IGC Pharma Announces CALMA Phase 2 Trial Expansion with the Addition of Canadian Hamilton Health Sciences
IGC Pharma (NYSE American:IGC) has announced the expansion of its Phase 2 CALMA trial for IGC-AD1 with the addition of a new clinical site at Hamilton Health Sciences (HHS) in Ontario, Canada. The trial expansion aims to accelerate patient enrollment and broaden the company's clinical footprint in developing treatments for Alzheimer's-related agitation.
The CALMA trial at HHS will be led by Dr. Alexandra Papaioannou, Executive Director of HHS' Geras Centre for Aging Research. HHS, one of Canada's leading academic and research hospitals, brings significant expertise in geriatric care and dementia research to the study. The collaboration focuses on developing therapies to address agitation in Alzheimer's patients, a significant challenge affecting patients, families, and caregivers.
IGC Pharma (NYSE American:IGC) ha annunciato l'espansione del suo trial CALMA di Fase 2 per IGC-AD1 con l'aggiunta di un nuovo sito clinico presso Hamilton Health Sciences (HHS) in Ontario, Canada. L'espansione del trial mira ad accelerare l'arruolamento dei pazienti e ad ampliare la presenza clinica dell'azienda nello sviluppo di trattamenti per l'agitazione correlata all'Alzheimer.
Il trial CALMA presso HHS sarà guidato dalla Dr.ssa Alexandra Papaioannou, Direttore Esecutivo del Geras Centre for Aging Research di HHS. HHS, uno dei principali ospedali accademici e di ricerca del Canada, porta un'importante esperienza nella cura geriatrica e nella ricerca sulla demenza nello studio. La collaborazione si concentra sullo sviluppo di terapie per affrontare l'agitazione nei pazienti affetti da Alzheimer, una sfida significativa che colpisce pazienti, famiglie e caregiver.
IGC Pharma (NYSE American:IGC) ha anunciado la expansión de su ensayo CALMA de Fase 2 para IGC-AD1 con la adición de un nuevo sitio clínico en Hamilton Health Sciences (HHS) en Ontario, Canadá. La expansión del ensayo tiene como objetivo acelerar la inscripción de pacientes y ampliar la huella clínica de la empresa en el desarrollo de tratamientos para la agitación relacionada con el Alzheimer.
El ensayo CALMA en HHS será dirigido por la Dra. Alexandra Papaioannou, Directora Ejecutiva del Geras Centre for Aging Research de HHS. HHS, uno de los principales hospitales académicos y de investigación de Canadá, aporta una experiencia significativa en el cuidado geriátrico y la investigación sobre la demencia al estudio. La colaboración se centra en desarrollar terapias para abordar la agitación en pacientes con Alzheimer, un desafío significativo que afecta a pacientes, familias y cuidadores.
IGC Pharma (NYSE American:IGC)는 캐나다 온타리오의 Hamilton Health Sciences (HHS)에 새로운 임상 사이트를 추가하여 IGC-AD1에 대한 2상 CALMA 시험을 확장한다고 발표했습니다. 이번 시험 확장은 환자 등록을 가속화하고 알츠하이머 관련 불안을 위한 치료 개발에서 회사의 임상적 입지를 넓히는 것을 목표로 하고 있습니다.
HHS에서 진행되는 CALMA 시험은 HHS 노화 연구 센터의 전무 이사인 알렉산드라 파파이오안누 박사가 이끌 것입니다. 캐나다의 주요 학술 및 연구 병원 중 하나인 HHS는 연구에 대한 상당한 노인 치료 및 치매 연구 전문성을 제공합니다. 이번 협력은 알츠하이머 환자의 불안을 다루기 위한 치료법 개발에 중점을 두고 있으며, 이는 환자, 가족 및 간병인에게 영향을 미치는 중요한 도전 과제입니다.
IGC Pharma (NYSE American:IGC) a annoncé l'expansion de son essai CALMA de Phase 2 pour IGC-AD1 avec l'ajout d'un nouveau site clinique à Hamilton Health Sciences (HHS) en Ontario, Canada. L'expansion de l'essai vise à accélérer l'inscription des patients et à élargir l'empreinte clinique de l'entreprise dans le développement de traitements pour l'agitation liée à la maladie d'Alzheimer.
L'essai CALMA à HHS sera dirigé par Dr. Alexandra Papaioannou, Directrice Exécutive du Geras Centre for Aging Research de HHS. HHS, l'un des principaux hôpitaux académiques et de recherche du Canada, apporte une expertise significative en soins gériatriques et en recherche sur la démence à l'étude. La collaboration se concentre sur le développement de thérapies pour traiter l'agitation chez les patients atteints d'Alzheimer, un défi important qui touche les patients, les familles et les aidants.
IGC Pharma (NYSE American:IGC) hat die Erweiterung seiner Phase 2 CALMA-Studie für IGC-AD1 mit der Hinzufügung eines neuen klinischen Standorts bei Hamilton Health Sciences (HHS) in Ontario, Kanada, angekündigt. Die Erweiterung der Studie zielt darauf ab, die Patientenrekrutierung zu beschleunigen und den klinischen Fußabdruck des Unternehmens bei der Entwicklung von Behandlungen für die mit Alzheimer verbundenen Unruhe zu erweitern.
Die CALMA-Studie bei HHS wird von Dr. Alexandra Papaioannou, der Geschäftsführerin des Geras Centre for Aging Research von HHS, geleitet. HHS, eines der führenden akademischen und Forschungs-Krankenhäuser Kanadas, bringt bedeutende Expertise in der geriatrischen Versorgung und der Demenzforschung in die Studie ein. Die Zusammenarbeit konzentriert sich auf die Entwicklung von Therapien zur Behandlung von Unruhe bei Alzheimer-Patienten, eine bedeutende Herausforderung, die Patienten, Familien und Pflegekräfte betrifft.
- Expansion to prestigious Canadian research hospital broadens clinical trial reach
- Partnership with leading geriatric and dementia research expertise
- Potential acceleration of patient enrollment for Phase 2 trial
- None.
POTOMAC, MD / ACCESS Newswire / March 20, 2025 / IGC Pharma, Inc. ("IGC", or the "Company") (NYSE American:IGC) today announced the expansion of its ongoing Phase 2 CALMA trial for IGC-AD1 with the addition of a new clinical site at Hamilton Health Sciences (HHS) in Ontario, Canada. This expansion marks a key milestone in IGC Pharma's strategy to advance IGC-AD1 toward commercialization, accelerating patient enrollment and expanding the Company's clinical footprint.
Hamilton Health Sciences is one of Canada's leading academic and research hospitals. The CALMA trial at HHS will be led by Dr. Alexandra Papaioannou, a distinguished geriatrician and Executive Director of HHS' Geras Centre for Aging Research, whose expertise in aging, frailty, and dementia will play a critical role in the trial's success.
"We are excited to welcome Hamilton Health Sciences as a site in the CALMA trial," said Ram Mukunda, CEO of IGC Pharma. "Their world-class expertise in geriatric care and dementia research aligns with our mission to develop safe and effective therapies for Alzheimer's patients. Expanding the trial to this prestigious institution not only strengthens our study but also enhances patient access, accelerating our efforts to bring IGC-AD1 to market and deliver value for shareholders."
"Agitation is a significant challenge for Alzheimer's patients, their families, and caregivers," said Dr. Alexandra Papaioannou. "By participating in the CALMA trial, we aim to contribute to the development of urgently needed therapies to improve the quality of life for individuals living with this disease. We look forward to advancing research that has the potential to make a meaningful impact."
About IGC-AD1 and the CALMA Trial
IGC-AD1 is IGC Pharma's investigational cannabinoid-based therapy currently in a Phase 2 multicenter, double-blind, randomized, placebo-controlled study (CALMA) evaluating its safety and efficacy for treating agitation in Alzheimer's dementia. Agitation affects up to
With multiple trial sites now active across the U.S. and Canada, IGC Pharma remains focused on accelerating patient enrollment and generating data that could support regulatory approval and commercialization of IGC-AD1.
For more information on the CALMA trial, visit: ClinicalTrials.gov.
About IGC Pharma (dba IGC):
IGC Pharma is an AI-powered, clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer's disease and transforming patient care with fast-acting, safe, and effective solutions. Our portfolio includes the TGR family, including TGR-63, which targets amyloid plaques, a hallmark of Alzheimer's. The IGC-C and IGC-M platforms are advancing in preclinical studies, focusing on metabolic disorders, tau proteins, early plaque formation, and multiple disease hallmarks. Our lead therapeutic candidate, IGC-AD1, is a cannabinoid-based treatment currently in a Phase 2 trial for agitation in dementia ("CALMA") associated with Alzheimer's (clinicaltrials.gov, IGC Pharma Phase II). Interim data for IGC-AD1 demonstrated that it has the potential to transform patient care by offering faster-acting and more effective relief compared to traditional medications. Additionally, our AI models are designed to predict potential biomarkers for the early detection of Alzheimer's, optimize clinical trials, and predict receptor affinity, among others. With 32 patent filings and a commitment to innovation, IGC Pharma is dedicated to advancing pharmaceutical treatments and improving the lives of those affected by Alzheimer's and related conditions. The Company operates a wellness brand offering scientifically formulated products under the brand Holiby™ and as white-labeled formulations.
Forward-Looking Statements
This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 24, 2024, and on Form 10-Qs filed with the SEC on August 7, 2024, November 12, 2024, and February 14, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.
Contact Information
Rosalyn Christian
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
View the original press release on ACCESS Newswire
FAQ
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