PURPOSEWe have evaluated in vitro the effects of using plasma (group A) or PAS-2 (group B) in storing platelets, regarding as well the type of container (conventional polyolefin--PL732--or new oxygen permeable platelet containers--PL2410, Compoflex--), on the metabolism of platelet concentrates--PC--from pools of five buffy coats.MATERIAL AND METHODS87, A and B pools of PCs collected in two types of bags were studied. The samples were taken on days 2, 5 and 7, and cell counts, pH, glucose, platelet activation (% CD62) and aggregation response were measured.RESULTSIn group A, when we compared the two types of bags, we observed a difference (p < 0.01) in values of pH and glucose on day 5. These values were more advantageous in new oxygen permeable platelet containers. The rest of the parameters analysed didn't show significant differences. When we compared the PL-2410 containers from groups A and B, we found a lower level of glucose (p < 0.01) in group B, although the levels of glucose in this group on days 5 and 7 of storage were sufficient to support the platelet metabolism.CONCLUSIONSThe use of new oxygen permeable polyolefin containers and additive solutions, PAS-2, allows us to obtain pools of PC with suitable metabolic parameters during storage.

1996-11-12·Transfusion

More on the comparison of Plasma‐Lyte A and PAS 2 as platelet additive solutions

Letter

作者: Virginia S. Turner ; Susan G. Mitchell ; Robert J. Hawker

1996-07-01·Vox Sanguinis4区 · 医学

Platelets Stored in a Glucose‐Free Additive Solution or in Autologous Plasma – An Ultrastructural and Morphometric Evaluation

4区 · 医学

Article

作者: Mirko Josch ; Harald Klüter ; Matthias H.F. Klinger

AbstractWe evaluated a new glucose‐free citrate‐acetate‐NaCl platelet additive solution (PAS 2). In series I, platelet concentrates (PC) were prepared by apheresis and subsequently stored either in plasma (n =16) or in PAS 2 (n =15). In series II, PCs were prepared from pools of four buffy coats (BC) and stored in plasma (n =12) or in PAS 2 (n =11). By means of ultrastructural morphometry, the volume fractions of α‐granules, the open canalicular system (OCS) and the fraction of storage granules secreted into the OCS were analyzed during storage for up to 8 days. Additionally, we determined pH, glucose, lactate, pCO2, HCO3–, lactate dehydrogenase and platelet factor 4. Apheresis platelets stored in plasma showed no changes in their contents of α‐granules and in the fractions of the OCS. In contrast, apheresis platelets stored in PAS 2 displayed a decrease of their relative volume fraction of α‐granules from 9.1±1% on day 1 to 3.7±0.9% on day 5. The fraction of the OCS increased from 7.4±0.8% on day 1 to 17.1±1.4% on day 3. On day 8, 93±9% of all platelets were lysed. Levels of glucose were significantly lower in these preparations and after day 3 glucose consumption decreased to zero. Among PC derived from pooled BC, differences between storage in PAS 2 or plasma were less striking. Only the fraction of α‐granules secreted into the OCS was significantly greater in BC derived PC stored in PAS 2 on all days. These PCs stored in PAS 2 had a higher plasma carryover (30%) in comparison to apheresis PC stored in PAS 2 (10%). We conclude that plasma is superior to PAS 2 for storage of both apheresis and buffy coat platelets. For preservation of the structural integrity of platelets, the use of PAS 2 requires a minimum of 30% plasma carryover.

项与 PAS002 相关的新闻（医药）

2024-11-13

·PRNewswire

75+ Key Companies Charting New Frontiers in Multiple Sclerosis Therapeutic Space | DelveInsight

Multiple sclerosis (MS) is a chronic neurological disorder affecting the central nervous system (CNS), particularly the brain, spinal cord, and optic nerves. Continuous research has led to new drug developments, particularly disease-modifying therapies (DMTs) that slow MS progression. Monoclonal antibodies, oral therapies, and infusion treatments are among the most promising options and drives the multiple sclerosis market. LAS VEGAS, Nov. 13, 2024 /PRNewswire/ -- DelveInsight's ' Multiple Sclerosis Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline multiple sclerosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the multiple sclerosis pipeline domain. Key Takeaways from the Multiple Sclerosis Pipeline Report DelveInsight's multiple sclerosis pipeline report depicts a robust space with 75+ active players working to develop 80+ pipeline therapies for multiple sclerosis treatment. Key multiple sclerosis companies such as Mapi Pharma, Novartis, Immunic, Biocad, Apimeds, Genentech (Roche), AB Science, Celltrion, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, BrainStorm Cell Therapeutics, NeuroSense Therapeutics, Denali Therapeutics Inc., Sanofi, MediciNova, Biogen, Tiziana Life Sciences, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Eli Lilly and Company, Axsome Therapeutics, Accure therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio-Technology Co., Ltd., ImCyse, Lucid Psycheceuticals, Immune Response BioPharma, Guangzhou Lupeng Pharmaceutical, Kyowa Kirin, Nura Bio, Bristol-Myers Squibb, ImStem Biotechnology, Hoffmann-La Roche, LAPIX Therapeutics, Motric Bio, Immunophage Biotech, NervGen, FibroBiologics, Kyverna Therapeutics, GlaxoSmithKline, PolTREG, Cyxone, Biohaven Pharmaceuticals, HuniLife Biotechnology, GlobeStar Therapeutics, Anokion, Medsenic, ZyVersa Therapeutics, Alumis Inc., Axoltis Pharma, Barricade Therapeutics, BioNxt Solutions, Eikonoklastes Therapeutics, 4D Pharma, Gossamer Bio, Pasithea Therapeutics, Synaptogenix, Monte Rosa Therapeutics, Immix Biopharma, f5 Therapeutics, Autobahn Therapeutics, Biosenic, Polpharma Biologics, Find Therapeutics, TeraImmun, AptaTargets, Trethera, Aditxt, SetPoint Medical, Sarepta Therapeutics, Nucleome Therapeutics, Vaccinex Inc., and others are evaluating new multiple sclerosis drugs to improve the treatment landscape. Promising multiple sclerosis pipeline therapies such as GA Depot, Remibrutinib, Tolebrutinib, IMU 838, BCD-132, Apitox, Fenebrutinib, SAR 441344, CT-P53, CNM-Au8, Orelabrutinib, Vafidemstat, Temelimab, Elezanumab, NurOwn (MSC-NTF cells), PrimeC, SAR4433820, Ibudilast, BIIB091, Foralumab, ATL1102, RC18, ATA188, PIPE-307, Pirtobrutinib, LY3541860, Solriamfetol, Act-01, SCM-010, UMSC01, IMCY-0141, Lucid-MS, NeuroVax, LP-168, NB-4746, CC-97540, IMS-001, RO7121932, BMS-986196, LPX-TI641, MTR-601, IPG-11406, IPG-1094, NVG-291, CYMS-101, KYV-101, PIPE-791, GSK 3888130B, PTG-007, T 20K, BHV-8000, HuL001, Amethyst™, ANK 700, Arscimed, A-005, NX210c, Research programme: CAR-TREG, TASIN-1, Cladribine ODF, ET-101, MRx0002, GB7208, PAS-002, Bryostatin-1, MRT-6160, NXC-201, Research Program: Cytokine reduction, ABX-002, Arsenic trioxide, LL-341070, PB018, FTX 101, TI-235, TRE 515, NT-0007, NT-0002, NVG300, and others are under different phases of multiple sclerosis clinical trials. In October 2024, Immunic, Inc. reported favorable results from the non-binding interim futility analysis of its Phase 3 ENSURE trial, which is evaluating its lead candidate, vidofludimus calcium (IMU-838), a nuclear receptor-related 1 (Nurr1) activator, for the treatment of relapsing multiple sclerosis (RMS). In October 2024, Immunic, Inc. announced a positive outcome of the non-binding, interim futility analysis of its Phase III ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned. In September 2024, Roche, secured FDA approval for an injectable form of its blockbuster multiple sclerosis treatment, Ocrevus, reducing patient treatment time and potentially helping the company stay ahead of increasing competition. In September 2024, Sanofi announced the outcomes of Phase III clinical trials of its investigational oral brain-penetrant BTK inhibitor, tolebrutinib, aimed at treating multiple sclerosis (MS). These studies, namely HERCULES, GEMINI 1, and GEMINI 2, have provided mixed results, with the HERCULES trial meeting its primary endpoint while the GEMINI trials did not. The HERCULES study focused on the efficacy and safety of tolebrutinib in individuals with non-relapsing secondary progressive MS (nrSPMS) compared to a placebo. In August 2024, Abata Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ABA-101 for the treatment of patients with progressive multiple sclerosis (MS). The FDA recently cleared ABA-101's Investigational New Drug (IND) application, and initiation of a first-in-human (FIH) Phase I study is imminent. In August 2024, TG Therapeutics announced that the FDA has cleared an investigational new drug (IND) application submitted by TG Therapeutics for azercabtagene zapreleucel (azer-cel), an investigational allogeneic chimeric antigen receptor T-cell (CAR-T) therapy, for a phase 1 clinical trial in patients with progressive multiple sclerosis (MS). In January 2024, Kyverna Therapeutics, Inc. announced it received fast-track designation by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of multiple sclerosis (MS). Request a sample and discover the recent advances in multiple sclerosis treatment drugs @ Multiple Sclerosis Pipeline Report The multiple sclerosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage multiple sclerosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the multiple sclerosis clinical trial landscape. Multiple Sclerosis Overview Multiple sclerosis is a chronic autoimmune disorder that affects the central nervous system, leading to the deterioration or permanent damage of myelin, the protective sheath surrounding nerve fibers. While the exact cause of multiple sclerosis remains unclear, it is believed to involve a combination of genetic predisposition, environmental factors, and possibly viral infections. Common symptoms of multiple sclerosis include fatigue, difficulty walking, numbness or tingling in the limbs, muscle weakness, and vision problems, which can vary significantly among individuals and may evolve over time. Diagnosis typically involves a combination of neurological examinations, magnetic resonance imaging (MRI) to detect lesions in the brain and spinal cord, and sometimes lumbar puncture to analyze cerebrospinal fluid for inflammatory markers. While there is no cure for multiple sclerosis, treatment options aim to manage symptoms, reduce the frequency and severity of relapses, and slow disease progression. This may include disease-modifying therapies (DMTs), corticosteroids for acute exacerbations, and symptomatic treatments such as physical therapy, pain management, and lifestyle modifications. Early diagnosis and a tailored treatment plan are crucial for improving the quality of life for those living with multiple sclerosis. Find out more about multiple sclerosis treatment drugs @ Drugs for Multiple Sclerosis Treatment A snapshot of the Multiple Sclerosis Pipeline Drugs mentioned in the report: Learn more about the emerging multiple sclerosis pipeline therapies @ Multiple Sclerosis Clinical Trials Multiple Sclerosis Therapeutics Assessment The multiple sclerosis pipeline report proffers an integral view of the multiple sclerosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Multiple Sclerosis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Immunomodulators, MHC class II gene modulators, Agammaglobulinaemia tyrosine kinase inhibitors, Dihydroorotate dehydrogenase inhibitors, Nuclear receptor subfamily 4 group A member 2 agonists, CD20 antigen inhibitors, Energy metabolism stimulants; Immunomodulators, Lysine-specific demethylase 1 inhibitors, Monoamine oxidase B inhibitors, Protein-arginine deiminase inhibitors, Immunostimulants Key Multiple Sclerosis Companies: Mapi Pharma, Novartis, Immunic, Biocad, Apimeds, Genentech (Roche), AB Science, Celltrion, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, BrainStorm Cell Therapeutics, NeuroSense Therapeutics, Denali Therapeutics Inc., Sanofi, MediciNova, Biogen, Tiziana Life Sciences, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Eli Lilly and Company, Axsome Therapeutics, Accure therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio-Technology Co., Ltd., ImCyse, Lucid Psycheceuticals, Immune Response BioPharma, Guangzhou Lupeng Pharmaceutical, Kyowa Kirin, Nura Bio, Bristol-Myers Squibb, ImStem Biotechnology, Hoffmann-La Roche, LAPIX Therapeutics, Motric Bio, Immunophage Biotech, NervGen, FibroBiologics, Kyverna Therapeutics, GlaxoSmithKline, PolTREG, Cyxone, Biohaven Pharmaceuticals, HuniLife Biotechnology, GlobeStar Therapeutics, Anokion, Medsenic, ZyVersa Therapeutics, Alumis Inc., Axoltis Pharma, Barricade Therapeutics, BioNxt Solutions, Eikonoklastes Therapeutics, 4D Pharma, Gossamer Bio, Pasithea Therapeutics, Synaptogenix, Monte Rosa Therapeutics, Immix Biopharma, f5 Therapeutics, Autobahn Therapeutics, Biosenic, Polpharma Biologics, Find Therapeutics, TeraImmun, AptaTargets, Trethera, Aditxt, SetPoint Medical, Sarepta Therapeutics, Nucleome Therapeutics, Vaccinex Inc., and others are evaluating new multiple sclerosis drugs to improve the treatment landscape. Key Multiple Sclerosis Pipeline Therapies:GA Depot, Remibrutinib, Tolebrutinib, IMU 838, BCD-132, Apitox, Fenebrutinib, SAR 441344, CT-P53, CNM-Au8, Orelabrutinib, Vafidemstat, Temelimab, Elezanumab, NurOwn (MSC-NTF cells), PrimeC, SAR4433820, Ibudilast, BIIB091, Foralumab, ATL1102, RC18, ATA188, PIPE-307, Pirtobrutinib, LY3541860, Solriamfetol, Act-01, SCM-010, UMSC01, IMCY-0141, Lucid-MS, NeuroVax, LP-168, NB-4746, CC-97540, IMS-001, RO7121932, BMS-986196, LPX-TI641, MTR-601, IPG-11406, IPG-1094, NVG-291, CYMS-101, KYV-101, PIPE-791, GSK 3888130B, PTG-007, T 20K, BHV-8000, HuL001, Amethyst™, ANK 700, Arscimed, A-005, NX210c, Research programme: CAR-TREG, TASIN-1, Cladribine ODF, ET-101, MRx0002, GB7208, PAS-002, Bryostatin-1, MRT-6160, NXC-201, Research Program: Cytokine reduction, ABX-002, Arsenic trioxide, LL-341070, PB018, FTX 101, TI-235, TRE 515, NT-0007, NT-0002, NVG300, and others are under different phases of multiple sclerosis clinical trials. Dive deep into rich insights for new drugs for multiple sclerosis treatment, visit @ Multiple Sclerosis Drugs Table of Contents For further information on the multiple sclerosis pipeline therapeutics, reach out @ Multiple Sclerosis Treatment Drugs Related Reports Multiple Sclerosis Market Multiple Sclerosis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key multiple sclerosis companies including Immune Response BioPharma, Inc., Clene Nanomedicine, Genzyme, ImStem Biotechnology, Rho, Inc., Bristol-Myers Squibb, TG Therapeutics, Inc., Hoffmann-La Roche, Atara Biotherapeutics, Immunic AG, Celgene, Anokion SA, Sanofi, Actelion, Biogen, Supernus Pharmaceuticals, Inc., GeNeuro SA, HuniLife Biotechnology, Inc., Emerald Health Pharmaceuticals, RemeGen Co., Ltd., Antisense Therapeutics, Biocad, AB Science, Genentech, Novartis, Pipeline Therapeutics, ASLAN Pharmaceuticals, GlaxoSmithKline, Lucid Psycheceuticals, Voronoi, Hanmi Pharmaceutical, Mapi Pharma, f5 Therapeutics, Autobahn Therapeutics, AstraZeneca, ZyVersa Therapeutics, RedHill Biopharma, Gossamer Bio, Sarepta Therapeutics, BrainStorm Cell Limited, CytoDyn, Pear Therapeutics, Solstice Neurosciences, ProJenX, among others. Multiple Sclerosis Epidemiology Forecast Multiple Sclerosis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted multiple sclerosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Relapsing Multiple Sclerosis Pipeline Relapsing Multiple Sclerosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key relapsing multiple sclerosis companies, including ASLAN Pharmaceuticals, GlaxoSmithKline, Lucid Psycheceuticals, Voronoi, Hanmi Pharmaceutical, among others. Relapsing-Remitting Multiple Sclerosis Pipeline Relapsing-Remitting Multiple Sclerosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RRMS companies, including TG Therapeutics, Novartis, Sanofi, Cinnagen, Polpharma Biologics, Immunic, Mapi Pharma, Biocad, Apimeds, Genentech (Roche), Merck, Immune Response BioPharma, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, Emerald Health Pharmaceuticals, GlaxoSmithKline, RedHill Biopharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期临床结果快速通道细胞疗法免疫疗法

2023-02-23

·BioSpace

Pasithea Therapeutics Chairman, Prof. Lawrence Steinman to Deliver Dr. Kenneth P. Johnson Lecture at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS)

PALO ALTO, Calif. and MIAMI, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, today announced that Lawrence Steinman, Pasithea’s Chairman and National Academy of Sciences Professor, will deliver the Dr. Kenneth P. Johnson lecture at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) on February 23 in San Diego, California. The ACTRIMS Forum is a translational science meeting focusing on scientific discoveries made in multiple sclerosis (MS) to advance the understanding of research and clinical care of patients with MS. The lecture allows attendees an opportunity to hear from a prestigious researcher selected for their contributions to multiple sclerosis. Prof. Steinman’s research on the link between Epstein-Barr virus and multiple sclerosis was a runner-up for Science Magazine’s 2022 Breakthrough of the Year. About PAS-002 The Company’s PAS-002 discovery program aims to develop a proprietary engineered DNA plasmid vaccine to tolerize the immune system to GlialCAM for the treatment of multiple sclerosis. GlialCAM, a CNS protein, found in the brain’s white matter is attacked in MS. GlialCAM shares a component of its structure that mimics an identical component of Epstein-Barr virus nuclear antigen 1 (EBNA-1), which plays a critical role in triggering MS. About Multiple Sclerosis Multiple sclerosis (“MS”) is a chronic and potentially disabling autoimmune disease, and the most common neurodegenerative disease of the central nervous system in young adults. The pathological hallmark of MS is the formation of demyelinating lesions in the brain and spinal cord, with the immune system attacking the myelin sheath that normally protects nerve fibers in the brain, spinal cord, and optic nerve. There are now 2.8 million people worldwide who have MS, and every five minutes, someone, somewhere in the world is diagnosed with this disorder. While there is no way to predict with any certainty how an individual’s disease will progress, four basic MS disease courses (also called types or phenotypes) have been defined: clinically isolated syndrome, relapsing remitting, secondary progressive and primary progressive. The most common affecting around 85 per cent of everyone diagnosed with MS is relapsing remitting MS (RRMS). It means that symptoms appear (a relapse), and then fade away, either partially or completely (remitting). About Pasithea Therapeutics Corp. Pasithea Therapeutics is a biotechnology company primarily focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders. We leverage our expertise in the fields of neuroscience, medicinal chemistry, and translational medicine to develop new molecular entities that target the pathophysiology underlying such diseases with the goal of bringing life-changing therapies to patients. Forward Looking Statements This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law. Company Contact Dr. Tiago Reis Marques Chief Executive Officer Email: tiago@pasithea.com

疫苗

2023-01-18

·BioSpace

Pasithea Therapeutics Signs CMC Development and Manufacturing Agreement for the Production of PAS-004

-- Plans to Initiate a Phase 1 Clinical Trial in the U.S. for Neurofibromatosis Type 1 (NF1) in 2H 2023 -- MIAMI BEACH, Fla., Jan. 18, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research and development of innovative treatments for Central Nervous System (CNS) disorders, today announced its contract with WuXi STA, a subsidiary of WuXi AppTec, to manufacture the active pharmaceutical ingredient (“API”) for Pasithea’s macrocyclic, next-generation MEK Inhibitor, PAS-004 (formerly CIP-137401). After the completion of the pre-clinical testing and animal toxicology studies, GMP manufacturing is our final major requirement to support the Company’s Investigational New Drug (“IND”) application with the U.S. Federal Drug Association (“FDA”), which is expected in the second half of 2023. WuXi STA is recognized as an industry leader in “end-to-end” chemistry, manufacturing, and controls (CMC) services, for both API and finished dosage forms, with extensive expertise and track record for meeting global quality standards. “We are delighted to be working with WuXi STA, one of the largest and most well-respected Contract, Development, and Manufacturing Organizations (CDMOs) in the world. We remain on track with PAS-004 development and look forward to our IND submission followed by the initiation of our Phase 1 clinical trial,” commented Pasithea CEO, Dr. Tiago Reis Marques. “WuXi STA has a proven track record of manufacturing success to FDA standards and we believe that their high-quality capabilities will support progression of our drug candidate into the clinic. PAS-004 has already received orphan drug designation from the FDA for neurofibromatosis 1, and we plan to start our phase 1 clinical trial in the second half of 2023,” stated Dr. Graeme Currie, Chief Development Officer of Pasithea. About PAS-004 PAS-004 is a small molecule allosteric inhibitor of MEK 1/2 in the Ras-Raf-MEK-ERK signaling pathway, which plays critical roles in the regulation of diverse cellular activities, including cell proliferation, survival, differentiation, and motility. Existing MEK inhibitors are marketed and being tested for a range of diseases providing evidence for the value of regulating MEK as a drug target, however, they suffer from limitations. Unlike other MEK inhibitors, PAS-004 is macrocyclic, which displays improved drug-like properties, such as optimal pharmacokinetic, safety (tolerability), and potency profiles that offer promising potential benefits over other MEK inhibitors. Macrocycles are large cyclic molecules that can bring increased potency, metabolic stability, and oral bioavailability. Cyclization offers rigidity for stronger binding with drug target receptors. PAS-004 was developed to limit metabolic liabilities and overcome the limited exposure and stability of known MEK inhibitors. PAS-004 has displayed efficacy in various animal models and has completed pre-clinical testing and animal toxicology studies to support an IND application with the FDA. PAS-004 received orphan-drug designation from the FDA for the treatment of NF1. About WuXi STA WuXi STA (stapharma.com), a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations across Asia, North America, and Europe. As a premier Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate. For more information, please visit: and follow us on LinkedIn. About Pasithea Therapeutics Corp. Pasithea Therapeutics is a biotechnology company primarily focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders. With an experienced team of experts in the fields of neuroscience and psychopharmacology, Pasithea is developing new molecular entities for the treatment of neurological disorders, including Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS), Neurofibromatosis type 1 (NF1) and Noonan syndrome. Forward Looking Statements This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law. Company Contact Dr. Tiago Reis Marques Chief Executive Officer Email: tiago@pasithea.com

孤儿药临床1期引进/卖出

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