Chronic Limb-Threatening Ischemia

MELBOURNE, Australia, March 4, 2024 /PRNewswire/ -- Cynata Therapeutics Limited (ASX: " CYP", "Cynata", or the "Company"), a clinical-stage biotechnology company specialising in cell therapeutics, confirms that the first patient has been enrolled and treated in its Phase 2 clinical trial of CYP-001 in high-risk acute graft versus host disease (aGvHD). CYP-001 is Cynata's Cymerus™ off-the-shelf iPSC[1]-derived MSC[2] product candidate for intravenous infusion, which previously generated very encouraging safety and efficacy results in a Phase 1 clinical trial in steroid-resistant aGvHD.[3] The US FDA has cleared an Investigational New Drug (IND) application for CYP-001 and granted the product Orphan Drug Designation[4] for the treatment of aGvHD. aGvHD is a potentially life-threatening complication of bone marrow transplants or similar procedures. It arises when immune cells in the transplant (the graft) attack the recipient's tissues (the host) as "foreign". In this trial, CYP-001 is being investigated as a potential immune modulating treatment for aGvHD. This global Phase 2 trial aims to enrol approximately 60 patients with high-risk aGvHD, who will be randomised to receive either steroids plus CYP-001, or steroids plus placebo. Additional details on the trial may be found at clinicaltrials.gov using identifier NCT05643638. The trial has been approved to commence in Australia, the USA and Turkey, and numerous clinical centres across those jurisdictions are now open for recruitment. The first patient was enrolled in the USA. Dr Kilian Kelly, Cynata's Chief Executive Officer, said: "The treatment of the first patient in this Phase 2 trial marks a milestone moment in the clinical development journey of CYP‑001 for aGVHD. We are continuing to open additional clinical centres, and we anticipate completion of enrolment by the end of this calendar year, with primary results available in the second half of 2025." About Cynata Therapeutics (ASX: CYP) Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors. Cynata's lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. A Phase 2 clinical trial in GvHD under a cleared US FDA IND, as well as trials of Cymerus products in osteoarthritis (Phase 3) and diabetic foot ulcers (DFU) are currently ongoing, while a trial in renal transplant is expected to commence in the near future. In addition, Cynata has also demonstrated utility of its Cymerus technology in preclinical models of numerous diseases, including critical limb ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome. Cynata Therapeutics encourages all current investors to go paperless by registering their details with the designated registry service provider, Automic Group. SOURCE Cynata Therapeutics

DUBLIN, March 1, 2024 /PRNewswire/ -- The "Peripheral Arterial Disease (PAD) Therapeutics: Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. Global Peripheral Arterial Disease (PAD) Therapeutics Market to Reach $7 Billion by 2030 The global market for Peripheral Arterial Disease (PAD) Therapeutics estimated at US$4 Billion in the year 2022, is projected to reach a revised size of US$7 Billion by 2030, growing at a CAGR of 7.1% over the analysis period 2022-2030. Peripheral Stents, one of the segments analyzed in the report, is projected to record a 6.9% CAGR and reach US$1.7 Billion by the end of the analysis period. Taking into account the ongoing post pandemic recovery, growth in the Peripheral Angioplasty Balloons segment is readjusted to a revised 6.4% CAGR for the next 8-year period. The U.S. Market is Estimated at $1.2 Billion, While China is Forecast to Grow at 6.7% CAGR The Peripheral Arterial Disease (PAD) Therapeutics market in the U.S. is estimated at US$1.2 Billion in the year 2022. China, the world's second largest economy, is forecast to reach a projected market size of US$1.2 Billion by the year 2030 trailing a CAGR of 6.7% over the analysis period 2022 to 2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 6.3% and 5.9% respectively over the 2022-2030 period. Within Europe, Germany is forecast to grow at approximately 5.5% CAGR. MARKET OVERVIEW Influencer Market Insights World Market Trajectories PAD - A Prelude Recent Market Activity PAD Statistics Critical Limb Ischemia - An Insight High Costs - A Cause of Concern Peripheral Arterial Disease (PAD) Therapeutics - Global Key Competitors Percentage Market Share in 2022 (E) Impact of Covid-19 and a Looming Global Recession Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2022 (E) MARKET TRENDS & DRIVERS Aging - A Key Driver High Diabetes Incidence Worldwide: Key Market Opportunity for PAD Therapeutics FOCUS ON SELECT PLAYERS (Total 32 Featured) AstraZeneca Plc. (UK) Bayer HealthCare Pharmaceuticals (Germany) Bristol-Myers Squibb Company (US) Merck & Co., Inc. (US) Proteon Therapeutics, Inc. (US) Sanofi S.A. (France) Symic Bio, Inc. (US) TheraVasc Inc. (US) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

TED-A9 is high-purity midbrain dopaminergic progenitor cells derived from human embryonic stem cells (hESCs) under rigorous GMP conditions Investigational cell therapy with TED-A9 completed transplantation of 12 participants in a Phase 1/2a trial SEOUL, South Korea--(BUSINESS WIRE)-- S.BIOMEDICS Co., Ltd. (KOSDAQ: 304360) announced that it has successfully completed the brain transplant of TED-A9 (hESC-derived dopaminergic progenitors) for Phase 1/2a study for treating Parkinson's disease. The clinical trial was conducted on 12 participants who have been diagnosed with Parkinson's disease for more than 5 years and exhibited motor complications such as drug wearing-off, freezing of gait or dyskinesia. The participant’s age was between 50 and 75 years old. TED-A9 were administered to 6 participants in the low-dose group (3.15 million cells) and to another 6 participants in the high-dose group (6.30 million cells). “The first administration began last year and completed the transplantation of 12 patients in February of this year without any special problems,” said Prof. Dong-Wook Kim at Yonsei University College of Medicine, developer of TED-A9 and CTO of S.BIOMEDICS. The primary objective of the Phase 1/2a trial is to assess the safety and exploratory efficacy of TED-A9 transplantation for two years post-transplant. Safety will be monitored for additional 3 years, making it a total 5 years. An initial cohort of three patients was enrolled at a low dose to assess initial safety, including dose-limiting toxicity (DLT) evaluation, over up to 3 months post-transplantation. There were no safety concerns within this timeframe. Thus, an additional 3 patients were enrolled at a high dose for evaluation over another 3 months post-transplantation. As no safety issues arose during this extended period, the clinical trial continued by adding three further patients to each of the low-dose and high-dose groups, totaling 12 patients. “The transplantation process targeted three segments of the putamen; the anterior, middle, and posterior sections, with three tracks per each putamen. Bilateral putamina received cell transplantation in a single surgical procedure, with cells injected at three points within each track,” Prof. Dong-Wook Kim explained. The clinical trial was conducted at Severance Hospital led by Prof. Jin-Woo Chang, a neurosurgeon and the principal investigator of the transplant and Prof. Phil-Hyu Lee, a neurologist. According to Prof. Chang, none of the 12 Parkinson's disease participants had any side effects, complications, or unusual adverse reactions following the transplantation of TED-A9. The development of TED-A9 has been led by Prof. Dong-Wook Kim. TED-A9 is ventral midbrain-specific dopaminergic progenitors derived from hESCs by exclusively utilizing small molecules. TED-A9 represents a significant advancement in the field, offering highly purified dopamine cells derived from hESCs. S.BIOMEDICS believes that when surgically transplanted into the brain, these high-purity dopamine cells, replacing dead cells, have the potential to restore the motor function of patients with Parkinson’s disease. “At S.BIOMEDICS, we are committed to developing data-driven medicine for Parkinson’s disease,” said Prof. Dong-Wook Kim. “We have developed a fundamental therapeutic mechanism that directly replaces dopaminergic neurons lost in patients with Parkinson's disease. TED-A9 could represent a fundamental treatment that surpasses current therapies, which only temporarily alleviate the symptoms of Parkinson’s disease,” he added. About S.BIOMEDICS Established in 2005, S.BIOMEDICS is at the forefront of stem cell therapy, focusing on regenerative medicine powered by data-driven biology. Based on two core platform technologies, S.BIOMEDICS currently develops seven cell therapy programs, targeting non-curable diseases. Its leading programs are under clinical stage accelerating the journey of cell medicine as shown below: TED-A9: Ventral midbrain-specific dopaminergic progenitor cells derived from hESCs for Parkinson’s disease (Phase 1/2a) TED-N: PSA-NCAM-positive neural progenitor cells derived from hESCs for spinal cord injury (Phase 1/2a) FECS-AD: 3D MSC spheroids for critical limb ischemia (Phase 1/2a) For more information about S.BIOMEDICS, visit . S.BIOMEDICS is listed on the Korea Exchange (KOSDAQ: 304360) and is also the founder and controller of S.THEPHARM, a corporation specializing in anti-aging products such as HA-Filler. More Information about the Phase 1/2a trial is available at ClinicalTrials.gov (NCT05887466).