide our management of retinal venous occlusive disease. In 2013, this group received funding from the NEI to conduct the SCORE2 Study. The SCORE2 Study is an NIH-defined phase 3 clinical trial designed to evaluate the comparative efficacy and safety of bevacizumab versus aflibercept for the treatment of macular edema secondary to central retinal vein occlusion. It has been designed to answer several questions of significant public health importance. Currently, this study group has extended the SCORE2 follow up phase to evaluate long-term safety and efficacy outcomes in central retinal vein occlusion.
Allen C. Ho, M.D. FACS, Wills Eye Hospital Attending Surgeon and Director of Retina Research, Professor of Ophthalmology, Thomas Jefferson University.
Dr. Ho maintains special interests in macular diseases, diabetic retinopathy, surgical retinal diseases and clinical trials investigating new treatments for vitreoretinal diseases including gene and cell therapies and new surgical drug delivery devices and techniques. His experience includes collaborative translational and clinical trial clinical research with expertise in study design, methodological testing, data analyses, surgical instrumentation and procedure development, execution and communication of these studies and their study results. He is the current President of The Retina Society and serves on its Executive Committee. Dr. Ho has been Study Chair, Steering Committee Member or Principal Investigator of over 50 clinical trials. Dr. Ho has served on the US FDA Ophthalmic Device Panel, American Academy of Ophthalmology (AAO) Ophthalmic Retina Technology Assessment Committee, AAO Retina Measures Group, AAO IRIS Registry Committee and is past Chair of the AAO Retina Subspecialty Days and Vail Vitrectomy meetings. Through the Wills Eye Hospital Retina Fellowship he has mentored over 60 retina fellows and international research trainees. Dr. Ho has authored over 200 peer reviewed publications and several textbooks and is Editor-in-Chief of Current Opinion in Ophthalmology and Chief Medical Editor of Retina Today.
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 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 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 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/20210603005234/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 -- Kintara Therapeutics to Present at the LD Micro Virtual Invitational Conference on June 9, 2021
SAN DIEGO, June 2, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced today that Chief Executive Officer Saiid Zarrabian will present a corporate overview at the three-day LD Micro Virtual Invitational Conference being held on June 8 – 10, 2021.
Mr. Zarrabian will deliver his corporate presentation on June 9 at 2:30 pm ET, Track 1.
Register to watch the presentation here: https://ldmicrojune2021.mysequire.com/.
Investors interested in scheduling a meeting with management should contact mailto://assistant@ldmicro.com.
About Kintara
Located in San Diego, California, Kintara (Nasdaq: KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).
VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.
REM-001 is a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.
For more information, please visit https://www.kintara.com or follow us on Twitter at @Kintara_Thera, Facebook and Linkedin.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company's clinical trials and the GBM AGILE study. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended June 30, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
CONTACTS
Investors
CORE IR
516-222-2560
mailto://ir@coreir.com
Media
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
mailto://julesa@coreir.com
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SOURCE Kintara Therapeutics
NEWS -- CytoSorbents Appoints Terri Anne Powers, IRC as Vice President of Investor Relations and Corporate Communications
Terri Anne Powers, IRC, experienced financial and communications professional, to strengthen and expand relationships with the investment and broader stakeholder community by building best-in-class investor relations and corporate communications function
MONMOUTH JUNCTION, N.J., June 1, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care therapy leader commercializing its CytoSorb® blood purification technology to treat deadly conditions in critically ill and cardiac surgery patients around the world, announces the appointment of Terri Anne Powers, MBA, IRC, as Vice President of Investor Relations and Corporate Communications effective today.
Ms. Powers was most recently Vice President of Investor Relations at publicly-traded Diplomat Pharmacy, Inc., the largest independent provider of specialty pharmacy services in the United States, prior to its acquisition in 2020. At Diplomat, she established the in-house investor relations function and supported overall corporate communications. Prior to Diplomat, Ms. Powers spent nine years as Director of North American Investor Relations for France-based Veolia Environnement, a publicly-traded global water, waste, and energy services leader.
Powers has more than 15 years of experience in the healthcare industry. In addition to her time at Diplomat, Powers spent seven years as an associate sell side analyst covering healthcare distribution and services equities at Robert W. Baird and Prudential Securities. Ms. Powers started her career as a chemist conducting research and development in the pharmaceutical industry at the G.D. Searle unit of Monsanto, where she also held other roles in preclinical drug development and as a global market research analyst.
Ms. Powers received her M.B.A. in finance and strategic management from the University of Chicago Booth School of Business. She received her B.S. in chemistry from Alma College, where she graduated with summa cum laude and Phi Beta Kappa honors. Ms. Powers is also an active member of NIRI, the National Investor Relations Institute, and holds the Investor Relations Charter (IRC) credential.
Ms. Powers stated, "I am thrilled to join CytoSorbents at such an exciting time and look forward to working with the leadership team and Board of Directors to increase the Company's visibility in the capital markets and broader stakeholder community. A key focus will be to foster an open dialog with all current and prospective investors, while systematically cultivating and expanding the shareholder base to a broader set of investors, both domestic and international. I believe that CytoSorbents' mission to save lives through blood purification is such a compelling story that it needs to be heard more broadly."
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "We are delighted to welcome Terri Anne as Vice President of Investor Relations and Corporate Communications, bringing this position in-house for the first time. Terri Anne has established a reputation in the healthcare industry as a smart, credible, articulate, and responsive IR professional and analyst, with strong relationships among many major investors. The dedicated focus and skill set she brings to CytoSorbents is perfectly timed as we communicate our exciting growth story and path to potential U.S. FDA approval to investors, our business partners, and the medical community worldwide."
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in 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" that may result in massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death can be extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 131,000 human treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma), and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and 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 products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.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, 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.
CytoSorbents Investor Relations Contact:
Terri Anne Powers
Vice President of Investor Relations and Corporate Communications
732-482-9984
mailto://tpowers@cytosorbents.com
Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3055
mailto://ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation
NEWS -- Lineage Cell Therapeutics Reports Additional Cases of Retinal Tissue Restoration in Dry AMD Patients Treated With OpRegen® RPE Cells
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that restoration of retinal tissue was observed in two additional patients enrolled in the Company’s Phase 1/2a study of its lead product candidate, OpRegen. OpRegen is an allogeneic retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of age-related macular degeneration (AMD) with geographic atrophy (GA), or dry (atrophic) AMD. These new findings occurred in two of the three Cohort 4 patients treated in November of 2020, where surgeons successfully covered the majority of the area of atrophy with a suspension of OpRegen cells. Outer retinal layer restoration, which was observed using clinical high-resolution Optical Coherence Tomography (OCT), was evidenced by the presence of new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment. These findings suggest integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of any of these cells. These effects were most prominent in the transitional areas around the primary area of GA. In addition to positive anatomical changes, all three patients’ visual acuity increased above baseline levels within 6 months post-transplant. The totality of these findings supports the view that atrophic AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable.
In connection with these findings, Lineage has filed a Patent Cooperation Treaty (PCT) patent application which describes restoration of the anatomy and/or functionality of diseased retinas. The application is based on clinical trial data demonstrating, for the first time, administration of RPE cells to an atrophic retina restores structure and function to one or more retinal layers. Allowed claims of a national patent application based on the PCT application would have an estimated expiration date of at least May 24, 2041.
"After reporting the first case of retinal restoration last year, it is extremely exciting for me to see retinal restoration replicated in additional OpRegen-treated patients. Confirmation of restoration was performed by independent experts using multimodality imaging techniques and these new cases reinforce earlier findings that treatment with OpRegen can save dysfunctional photoreceptors and replace RPE cells in areas of geographic atrophy, which could provide a remarkable treatment opportunity for this patient population," stated Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula and Director, Principal Investigator and Founder, Barcelona Macula Foundation. "It has long been hypothesized that in atrophic AMD patients, cells in the transition areas at the boundaries of the GA are dysfunctional and dying, but not completely lost. These unprecedented findings provide further evidence that the addition of new RPE cells may restore the microenvironment of the surrounding tissue and contribute to the survival and function of existing cells that otherwise, if left untreated, would inevitably progress to further expansion of the atrophic region."
"To our knowledge, these three patients represent the only examples of an experimental treatment for dry AMD demonstrating a reduction, rather than attenuating further expansion, of an area of atrophy in humans," stated Brian M. Culley, Lineage CEO. "Now that these findings of retinal restoration have been confirmed in multiple patients over clinically meaningful time periods, we believe we are in a position to pioneer a new paradigm for how we and others evaluate and treat atrophic AMD. Notably, 75% of patients who received broad coverage of OpRegen across the area of GA exhibited evidence of restoration, indicating that clinical benefits may be improved by a more central and complete placement of OpRegen cells across the atrophic area. Importantly, in addition to thickening of the outer nuclear layers and restoration of retinal structures in these patients, we also have observed durable improvements in visual acuity. Additional evidence collected recently supports our belief that treatment with OpRegen can provide patients not only with improvements in the anatomy and the structure of their retina and visual acuity, but also enhance quality of life. We will discuss these new findings with our advisors in the coming weeks and months to assess implications for the clinical development and regulatory approval pathways for OpRegen. We believe these findings represent a significant advancement in the field of cell therapy, in which the directed differentiation and transplant of specific cell types to treat severe diseases and conditions may generate outcomes which have remained out of the reach of traditional molecular approaches."
The loss of RPE cells over time creates progressively larger areas of atrophy in the adult retina, leading to impaired vision or complete blindness, a condition known as atrophic AMD. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which led to a presumption that progression of GA may someday be slowed or halted but could not be reversed. The unique findings from the ongoing OpRegen clinical study support a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. Notably, in the two additional Cohort 4 patients evidencing retinal restoration, in peripheral areas of incomplete RPE and outer retinal atrophy (iRORA), away from the primary atrophic lesion, there were examples of complete resolution following OpRegen transplant in some of the iRORA lesions. Additionally, in some areas of complete RPE and outer retinal atrophy (cRORA), similar, full-thickness restoration of retinal layers was observed, particularly in areas of the outer periphery of the transition zone. The transition zone may represent the ideal area to target with cell therapy as the surviving photoreceptors may be restored to normal function with the transplant of new, allogeneic RPE. The first Cohort 4 patient with evidence of retinal restoration and confirmed history of GA growth, first reported last year, continues to demonstrate areas of retinal restoration through that patient’s most recent clinical visit, which occurred approximately 3 years post-transplant. These new findings have been confirmed utilizing multiple imaging technologies, including OCT, a non-invasive test which uses light waves to take cross-sectional images of the retina, allowing for visualization of each of the distinctive layers. The use of multiple imaging modalities differs from traditional assessment of GA progression, which employs only fundus autofluorescence (FAF) to assess changes in the total surface area of the apparent GA over time. Using only FAF may fail to identify structural changes that can be observed only with the addition of OCT imaging. The use of OCT allows for a more precise determination of changes in retinal thickness, organization, and overall health of the retina in areas of potential atrophy, which are possible with cell therapy. These changes may be more likely to be associated with improvements in visual acuity, reading speed, and quality of life over time.
Overall, OpRegen has been well tolerated with no unexpected adverse events or serious adverse events, and evidence of durable engraftment of OpRegen RPE cells have extended to more than 5 years post-transplant in earliest treated patients.
Dr. Monés has served as an external expert consultant for the OpRegen program for approximately 5 years. Dr. Monés completed his retinal specialist training at the Massachusetts Eye and Ear Infirmary at Harvard University, and earned his Ph.D. degree in Medicine and Surgery at the University of Barcelona.
Lineage plans to host a webinar with external therapeutic area experts to discuss the findings in detail, including a review of anatomical improvements, functional activity, and additional results of treatment with OpRegen. The Company will announce the date and time for this event in the coming days. The webinar will be available in the Events and Presentations section (https://investor.lineagecell.com/events-and-presentations/upcoming-events)of Lineage’s website.
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 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 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 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 https://twitter.com/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, including the findings of retinal restoration, from the ongoing Phase 1/2a of OpRegen, and the potential for issuance of new patents relating to OpRegen. 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/20210601005191/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 to Present at the Jefferies Virtual Healthcare Conference
MONMOUTH JUNCTION, N.J., May 27, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care leader commercializing its CytoSorb® blood purification technology to treat deadly conditions in critically ill and cardiac surgery patients around the world, announces that the Company will present an overview of the Company's progress and outlook at the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021. Company management will also meet with investors in 1x1 meetings throughout the day. To schedule a meeting with management, please contact your Jefferies representative.
Jefferies Healthcare Conference (https://www.jefferies.com/IdeasAndPerspectives/Conferences/325/060821)
When: Thursday, June 3, 2021 from 1:00-1:25PM EDT
Webcast: Jefferies Healthcare Conference Webcast Link (https://wsw.com/webcast/jeff174/register.aspx?conf=jeff174&page=ctso&url=https://wsw.com/webcast/jeff174/ctso/1867455)
CytoSorbents to present at the Jefferies Virtual Healthcare Conference
A live webcast of the presentation will be available at the above webcast link. An archived replay of the webcast will be available for 30 days following the event.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in treating life-threatening conditions in critical care and cardiac surgery, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 68 countries outside of the US, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that may result in massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death may be extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 131,000 human treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma), and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and 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 products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including ECOS-300CY™, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ™, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.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, 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.
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CytoSorbents Contact:
Amy Vogel
(732) 398-5394
mailto://avogel@cytosorbents.com
Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation
NEWS -- Vivos Inc. Expands IsoPet® Trademark Protection
Richland, WA, May 27, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL). Vivos Inc. previously filed to extend its IsoPet® trademark protection internationally.
We are pleased to report that the Commissioner for Trademarks at the U.S. Patent and Trademark Office has confirmed the filing and Certification of the ISOPET Madrid Protocol international application for use in connection with “Isotopes for veterinary use; radio-isotope markers for therapeutic veterinary purposes” in Class 5.
The International Bureau of the World Intellectual Property Organization (“WIPO”) reviewed the international application and determined it met the Madrid Protocol filing requirements. WIPO has registered the mark, published it in the WIPO Gazette of International Marks, and sent us the certificate of registration.
Each country designated in the registration (Australia, Brazil, Canada, European Union, Japan, Korea, Russia and the United Kingdom) has the right to object to extension of the registration to its country within 18 months from the date of the international registration.
Dr. Korenko stated, “The expansion of our trademark protection internationally is an important development given the increasing international interest in our Isopet® therapy and supports our mission to create a leading global brand for the treatment of tumors in pets through our Isopet global licensing initiative.”
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 FDA advised using different product names in order to avoid confusion and cross-use.
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 -- OncoSec to Present at the Raymond James Human Health Innovation Conference
PENNINGTON, N.J. and SAN DIEGO, May 27, 2021 /PRNewswire/ -- OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") today announced that management will present a company overview at the Raymond James Human Health Innovation Conference being held virtually Monday, June 21st – Wednesday, June 23rd, 2021.
Raymond James Human Health Innovation Virtual Conference
Date: Monday, June 21st
Time: 12:00pm ET
For those not attending the conference, a replay of the presentation will be available for 90 days in the "Events & Presentations" section of OncoSec's website at https://ir.oncosec.com/events-presentations.
About OncoSec Medical Incorporated
OncoSec Medical Incorporated (the "Company," "OncoSec," "we" or "our") is a biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec's lead immunotherapy investigational product candidate – TAVO™ (tavokinogene telseplasmid) – enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body. OncoSec has built a deep and diverse clinical pipeline utilizing TAVO™ as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from recently completed clinical studies of TAVO™ have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach along with an acceptable safety profile, warranting further development. In addition to TAVO™, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions. For more information, please visit https://www.oncosec.com.
TAVO™ is a trademark of OncoSec Medical Incorporated.
Company Contact
Brian Leuthner
Chief Operating Officer
mailto://investors@oncosec.com
Media Contact
Patrick Bursey
LifeSci Communications
+1-646-970-4688
mailto://pbursey@lifescicomms.com
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SOURCE OncoSec Medical Incorporated
NEWS -- Kintara Therapeutics Provides Positive Site Activation Update on GCAR Phase 2/3 Clinical Trial for Glioblastoma
SAN DIEGO, May 26, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM) has been activated in 15 U.S. sites as of May 14, 2021.
The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a patient-centered, adaptive platform trial for registration evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. Since January 2021, GCAR has accelerated the pace of clinical site activation with increased awareness in the medical community of Kintara's arm of the study. GCAR plans to enroll 150-200 patients in the Kintara arm of the study at 30 sites in the U.S. and Canada with potential to increase this total to 40 clinical trial centers.
"The entire Kintara team is enthused by the pace at which our treatment arm is being activated in the study," commented Saiid Zarrabian, Kintara's Chief Executive Officer. "With 15 sites already active, including prestigious centers such as Memorial Sloan Kettering, Henry Ford Cancer Institute, Columbia University Irving Cancer Research Center, Emory University Winship Cancer Institute, and the University of Florida, we are delighted to witness GCAR's exceptional clinical trial execution capabilities that drew us to participate in this exciting and highly efficient registrational study."
Key GBM AGILE Highlights for VAL-083
NEWS -- Aytu BioPharma to Present at Upcoming June Investor Conferences
ENGLEWOOD, CO / ACCESSWIRE / May 25, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, announced today that Josh Disbrow, Chairman and Chief Executive Officer, will present at two upcoming investor conferences in June:
NEWS -- CytoSorb® Registered and Commercially Available in Singapore
NEWS -- State of Tennessee Awards Funding for Public-Private Partnership to Study Animal Cancers and Dermatological Disorders using Provectus’ Medical Science Platform
KNOXVILLE, TN, May 25, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the State of Tennessee, as part of its fiscal year 2021-2022 budget, has directed funding in the amount of $2.5 million to develop animal health drug products through partnerships with state universities that have agriculture and veterinary medicine programs and the Knoxville-headquartered biotechnology company.
This study will pursue oncology, hematology, and dermatology treatments for companion and production animals, furthering research in these areas and eventual drug development. The foundation of this study is the Company’s halogenated xanthene medical science platform that already includes:
Some more good news ! https://twitter.com/radiogel/status/1396871510883594240/photo/1
This Pr explains why the good doctor acquired the 30 million shares a few weeks back , he knows this technology is ready for the big league , the all-new perfected radiogel , and its new proprietary technology , and I hope they keep it a secret and no patents . This has buyout written all over it, let the new multi-billion dollar acquirer get the patents. My guess RDGL will get bought out early next year .
NEWS -- Vivos Inc Enhances Radiogel™ Manufacturing Process
Richland WA, May 24, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), During the past few months Vivos has made significant enhancements to the manufacturing process for Radiogel™. These enhancements are crucial in aligning with FDA requirements for future clinical trials and licensing to international markets.
Our hydrogel and Y-90 particle production processes are safe and efficient and are being used to produce IsoPet® for animal therapy. Full FDA pedigreed pre-clinical testing and clinical trials require Good Manufacturing Practice (GMP) protocols described in detail in FDA regulations. The production improvements for Radiogel™ discussed were identified as part of establishing the GMP protocols for the IDE submission to the FDA.
This has been a substantial effort, including fifteen polymer runs to bound our design specifications, incorporation of more than fifty new Quality Management System documents, installation of new precision process control equipment, and a new Y-90 particle sterilization process. We are also assessing a contract with an international company that has the potential to produce a substantial amount of GMP RadioGel™ and IsoPet® both domestically and internationally.
This effort has strengthened our internal proprietary intellectual property. We discovered non-obvious and novel polymer/hydrogel production techniques that are significant and not published or mentioned in any patents. We are currently evaluating whether to keep these discoveries as a proprietary trade secret or to file additional patents. These manufacturing details have been incorporated in revisions to our Standard Operating Procedures for Hydrogel and Particle Production. With the essential elements of these enhancements now completed, we will accelerate our pre-clinical testing and now anticipate filing the IDE with the FDA in the next 90-120 days. Submitting the IDE after these manufacturing process enhancements were completed creates a much stronger submission with FDA and greatly reduces the risk and expense of having to do repeat testing.
Dr. Korenko stated “This effort has been substantial over the last several months, and is an invaluable investment necessary to transform our company into a serious commercial entity that has the potential to treat both animal and humans both domestically and internationally. We are confident that these manufacturing enhancements improve our proprietary technology and significantly strengthen our upcoming IDE submission.”
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.
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 -- Heat Biologics Announces Promising Survival Data of HS-110 in Two Treatment Settings of Lung Cancer; Selected for Presentation at 2021 American Society of Clinical Oncology Annual Meeting
DURHAM, N.C., May 20, 2021 (GLOBE NEWSWIRE) -- 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 the latest data from HS-110, the Company’s lead product, has been accepted for poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held virtually from June 4-8, 2021. The ASCO Annual Meeting is the largest international conference to showcase the latest advancements in oncology.
NEWS -- Oncolytics Biotech® Announces Clinical and Biomarker Data Demonstrating Clinical Proof-of-Concept for Pelareorep-Checkpoint Inhibitor Combination in Pancreatic Cancer
The study achieved a 42% disease control rate in difficult-to-treat, second-line pancreatic cancer patients despite the absence of chemotherapy in the treatment regimen
Pelareorep and pembrolizumab synergize to generate anti-cancer immune responses in patients showing disease control
Clinical response was associated with increased activation of anti-cancer CD8+ T cells
SAN DIEGO, Calif. and CALGARY, AB, May 20, 2021 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer. The data will be featured in an upcoming electronic poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place virtually from June 4 – 8, 2021.
The newly announced data are from a phase 2 trial evaluating pelareorep in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®) in pancreatic adenocarcinoma patients who progressed after first-line treatment. Findings from the trial indicate that pelareorep and pembrolizumab synergize and show anti-cancer activity in these difficult-to-treat patients, which is mediated through the complementary immunotherapeutic effects of the two agents.
"These results are very promising, particularly considering the extremely challenging patient population enrolled in the trial. That we saw a response signal in select patients, despite the absence of chemotherapy, provides evidence of the considerable anti-cancer activity of pelareorep-pembrolizumab combination therapy," said Principal Investigator, Devalingam Mahalingam, M.D., Ph.D., Associate Professor of Medicine at The Northwestern University Feinberg School of Medicine and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "We notably observed an association between treatment-induced anti-cancer immune responses and improved tumor control in some patients, which demonstrates pelareorep's underlying immunologic mechanism of action and validates the strategy of combining it with checkpoint inhibition. I look forward to discussing these data with the scientific community at the upcoming ASCO conference and to the continued evaluation of pelareorep-checkpoint inhibitor combination therapy in select patients with pancreatic and other gastrointestinal cancers."
The data presented in the upcoming ASCO poster represent an update based on additional data that was collected after the cutoff date used for the poster's corresponding abstract. Key data and conclusions that will be featured in this upcoming poster include:
NEWS -- FuelPositive Announces Manufacturing Partnership With National Compressed Air for Commercial Hydrogen-Ammonia Synthesizing System Development
TORONTO, May 19, 2021 (GLOBE NEWSWIRE) -- FuelPositive Corporation (“FuelPositive” or the “Company”) (TSX.V: NHHH) (OTC: NHHHF) is pleased to announce the selection of National Compressed Air Canada Ltd. (NCA) to undertake the manufacturing of the Company’s Phase 2 Hydrogen-Ammonia Synthesizer commercial prototype systems for Carbon-Free Ammonia (NH3) production.
“This critical milestone for FuelPositive will confirm the broad application potential for our technology and is the backbone of our Carbon-Free Hydrogen-NH3 offering,” said Ian Clifford, CEO of FuelPositive. “Partnering with the knowledgeable and experienced team at NCA on this commercialization project will bring our development-stage program to life.”
Traditional ammonia manufacturing currently exists on a massive scale, in centralized facilities and results in some of the world’s most concentrated CO2 emissions. With 200 million metric tonnes of NH3 consumed per year, 80 per cent of which is utilized by the agricultural sector, traditional NH3 is responsible for significant greenhouse gas emissions.
“FuelPositive’s modular and transportable systems leveraging various shipping container configurations will be suitable to offer a broad range of Carbon-Free Hydrogen-NH3 capabilities across a multitude of end-user applications,” added Mr. Clifford. “This flagship project could pave the way for the broad acceptance of ammonia as a fossil fuel replacement.”
FuelPositive’s Carbon-Free Hydrogen-NH3 system will be adaptable to multiple applications, from smaller stand-alone fuel generation systems for transportation companies, to larger agricultural systems for significant farming enterprises, all the way to large grid storage systems for hydro, wind, solar or geothermal electricity generation operations.
“It is an exceptional day to see our technology take the next step towards commercialization,” said Dr. Ibrahim Dincer, co-inventor of the FuelPositive Hydrogen-NH3 system. “We will work closely with the NCA engineers on this commercialization project, which we have every confidence will make a consequential positive change in reducing global CO2 emissions.”
With more than 50 years experience, NCA is an industry leader in the development, manufacturing, and servicing of transportable compressors using multiple gasses and highly specialized exploration equipment, making them an ideal partner to collaborate with on this project.
“We are extremely pleased to have been approached by the FuelPositive team to partner on this innovative and extremely important environmental project,” said Derek Keddie, President of National Compressed Air. “Our team of experienced engineers with specialization in relevant technologies will work intensively with the Company and Dr. Dincer’s team to prove the scalability and commercial viability of clean NH3 production.”
About FuelPositive
FuelPositive is a Canadian-based growth stage company committed to providing commercially viable and sustainable clean energy solutions, including Carbon-Free Hydrogen-Ammonia (NH3), for use across a broad spectrum of industries and applications.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
All statements, other than statements of historical fact, contained in this press release including, but not limited to (i) generally, or the “About FuelPositive” paragraph which essentially describes the Company’s outlook and objectives, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.
Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law.
For Media or Investor enquiries, please contact:
Mr. Ian Clifford
Chief Executive Officer
mailto://investors@fuelpositive.com
Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com
NEWS -- Navidea Biopharmaceuticals Announces Issuance of U.S. Patent for Diagnosis and Treatment of Viral Infections
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 the U.S. Patent and Trademark Office (“USPTO”) issued to Navidea U.S. patent 11,007,272, entitled “Compounds and Methods for Diagnosis and Treatment of Viral Infections,” with protection to October 7, 2037.
This patent protects the use of Navidea’s mannosylated dextran-based drug delivery vehicles to deliver small molecule therapeutic payloads as possible therapies for a variety of diseases caused by a group of viruses known as flaviviruses. Specific flaviviruses disclosed in the patent include those that cause dengue, yellow fever, and Zika fever. Dengue is a common serious illness in many tropical countries, with an estimated 100-400 million infections per year according to the World Health Organization.
In humans, these flaviviruses replicate extensively, and sometimes nearly exclusively, in CD206+ macrophages. CD206+ macrophages are the primary intended targets of Navidea’s mannosylated dextran-based drug delivery vehicles, making them capable of delivering potent drugs to the cells where the virus is multiplying.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “Our targeted therapeutics have the potential to address the large unmet medical need caused by flaviviruses given deficiencies in current therapies and/or vaccines.” Dr. Rosol continued, “The technology covered in this patent could also have implications for possible treatments of other infectious diseases where our platform might have an impact, including HIV and hepatitis C.”
Jed Latkin, Chief Executive Officer for Navidea, said, “I am proud of the work that our chemists have been doing and we continue to move the ball forward and perfect the intellectual property to protect our portfolio for the future.“
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/20210519005204/en/
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Heat Biologics Announces Multiple Presentations on PTX-35 at the Upcoming 3rd Annual Treg Directed Therapies Summit
GlobeNewswire Inc. -- 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 PTX-35 will be featured in several presentations and panel discussions at the 3rd Annual Treg Directed Therapies Summit on May 19-20. PTX-35 is a novel, potential first-in-class antibody modulating TNFRSF25 (death receptor 3 or DR3), a receptor that is preferentially expressed by antigen-experienced T-cells.
NEWS -- CytoSorbents to Present at the UBS Global Healthcare Virtual Conference and Oppenheimer MedTech, Tools and Diagnostic Summit
MONMOUTH JUNCTION, N.J., May 19, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care leader commercializing its CytoSorb® blood purification technology to treat deadly conditions in critically ill and cardiac surgery patients around the world, announces that the Company will present an overview of the Company's progress and outlook at the UBS Global Healthcare Virtual Conference and provide a prerecorded presentation at the Oppenheimer MedTech, Tools and Diagnostic Summit on Wednesday, May 26, 2021. Company management will also meet with investors in 1x1 meetings throughout the day. To schedule a meeting with management, please contact your UBS and Oppenheimer representative.
CytoSorbents to present at the UBS Healthcare Conference and Oppenheimer MedTech, Tools and Diagnostic Summit
UBS Healthcare Conference
When: Wednesday, May 26, 2021 from 3:00-3:30PM EDT
Webcast: UBS Healthcare Conference Webcast Link (https://event.webcasts.com/starthere.jsp?ei=1458217&tp_key=2657878517)
A live webcast of the presentation will be available at the above webcast link. An archived replay of the webcast will be available for 30 days following the event.
Oppenheimer MedTech, Tools and Diagnostic Summit
When: Wednesday, May 26, 2021
Webcast: Oppenheimer Summit Webcast Link (https://wsw.com/webcast/oppenheimer13/register.aspx?conf=oppenheimer13&page=ctso&url=https://wsw.com/webcast/oppenheimer13/ctso/2797920)
A live webcast of the presentation will be available at the above webcast link. An archived replay of the webcast will be available for 90 days following the event.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in treating life-threatening conditions in critical care and cardiac surgery, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 68 countries outside of the US, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that may result in massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death may be extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 131,000 human treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma), and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and 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 products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including ECOS-300CY™, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ™, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.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, 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.
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CytoSorbents Contact:
Amy Vogel
(732) 398-5394
mailto://avogel@cytosorbents.com
Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation
NEWS -- OncoSec Appoints Robert M. Schinagl, Ph.D. as Vice President of Program and Alliance Management
PENNINGTON, N.J. and SAN DIEGO, May 17, 2021 /PRNewswire/ -- OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") today announced the appointment of Robert M. Schinagl, Ph.D., a biotech industry veteran with over 20 years of experience, as Vice President of Program and Alliance Management, effective May 17, 2021.
"We are thrilled to welcome Dr. Schinagl to OncoSec's management team as the company continues to make progress in the development of our lead product candidate, TAVO™," said Daniel J. O'Connor, President and Chief Executive Officer of OncoSec. "As we actively seek opportunities through strategic partnerships and uphold our mission to bring transformative solutions to patients in need, we believe Dr. Schinagl's significant leadership expertise in project and alliance management will help drive OncoSec in the direction of joining forces and leveraging a fully-integrated immuno-oncology platform."
Dr. Schinagl added, "I am excited to work with Dan and the OncoSec leadership team at a pivotal point in the Company's history as it continues to advance TAVO through clinical development. I look forward to helping the Company continue its positive momentum and working with potential partners to bring its ground-breaking science to patients not benefitting from currently available cancer treatments."
Dr. Schinagl most recently served as Chief Operating Officer at Prothex Pharma, Inc., where he was responsible for strategy, clinical development, regulatory affairs, business development, and portfolio and alliance management. He led all regulatory and health authority interactions and led drug development teams, driving collaboration among employees, consultants, academic experts, vendors and partners. Dr. Schinagl supported business development by assessing in-license opportunities and coordinating due diligence efforts for out-licensing, and he was a member of the Prothex's joint development committees.
Prior to Prothex, Dr. Schinagl held a variety of project and alliance leadership positions at Drais Pharmaceuticals, Eli Lilly, ImClone Systems, Yamanouchi Pharma America, Quintiles Advanced Phase Solutions, and Osiris Therapeutics. In these roles, Dr. Schinagl led a range of leading drug development programs largely focused on oncology. Dr. Schinagl earned doctorate and master's degrees in bioengineering at the University of California, San Diego and his bachelor's degree in bioengineering at the University of Pennsylvania.
As of May 17, 2021, Dr. Schinagl will be granted an initial grant of 35,000 stock options. These stock options will have an exercise price equal to the closing price of the Company's common stock on the date of grant and will be 25% vested on the date of grant, with the remaining 75% vesting quarterly over a two-year period. These stock options were granted as an inducement to Dr. Schinagl entering into employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).
About TAVO™
OncoSec's gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.
About OncoSec Medical Incorporated
OncoSec Medical Incorporated (the "Company," "OncoSec," "we" or "our") is a biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec's lead immunotherapy investigational product candidate – TAVO™ (tavokinogene telseplasmid) – enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body. OncoSec has built a deep and diverse clinical pipeline utilizing TAVO™ as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from recently completed clinical studies of TAVO™ have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach along with an acceptable safety profile, warranting further development. In addition to TAVO™, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions. For more information, please visit https://www.oncosec.com.
TAVO™ is a trademark of OncoSec Medical Incorporated.
Risk Factors and Forward-Looking Statements
This release, as well as other information provided from time to time by the Company or its employees, may contain forward-looking statements that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Forward-looking statements provide the Company's current beliefs, expectations and intentions regarding future events and involve risks, uncertainties (some of which are beyond the Company's control) and assumptions. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "should," "will" and "would" and similar expressions (including the negative of these terms). Although we believe that expectations reflected in the forward- looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. The Company intends these forward-looking statements to speak only at the time they are published on or as otherwise specified, and does not undertake to update or revise these statements as more information becomes available, except as required under federal securities laws and the rules and regulations of the Securities Exchange Commission ("SEC"). In particular, you should be aware that the success and timing of our clinical trials, including safety and efficacy of our product candidates, patient accrual, unexpected or expected safety events, the impact of COVID-19 on the supply of our candidates or the initiation or completion of clinical trials and the usability of data generated from our trials may differ and may not meet our estimated timelines. Please refer to the risk factors and other cautionary statements provided in the Company's Annual Report on Form 10-K for the fiscal year ended July 31, 2019 and subsequent periodic and current reports filed with the SEC (each of which can be found at the SEC's website www.sec.gov), as well as other factors described from time to time in the Company's filings with the SEC.
Company Contact
Brian Leuthner
Chief Operating Officer
mailto://investors@oncosec.com
Media Contact
Patrick Bursey
LifeSci Communications
+1-646-970-4688
mailto://pbursey@lifescicomms.com
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SOURCE OncoSec Medical Incorporated
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NEWS -- NanoViricides Has Filed Quarterly Report for Period Ending March 31, 2021 - Has Sufficient Cash, Coronavirus Drug Candidate Moving Towards IND
SHELTON, CT / ACCESSWIRE / May 17, 2021 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform (the "Company"), has filed its quarterly report for its third quarter of financial year 2021 with the Securities and Exchange Commission. This press release should be read in conjunction with the Company's Form 10-Q filed on May 14, 2021. The submission can be downloaded from the SEC website at: https://www.sec.gov/Archives/edgar/data/1379006/000110465921066909/tm2111798d1_10q.htm.
The Company reported that it had approximately $23.23 million of current assets (cash, cash equivalents, and prepaid expenses), and current cash liabilities of approximately $0.87 million. As of March 31, 2021 the Company has no debt, and Stockholder's equity was approximately $31.89 million. During the nine-month period ended March 31, 2021 approximately $5.99 M in cash was used toward operating activities. The Company had no revenues. (All figures are unaudited).
The Company believes it has sufficient funds for initial human clinical trials of at least one of its drug candidates.
We are currently focused on advancing our drug candidates for treatment of patients with COVID-19 infection towards human clinical trials, in response to the current pandemic. We are working on a pre-IND application for COVID-19 treatment at present. We have previously completed IND-enabling studies for a drug candidate for the treatment of shingles rash caused by reactivation of the chickenpox virus (aka varicella-zoster virus, VZV). We plan on taking the shingles drug candidate into human clinical trials after clinical trials of our COVID-19 drug candidate.
We are developing a broad-spectrum antiviral drug candidate, NV-CoV-2, where the potential for escape of virus variants is minimized by the very design of the drug for the treatment of COVID-19 infected sick persons. In contrast, vaccines are not treatments for sick persons, and must be administered to healthy individuals, and further require several weeks for the recipient's immune system to become capable of protecting against the target virus strain which still may not protect against new virus variants circulating by that time.
In addition to NV-CoV-2, we are also developing another anti-coronavirus drug candidate, NV-CoV-2-R. This drug candidate is comprised of holding remdesivir inside our polymeric drug candidate NV-CoV-2 by a process known as encapsulation. Thus NV-CoV-2-R is potentially capable of (1) direct attack on extracellular virus, to break the "re-infection cycle" by virtue of the activity of NV-CoV-2, and (2) attack on intracellular reproduction of the virus to break the "replication cycle" as has been validated for remdesivir. If both of these cycles are broken, in theory, it is expected to result in a cure of the virus infection. Remdesivir is a challenging drug, because it is rapidly converted by blood and cellular enzymes into a significantly less potent form. It is also almost insoluble in aqueous media. Encapsulation of remdesivir in NV-CoV-2 is expected to solve these problems. Encapsulation inside NV-CoV-2 is expected to protect remdesivir from the rapid bodily metabolism, thereby raising the effective drug concentration in the body, and it is also expected to make effective drug available over a longer period of time than the Gilead formulation of remdesivir.
It is important to develop NV-CoV-2 by itself as a drug because the inherent toxicity of remdesivir which can be inferred from its molecular structure may limit its usage in certain patient populations.
We have recently completed safety pharmacology studies required for filing an IND application with the US Food and Drug Administration ("FDA") of our COVID-19 drug candidate NV-CoV-2. We have received an audited report on the GLP safety/pharmacology studies from the Company's external CRO and expect to receive the remaining report(s) soon. We are also awaiting written reports of non-GLP safety/toxicology studies and non-GLP animal efficacy antiviral efficacy studies. We are also preparing a pre-IND application for submission to the US FDA for our pan-coronavirus drug candidates to obtain further guidance and plan on submitting an IND application thereafter. We are in the process of identifying and engaging clinical study sites for the Phase 1 and Phase 2 human clinical trials of these broad-spectrum coronavirus infection treatments, in the USA as well as abroad.
We have reported in press releases that both NV-CoV-2 and NV-CoV-2-R were found to be substantially superior to remdesivir in antiviral effect based on an animal model of lethal coronavivirus infection that mimics the SARS-CoV-2 lung infection disease. Compared to treatment with remdesivir, treatment with the Company's drug candidate NV-CoV-2 alone extended the lifespan by approximately four times more days. Further, treatment with the Company's other drug candidate NV-CoV-2-R extended the lifespan approximately five times longer. Remdesivir treatment alone extended the lifespan of animals by only about 2 days in this lethal infection study.
In addition, we have reported in a press release that both of these drug candidates have been found to be effective against multiple coronaviruses in cell culture.
Thus we believe that both of our COVID-19 drug candidates, NV-CoV-2 and NV-CoV-2-R, possess broad-spectrum, pan-coronavirus effectiveness and thus would be effective against all variants of SARS-CoV-2.
The need for the broad-spectrum, pan-coronavirus nanoviricide drug treatment cannot be overstated for combating the COVID-19 pandemic given the current circumstances and the present status of the pandemic. New virus variants continue to develop in the field. The variants that have advantages in terms of transmissibility, infectivity, and escape from antibodies, drugs and vaccines will continue to evolve and spread, replacing prior variants. This is already well documented.
The devastatingly severe "second wave" of the pandemic in India that is currently raging appears to have been traced to new variants, including the UK variant B.1.1.7, and novel variants found in India, namely N400K, and a so-called "double mutant" variant, B.1.617. Of these, B.1.617 appears to be taking over and appears to be both more transmissive, severe, and is likely escaping antibodies from previous infections in patients.
Several vaccines have been found to be substantially less effective in protecting against infection by the South African variant, N501Y- V.2 (also called lineage B.1.351) than the earlier variants. A mutation present in B.1.351 as well as Brazilian variant P.1 that is thought to be possibly linked to evasion from antibody drugs and vaccines, E484K, has also been reported in UK in a further differentiated mutant of the variant of concern lineage B.1.1.7. The available monoclonal antibody drugs and convalescent plasma antibodies have been reported to be less effective against several variants.
By the very nature of how they work, vaccines and antibodies tend to be highly specific to the target virus variant, and do not afford strong protection against differentiated variants that are evolutionary distant from the target variant. This scientific fact is now well demonstrated for the COVID-19 pandemic. Developing new vaccines against then known variants, a strategy that is now being attempted is again subject to new variants spreading in the field prior to any possibility of sufficient vaccination with the new vaccine boosters. The goal of herd immunity has also become elusive and now it is being thought of as unattainable even in the USA.
NanoViricides is one of a few biopharma companies that operates its own cGMP-compliant manufacturing facility. The Company intends to produce its drugs for clinical trials in this facility. The Company has the capability to produce sufficient drugs for about 1,000-5,000 patients in a single batch of production, depending upon the drug and the dosage. This production capacity is anticipated to be sufficient for first-in-human use in the current SARS-CoV-2 pandemic for our anti-coronavirus drug in development, as well as for the anticipated clinical trials of NV-HHV-101 skin cream for the treatment of shingles.
The Company has developed NV-CoV-2 based on its platform nanoviricides® technology. This approach enables rapid development of new drugs against a number of different viruses. A nanoviricide is a "biomimetic" - it is designed to "look like" the cell surface to the virus. The nanoviricide technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only two attachment points per antibody.
It is anticipated that when a virus comes in contact with the nanoviricide, not only would it land on the nanoviricide surface, binding to the copious number of ligands presented there, but it would also get entrapped because the nanomicelle polymer would turn around and fuse with the virus lipid envelope, harnessing a well known biophysical phenomenon called "lipid-lipid mixing". In a sense, a nanoviricide drug acts against viruses like a "venus-fly-trap" flower does against insects. Unlike antibodies that tag the virus and require the human immune system to take over and complete the task of dismantling the virus, a nanoviricide is a nanomachine that is designed to not only bind to the virus but also complete the task of rendering the virus particle ineffective.
In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide® technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.
The Company has developed NV-CoV-2-R based on this encapsulation capability that is built in its nanoviricide NV-CoV-2. The Company has chosen to encapsulate "remdesivir" as the participating drug for blocking the viral replication cycle. Remdesivir is approved by the US FDA for the treatment of SARS-CoV-2 infection. Encapsulation of remdesivir in the Company's nanoviricide envelope is expected to protect it from metabolism in the body. This protection can be expected to lead to significant enhancement in the effectiveness of remdesivir itself (in the encapsulated form), by potentially increasing both the effective remdesivir concentration and its duration of action. This could be an additional favorable effect for the Company's anti-coronavirus drug candidate NV-CoV-2-R. Remdesivir is sponsored by Gilead. The Company is developing its drug candidates independently at present.
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. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, we are developing a clinical candidate for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. 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 now working on tasks for completing an IND application. 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 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 has executed a Memorandum of Understanding with TheraCour that provides a limited license for research and development for drugs against human coronaviruses. The Company intends to obtain a full license and has begun the process for the same. 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 which 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
Public Relations Contact:
MJ Clyburn
TraDigital IR
mailto://clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
View source version on accesswire.com:
https://www.accesswire.com/647686/NanoViricides-Has-Filed-Quarterly-Report-for-Period-Ending-March-31-2021--Has-Sufficient-Cash-Coronavirus-Drug-Candidate-Moving-Towards-IND
NEWS -- Kintara Therapeutics Announces Fiscal Third Quarter 2021 Financial Results and Provides Corporate Update
SAN DIEGO, May 14, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced financial results for its fiscal third quarter ended March 31, 2021 and provided a corporate update.
Fiscal Third Quarter Highlights and Recent Developments
NEWS -- Lineage Reports First Quarter 2021 Financial Results and Highlights Significant Progress With All Three Clinical Programs
NEWS -- Lineage Cell Therapeutics, Inc. to Host Earnings Call
NEW YORK, NY / ACCESSWIRE / May 13, 2021 / Lineage Cell Therapeutics, Inc. (AMEX:LCTX) will be discussing their earnings results in their 2021 First Quarter Earnings call to be held on May 13, 2021 at 4:30 PM Eastern Time.
To listen to the event live or access a replay of the call - visit
https://www.investornetwork.com/event/presentation/78927
To receive updates for this company you can register by emailing mailto://info@investornetwork.com or by clicking get investment info from the company's profile.
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NEWS -- Innovation Pharma Files Form 10-Q; Patient Enrollment in Phase 2 Clinical Trial of Brilacidin for COVID-19 Tops 70 Percent
WAKEFIELD, Mass., May 13, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces the filing (https://www.sec.gov/edgar/browse/?CIK=1355250) of its SEC Form 10-Q (quarterly report), for the quarter ended March 31, 2021. During the quarter, the Company made substantive progress in the development of Brilacidin, Innovation Pharma’s flagship drug candidate in a new class of compounds called defensin-mimetics.
Of particular note, in January, the U.S. Food and Drug Administration (FDA) designated the investigation of Brilacidin for the treatment for COVID-19 as a Fast Track development program.
In February, recruitment began for the Company’s international Phase 2, ~120-patient, randomized, double-blind, placebo-controlled clinical trial evaluating Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897). Early in April, enrollment in the trial reached 25 percent. Upon review of safety data, per protocol, the independent Data Monitoring Committee (DMC) recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, which has been implemented and may further maximize Brilacidin’s therapeutic benefits. At the end of April, enrollment in the COVID-19 trial reached 50 percent, and as of today, the Company is pleased to report enrollment now exceeds 70 percent.
Since the COVID-19 outbreak, Brilacidin has garnered attention due to its unique 3-in-1 therapeutic potential—antiviral, anti-inflammatory, antimicrobial—to treat COVID-19 and associated complications. Extensive antiviral research conducted to date resulted in publication of findings related to Brilacidin’s anti-SARS-CoV-2 activity in Viruses, a peer-reviewed journal, with Brilacidin also selected for academic presentations, leading to added exposure for the Company. Further, an independent Machine Learning/Artificial Intelligence model used to screen 1,482 compounds ranked Brilacidin in the top three percent of compounds predicted to be the most effective against SARS-CoV-2, the virus responsible for COVID-19. The Company is encouraged by the Brilacidin antiviral data generated thus far, as it is supportive of Brilacidin’s potential to become a front-line antiviral treatment for COVID-19.
Also in the pipeline, Alfasigma S.p.A. (“Alfasigma”)—the licensee of worldwide rights to develop, manufacture and commercialize rectally-administered Brilacidin for treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS)—notified the Company, in April, of its intentions to commence, in 2021, a Phase 2 multinational clinical trial of Brilacidin for UP/UPS. Alfasigma has placed an order with the Company for Brilacidin drug substance needed for the trial, which the Company is in the process of supplying. Per the licensing agreement, Innovation Pharma is eligible to receive $24 million in upfront and milestone payments, and a 6 percent royalty (net sales), upon the successful marketing of Brilacidin for UP/UPS.
“It was a busy and productive quarter for us,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Patient enrollment in the Phase 2 study of Brilacidin for COVID-19 is moving along quickly, far faster in recruitment than other COVID-19 studies we’ve seen in industry reports. We are optimistic about Brilacidin’s COVID-19 treatment prospects, and are further encouraged by the broad spectrum antiviral properties Brilacidin is exhibiting based on ongoing lab research in multiple viruses.”
Ehrlich continued: “Elsewhere, it was exciting to learn that Alfasigma is planning to commence a Phase 2 trial of Brilacidin for treatment of UP/UPS this year, which complements our goal to develop oral Brilacidin in Inflammatory Bowel Diseases. That Alfasigma is investing substantial resources and monies in the clinical development of Brilacidin is a reassuring sign they continue to see therapeutic promise and commercial merit in Brilacidin in the area of IBD, as do we. Development work related to the formulation and manufacture of Brilacidin in capsule form is underway to support our Phase 2 trial in Ulcerative Colitis planned to commence this year. Additional work tied to starting, in 2022, a planned Phase 3 study of Brilacidin in Oral Mucositis is also in progress. We aim to maintain momentum across our clinical programs.”
Alerts
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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning future drug development plans, clinical trials, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other viruses, as well as obtaining government regulatory approvals to commence clinical testing; other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks but not limited to risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the US and other jurisdictions; that prior test results may not be replicated in future studies and trials, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the Company’s vendors may not produce Brilacidin drug substance or dosing formulations in compliance with the Company’s specifications required for clinical trials; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
mailto://info@ipharminc.com
NEWS -- Oncolytics Biotech® to Participate in Virtual Fireside Chat at the 2021 RBC Capital Markets Global Healthcare Conference
Fireside chat to take place on Wednesday, May 19 at 5:25 pm ET
SAN DIEGO and CALGARY, AB, May 13, 2021 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the Company will participate in a virtual fireside chat at the 2021 RBC Capital Markets Global Healthcare Conference, which is taking place virtually from May 18-20, 2021. Presentation details are listed below.
Presenter: Dr. Matt Coffey, President & Chief Executive Officer of Oncolytics Biotech Inc.
Date: Wednesday, May 19, 2021
Time: 5:25 pm Eastern Daylight Time
Webcast Link: Please click here (https://event.on24.com/wcc/r/3173476/2066CE1AC5D3697237B612E1FE048E86)
The Company will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please contact your RBC representative or email mailto://tim@lifesciadvisors.com.
A live webcast of the fireside chat will also be available on the Investor Relations page of Oncolytics' website (https://ir.oncolyticsbiotech.com/events-presentations) and will be archived for two weeks.
About Oncolytics Biotech Inc.
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.
Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-virtual-fireside-chat-at-the-2021-rbc-capital-markets-global-healthcare-conference-301290617.html
SOURCE Oncolytics Biotech® Inc.
NEWS -- Aytu BioPharma Announces Publication of In Vitro Study Demonstrating That Ultraviolet-A Light Increases Mitochondrial Anti-Viral Signaling Protein Within Cells
ENGLEWOOD, CO / ACCESSWIRE / May 12, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, announced today that in vitro data related to the ultraviolet (UV) A light used in the Healight™ UVA endotracheal catheter technology was published in BioRxiv, an online archive for health science manuscripts that are not yet peer reviewed.
The manuscript titled "Ultraviolet-A light increases mitochondrial anti-viral signaling protein via cell-cell communication" concluded that UVA light increases the expression of mitochondrial antiviral-signaling (MAVS) protein within cells, and the results suggest that this transmission of an increase in intracellular MAVS involves cell-to-cell communication. These findings confirm that an increase of MAVS in response to UVA light can be transmitted from cells directly exposed to UVA light to neighboring cells that have not been directly exposed to UVA light and suggest that cell-to-cell signaling is involved in the process of eliciting UVA light's antiviral effect.
"These latest findings continue to build upon the potential of the UVA light platform technology and may reveal the fundamental basis for the therapeutic effect of the specific UVA light used in the Healight endotracheal catheter . These findings point to the fact that direct exposure of cells to UVA light may not be required to elicit an antiviral effect against a pathogen like SARS-CoV-2 because the mitochondrial activation results in a wide-ranging cell-to-cell response which could result in an increased antiviral effect, "commented Josh Disbrow, chief executive officer of Aytu BioPharma.
In the study, MAVS levels were compared in primary human tracheal epithelial cells (HTEpC) exposed to narrow band (NB)-UVA light for 20 minutes and in unexposed controls, at 30-40% and at 100% cell culture confluency. MAVS levels were also compared in unexposed HTEpC cells treated with supernatants or lysates from UVA-exposed cells or from unexposed controls, and in cells from different sections of confluent monolayer plates where only one section of the plate was exposed to NB-UVA. This study did not test the use of the actual Healight device to treat COVID-19, the disease caused by the SARS-CoV-2 virus.
Normalized MAVS levels, as detected by western blot, were increased in NB-UVA exposed cells when compared to unexposed controls (P=0.0193). There were no changes in normalized MAVS levels, when naïve 30-40% confluent HTEpC cells were treated with supernatants or cell lysates from NB-UVA exposed 30-40% confluent HTEpC cells (P=0.4022, P=0.1256). Normalized MAVS levels gradually increased from section 4 (farthest unexposed area) through section 1 (closest area exposed to NB-UVA) (P=0.08), and there was a significant increase in MAVS levels in section 1 (exposed to NB-UVA) when compared to unexposed section 4 (P=0.0382).
About MAVS
Mitochondrial antiviral-signaling protein (MAVS) is a protein that is essential for antiviral innate immunity. MAVS is located in the outer membrane of the mitochondria, peroxisomes, and endoplasmic reticulum (ER). Upon viral infection, a group of cytosolic proteins will detect the presence of the virus and bind to MAVS, thereby activating MAVS. The activation of MAVS leads the virally infected cell to secrete cytokines. This induces an immune response which kills the host's virally infected cells, resulting in clearance of the virus.
To access the BioRxiv pre-print, click here:
https://www.biorxiv.org/content/10.1101/2021.05.11.443549v1
About Aytu BioPharma, Inc.
Aytu BioPharma is a specialty pharmaceutical company with a growing commercial portfolio of prescription therapeutics and consumer health products. The company's primary prescription products treat attention deficit hyperactivity disorder (ADHD) and other common pediatric conditions. Aytu markets ADHD products Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING). The company's other pediatric products include Karbinal® ER (carbinoxamine maleate), an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency. The company's evolution has been driven by strategic in-licensing, acquisition-based transactions and organic product growth. Aytu is building a complimentary therapeutic development pipeline including a prospective treatment (AR101/enzastaurin) for vascular Ehlers-Danlos Syndrome (vEDS), a rare genetic disease resulting in high morbidity and a significantly shortened lifespan. There are no currently approved treatments for vEDS. To learn more, please visit https://aytubio.com.
Forward-Looking Statements
This press release includes 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, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements, including but not limited to any statements regarding the scientific or clinical results from the Healight studies, the potential regulatory authorizations or approvals that may be enabled by such studies, the market potential of Healight, and any factors that could influence any future commercialization plans for Healight t We also refer you to (i) the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission and (ii) the Risk Factors set forth in Aytu's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC.
Contact for Media and Investors:
Sarah McCabe
Stern Investor Relations, Inc.
mailto://sarah.mccabe@sternir.com
SOURCE: Aytu BioPharma, Inc.
View source version on accesswire.com:
https://www.accesswire.com/646801/Aytu-BioPharma-Announces-Publication-of-In-Vitro-Study-Demonstrating-That-Ultraviolet-A-Light-Increases-Mitochondrial-Anti-Viral-Signaling-Protein-Within-Cells
NEWS -- Navidea Biopharmaceuticals Reports First Quarter 2021 Financial Results
Conference Call to be held Tuesday, May 11, 2021 at 5:00 pm EDT
May 11, 2021 04:01 PM Eastern Daylight Time
DUBLIN, Ohio -- (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 its financial results for the first quarter for the period ended March 31, 2021.
“We are continuing a positive dialogue with the FDA and are moving as quickly as we can to fully document all the data from Arm 3 of NAV3-31,” said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. “We are also excited to begin patient enrollment for NAV3-32 both here in the U.S. and in the UK.”
First Quarter 2021 Highlights and Subsequent Events