Einstieg lohnenswert
https://ir.tonixpharma.com/all-sec-filings?page=2#
"FOR approval of an amendment to the Company’s Articles of Incorporation, as amended, to increase the number of shares of the Company’s common stock authorized for issuance from 150,000,000 to 400,000,000 (Proposal No. 1 – the “Proposal to Increase Authorized Shares”)"
Tja kann er doch gut rechtfertigen, dass er 400Mil USD braucht, um gleich 4 Impfstoffe herzustellen. So ein Witz. Hoffen wir, dass der Preis noch mal in die Hoehe geht.
https://www.pharmaceutical-technology.com/news/...-covid-19-vaccines/
Quelle: https://www.reuters.com/article/...uticals-says-will-pr-idUSFWN2CX11P
Der Kurs kann auch sehr schnell von 0,64 auf 2,50 springen innerhalb eines Tages,
bei entsprechender News. Und tagsdrauf - ups - sind wir plötzlich bei 3-4 Euro.
Zudem sind viele - sehr viele - z.Zt. frustriet, da der Kurs nun schon seit 8 Wochen,
fast nichts macht und dahin dümpelt. Viele haben deshalb auch schon verkauft.
Unser Tag wird kommen. Wir brauchen Nerven und auch etwas Geduld.
Sonniges Wochenende an alle.
Dr. Gregory Sullivan, Chief Medical Officer of Tonix said, “The recruitment of Dr. Harris to our management team is opportune, arriving at a time Tonix has launched its COVID-19 program and expanded its pipeline of clinical candidates including those in addiction, mood disorders, and geriatric psychiatry. Dr. Harris’ career has exemplified the translational tradition of bringing bench to bedside, with extensive training and research in our Nation’s premier academic and National Institutes of Health (NIH) intramural programs. Moreover, he has applied that expertise to pharmaceutical drug development in industry for many years, and thus brings to Tonix a wealth of experience advancing therapeutics in critical underserved areas that align well with our mission. He will be an asset to both our management team and to the development of our pipeline as Tonix advances its therapeutics, with the goal of ultimately delivering much needed therapeutics for the benefit of patients.”
“It’s exciting to join a company with such an experienced management team and sense of purpose towards finding treatments for underserved populations,” said Dr. Harris. “Developing the COVID-19 vaccine is particularly exciting because T cell immunity has been a great interest since my doctoral work. I believe T cell immunity, and particularly TH1 type immunity, will be important in protecting against serious COVID-19 disease and in clearing the virus. Clearing the virus, which I believe requires CD8 T cell immunity in similar viral illnesses, will be important to decreasing forward transmission. I look forward to offering my capabilities and strategic mindset to the Tonix team as the company continues to grow and progress its pipeline.”
Dr. Harris earned his M.D. and Ph.D. degrees from the University of Pittsburgh. Dr. Harris’ Ph.D. work in immunology involved the regulation of cell surface expression and turnover of Class I MHC antigens, which are the targets of CD8 T cells. Class I MHC proteins play a crucial role in directing T cell-mediated immune responses in transplantation and antiviral immunity. The regulation of these proteins by cytokines was a central focus of this work. Dr. Harris completed residency training in psychiatry at Yale University. He performed postdoctoral research on the neurobiology of addiction in the laboratory of Dr. Eric Nestler, M.D., Ph.D. After the completion of clinical training, Dr. Harris served as Senior Staff Fellow at the National Institute on Aging, a division of the NIH, where his research focused on the mechanisms of programmed cell death in neurons. He subsequently served as Chief of the Geriatric Psychopharmacology Program and Chief of the Adult Psychopathology Branch at the National Institute of Mental Health. He also served as scientific liaison to the Neuropharmacology Division of the U.S. Food and Drug Administration. Dr. Harris subsequently joined industry and has devoted more than two decades to drug discovery and development at companies that include Merck, Cephalon, GlaxoSmithKline, and Jazz Pharmaceuticals. In addition, he has served as Tonix’s Chief Medical Officer from 2009 to 2011 and for other early-stage companies that include Vela Pharmaceuticals, Validus Pharmaceuticals. Dr. Harris served on the Scientific Advisory Board of Tonix for approximately 10 years until his appointment as Tonix’s Executive Vice President, Translational Medicine.
NEWS NEW YORK, 19. Mai 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix oder das Unternehmen), ein biopharmazeutisches Unternehmen in der klinischen Phase, gab heute die Ernennung von Dr. Herbert Harris zum neuen Executive Vice President, Translational Medicine, mit Wirkung zum 15. Mai 2020 bekannt. In dieser Funktion wird sich Dr. Harris darauf konzentrieren, die präklinische Pipeline von Tonix voranzubringen, einschließlich des potenziellen COVID-19-Impfstoffs in die Klinik, und an den laufenden klinischen Programmen von Tonix teilnehmen. Dr. Gregory Sullivan, Chief Medical Officer von Tonix, sagte: "Die Einstellung von Dr. Harris in unser Management-Team kommt genau zum richtigen Zeitpunkt, da Tonix sein COVID-19-Programm gestartet und seine Pipeline klinischer Kandidaten erweitert hat, darunter solche in den Bereichen Sucht, Stimmungsstörungen und geriatrische Psychiatrie. Die Laufbahn von Dr. Harris ist ein Beispiel für die translationale Tradition, das Krankenbett ans Bett zu bringen, mit umfassender Ausbildung und Forschung in den führenden akademischen und intramuralen Programmen unserer Nation und der National Institutes of Health (NIH). Darüber hinaus hat er dieses Fachwissen seit vielen Jahren auf die pharmazeutische Arzneimittelentwicklung in der Industrie angewandt und bringt somit einen reichen Erfahrungsschatz in Tonix ein, um Therapeutika in kritischen, unterversorgten Bereichen voranzubringen, die gut mit unserer Mission übereinstimmen. Er wird eine Bereicherung sowohl für unser Managementteam als auch für die Entwicklung unserer Pipeline sein, wenn Tonix seine Therapeutika vorantreibt, mit dem Ziel, letztendlich dringend benötigte Therapeutika zum Wohle der Patienten zu liefern". "Es ist aufregend, sich einem Unternehmen mit einem so erfahrenen Managementteam anzuschliessen, das sich zum Ziel gesetzt hat, Therapien für unterversorgte Bevölkerungsgruppen zu finden", sagte Dr. Harris. "Die Entwicklung des COVID-19-Impfstoffs ist besonders aufregend, weil die T-Zell-Immunität seit meiner Doktorarbeit auf grosses Interesse stösst. Ich glaube, dass die T-Zell-Immunität und insbesondere die Immunität vom TH1-Typ für den Schutz vor der schweren COVID-19-Krankheit und für die Beseitigung des Virus wichtig sein wird. Die Reinigung des Virus, die meiner Meinung nach bei ähnlichen Viruserkrankungen eine CD8-T-Zell-Immunität erfordert, wird für die Verringerung der Vorwärtsübertragung wichtig sein. Ich freue mich darauf, dem Tonix-Team meine Fähigkeiten und meine strategische Einstellung zur Verfügung zu stellen, während das Unternehmen weiter wächst und seine Pipeline weiterentwickelt". Dr. Harris erwarb seinen M.D. und seinen Doktortitel an der Universität von Pittsburgh. Dr. Harris' Doktorarbeit auf dem Gebiet der Immunologie befasste sich mit der Regulation der Zelloberflächenexpression und des Umsatzes von MHC-Antigenen der Klasse I, die das Ziel von CD8 T-Zellen sind. MHC-Proteine der Klasse I spielen eine entscheidende Rolle bei der Steuerung T-Zell-vermittelter Immunantworten bei Transplantationen und antiviraler Immunität. Die Regulation dieser Proteine durch Zytokine war ein zentraler Schwerpunkt dieser Arbeit. Dr. Harris absolvierte eine Facharztausbildung in Psychiatrie an der Universität Yale. Nach Abschluss der klinischen Ausbildung war Dr. Harris als Senior Staff Fellow am National Institute on Aging, einer Abteilung des NIH, tätig, wo sich seine Forschung auf die Mechanismen des programmierten Zelltods in Nervenzellen konzentrierte. Danach war er Leiter des Programms für geriatrische Psychopharmakologie und Leiter der Abteilung für Psychopathologie für Erwachsene am National Institute of Mental Health. Er diente auch als wissenschaftliche Verbindung zur Abteilung Neuropharmakologie der U.S. Food and Drug Administration. Dr. Harris trat anschließend in die Industrie ein und widmete sich mehr als zwei Jahrzehnte der Arzneimittelforschung und -entwicklung bei Unternehmen wie Merck, Cephalon, GlaxoSmithKline und Jazz Pharmaceuticals. Darüber hinaus war er von 2009 bis 2011 als Chief Medical Officer von Tonix und für andere Unternehmen im Frühstadium tätig, darunter Vela Pharmaceuticals und Validus Pharmaceuticals. Dr. Harris war etwa 10 Jahre lang im wissenschaftlichen Beirat von Tonix tätig, bis er zum Executive Vice President, Translational Medicine, von Tonix ernannt wurde.
NEW YORK, May 21, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, posted two posters for the American Society of Clinical Psychopharmacology (ASCP) 2020 Annual Meeting to be held online virtually on May 29-30, 2020. The posters can be found on the Scientific Presentations page of Tonix’s website.
A poster, titled “Pharmacokinetic Results of Dose Proportionality and Food Effect Study of a Sublingual Formulation of Cyclobenzaprine (CBP) HCl (TNX-102 SL)” includes pharmacokinetic (PK) analyses of TNX-102 SL that is being developed as a bedtime treatment for fibromyalgia, posttraumatic stress disorder (PTSD), agitation in Alzheimer’s disease (ADD) and alcohol use disorder (AUD). Sixteen healthy subjects, ages 18-65, were randomized in a 3-way crossover to receive a single dose of TNX-102 SL 2.8 mg fasted, TNX-102 SL 5.6 mg fasted, and TNX-102 SL 5.6 mg fed using a standardized high-fat meal.
A poster, titled “Phase 1 Pharmacokinetic Study of a Once-Daily Formulation of TNX-601 CR (Tianeptine Oxalate Controlled-Release) Tablets,” includes PK analyses of TNX-601 CR which is being developed as a once-daily treatment of major depressive disorder (MDD), PTSD and corticosteroid-induced cognitive dysfunction. In this single-center, open-label, multiple sequential period study, a single cohort of 12 male and female healthy volunteers were administered in successive periods: tianeptine sodium 12.5 mg (Stablon®1), tianeptine oxalate 13.1 mg (TNX-601), tianeptine oxalate CR (TNX-601 CR) 39.4 mg in a fasted state; and TNX-601 CR in a fed state using a standardized high-fat meal.
Dr. Gregory Sullivan, Chief Medical Officer of Tonix said, “Based on the PK results of the study with TNX-102 SL, the rate and extent of absorption of CBP increased in a dose-proportional manner from 2.8 mg to 5.6 mg of CBP. No food effect was observed for CBP for TNX-102 SL 5.6 mg. The absence of a food effect is consistent with transmucosal absorption after sublingual administration, and this is expected to provide more predictable plasma levels compared to oral swallowed forms of CBP.”
Dr. Sullivan continued, “Based on the PK results of the TNX-601 CR study, TNX-601 CR 39.4 mg demonstrated PK appropriate for once-daily dosing with minimal food effect. TNX-601 CR was well-tolerated, without unexpected side effects, and with profiles consistent with the ex-U.S.-marketed sodium salt form of tianeptine dosed three times a day. We believe these findings support further development of TNX-601 CR, the once-daily formulation of tianeptine, in MDD, PTSD and corticosteroid-induced cognitive dysfunction.”
1Stablon is a registered trademark of Les Laboratoires SERVIER (France).
A poster, titled “Pharmacokinetic Results of Dose Proportionality and Food Effect Study of a Sublingual Formulation of Cyclobenzaprine (CBP) HCl (TNX-102 SL)” includes pharmacokinetic (PK) analyses of TNX-102 SL that is being developed as a bedtime treatment for fibromyalgia, posttraumatic stress disorder (PTSD), agitation in Alzheimer’s disease (ADD) and alcohol use disorder (AUD). Sixteen healthy subjects, ages 18-65, were randomized in a 3-way crossover to receive a single dose of TNX-102 SL 2.8 mg fasted, TNX-102 SL 5.6 mg fasted, and TNX-102 SL 5.6 mg fed using a standardized high-fat meal.
A poster, titled “Phase 1 Pharmacokinetic Study of a Once-Daily Formulation of TNX-601 CR (Tianeptine Oxalate Controlled-Release) Tablets,” includes PK analyses of TNX-601 CR which is being developed as a once-daily treatment of major depressive disorder (MDD), PTSD and corticosteroid-induced cognitive dysfunction. In this single-center, open-label, multiple sequential period study, a single cohort of 12 male and female healthy volunteers were administered in successive periods: tianeptine sodium 12.5 mg (Stablon®1), tianeptine oxalate 13.1 mg (TNX-601), tianeptine oxalate CR (TNX-601 CR) 39.4 mg in a fasted state; and TNX-601 CR in a fed state using a standardized high-fat meal.
Dr. Gregory Sullivan, Chief Medical Officer of Tonix said, “Based on the PK results of the study with
Tonix Pharmaceuticals Posted Results from Pharmacokinetic Analyses of TNX-102 SL and TNX-601 CR in Advance of Virtual Poster Presentations at the American Society of Clinical Psychopharmacology
TNX-102 SL, the rate and extent of absorption of CBP increased in a dose-proportional manner from 2.8 mg to 5.6 mg of CBP. No food effect was observed for CBP for TNX-102 SL 5.6 mg. The absence of a food effect is consistent with transmucosal absorption after sublingual administration, and this is expected to provide more predictable plasma levels compared to oral swallowed forms of CBP.”
Dr. Sullivan continued, “Based on the PK results of the TNX-601 CR study, TNX-601 CR 39.4 mg demonstrated PK appropriate for once-daily dosing with minimal food effect. TNX-601 CR was well-tolerated, without unexpected side effects, and with profiles consistent with the ex-U.S.-marketed sodium salt form of tianeptine dosed three times a day. We believe these findings support further development of TNX-601 CR, the once-daily formulation of tianeptine, in MDD, PTSD and corticosteroid-induced cognitive dysfunction.”
1Stablon is a registered trademark of Les Laboratoires SERVIER (France).