IGC Pharma Expands CALMA Phase 2 Trial with Site at Lynn Health Science Institute in Oklahoma City
IGC Pharma (NYSE American:IGC) has expanded its Phase 2 clinical trial for IGC-AD1, a drug candidate targeting agitation in Alzheimer's disease patients, by adding a new site at the Lynn Health Science Institute (LHSI) in Oklahoma City.
The CALMA trial, designed as a randomized, double-blind, placebo-controlled study, will be led by Principal Investigator Dr. Carl Griffin at the new site. The trial aims to evaluate IGC-AD1's safety and efficacy in addressing one of Alzheimer's most challenging symptoms - agitation, which often leads to earlier institutionalization and increased caregiver stress.
IGC Pharma (NYSE American:IGC) ha ampliato lo studio di Fase 2 su IGC-AD1, candidato farmaco per l'agitazione nei pazienti con Alzheimer, aggiungendo un nuovo centro presso il Lynn Health Science Institute (LHSI) a Oklahoma City.
Il trial CALMA, progettato come uno studio randomizzato, in doppio cieco e controllato con placebo, sarà condotto nel nuovo sito dal ricercatore principale, il dott. Carl Griffin. L'obiettivo è valutare la sicurezza e l'efficacia di IGC-AD1 nel trattare una delle manifestazioni più difficili dell'Alzheimer: l'agitazione, che spesso anticipa l'istituzionalizzazione e aumenta lo stress dei caregiver.
IGC Pharma (NYSE American:IGC) ha ampliado su ensayo de Fase 2 para IGC-AD1, un candidato farmacológico dirigido a la agitación en pacientes con Alzheimer, añadiendo un nuevo centro en el Lynn Health Science Institute (LHSI) en Oklahoma City.
El ensayo CALMA, diseñado como un estudio aleatorizado, doble ciego y controlado con placebo, será liderado en este sitio por el investigador principal, el Dr. Carl Griffin. El estudio pretende evaluar la seguridad y eficacia de IGC-AD1 para abordar uno de los síntomas más complejos del Alzheimer: la agitación, que con frecuencia provoca institucionalización temprana y aumenta la carga sobre los cuidadores.
IGC Pharma (NYSE American:IGC)는 알츠하이머 환자의 초조·난동을 표적으로 하는 약물 후보 IGC-AD1의 2상 임상시험을 오클라호마시티의 Lynn Health Science Institute (LHSI)에 신규 기관을 추가해 확대했습니다.
CALMA 시험은 무작위 배정, 이중맹검, 위약 대조 방식으로 설계되었으며, 신규 기관에서는 책임연구자 칼 그리핀 박사가 연구를 이끕니다. 이 연구는 조기 시설 입소와 간호자 부담을 증가시키는 알츠하이머의 가장 까다로운 증상 중 하나인 초조를 치료하는 데 있어 IGC-AD1의 안전성과 유효성을 평가하는 것을 목표로 합니다.
IGC Pharma (NYSE American:IGC) a étendu son essai de phase 2 pour IGC‑AD1, un candidat‑médicament ciblant l'agitation chez les patients atteints d'Alzheimer, en ajoutant un nouveau site au Lynn Health Science Institute (LHSI) à Oklahoma City.
L'essai CALMA, conçu comme une étude randomisée, en double aveugle et contrôlée par placebo, sera dirigé sur ce site par l'investigateur principal, le Dr Carl Griffin. L'objectif est d'évaluer la sécurité et l'efficacité d'IGC‑AD1 pour traiter l'un des symptômes les plus difficiles de l'Alzheimer — l'agitation — qui conduit souvent à une institutionalisation précoce et augmente le stress des aidants.
IGC Pharma (NYSE American:IGC) hat seine Phase‑2‑Studie zu IGC‑AD1, einem Wirkstoffkandidaten gegen Unruhe bei Alzheimer‑Patienten, um einen neuen Prüfstandort am Lynn Health Science Institute (LHSI) in Oklahoma City erweitert.
Die CALMA‑Studie, konzipiert als randomisierte, doppelblinde, placebokontrollierte Untersuchung, wird an diesem Standort vom Prüfleiter Dr. Carl Griffin geleitet. Ziel ist es, die Sicherheit und Wirksamkeit von IGC‑AD1 bei der Behandlung einer der herausforderndsten Symptome der Alzheimer‑Erkrankung—Unruhe, die häufig zu früher Institutionalisierung und erhöhtem Stress für Pflegepersonen führt—zu bewerten.
- Expansion of clinical trial footprint to a new site in Oklahoma City
- Addition of experienced Principal Investigator Dr. Carl Griffin
- Immediate commencement of patient recruitment at the new site
- None.
POTOMAC, MD / ACCESS Newswire / August 25, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the expansion of its ongoing Phase 2 clinical trial evaluating IGC-AD1, an investigational drug candidate for treating agitation in patients with Alzheimer's disease. The Company has added a clinical site at the Lynn Health Science Institute (LHSI) in Oklahoma City, Oklahoma.
Dr. Carl Griffin, MD, will serve as the Principal Investigator for the site. Dr. Griffin brings extensive experience in conducting clinical trials and a deep commitment to improving outcomes for patients affected by neurodegenerative diseases. He and the team at LHSI will begin recruiting eligible patients immediately.
"Expanding our clinical footprint to Oklahoma represents another important step toward reaching more patients and families affected by this devastating condition," said Ram Mukunda, CEO of IGC Pharma. "We are pleased to welcome Dr. Griffin and the Lynn Health Science Institute to the CALMA trial and look forward to their contributions in advancing our mission."
The CALMA trial is a randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the safety and efficacy of IGC-AD1 in reducing agitation in individuals diagnosed with Alzheimer's disease. Agitation is one of the most challenging and disruptive symptoms associated with Alzheimer's, often leading to earlier institutionalization and significant caregiver stress.
Lynn Health Science Institute is now actively enrolling participants. For more information, please contact:
Mikayla Dade
Clinical Research Coordinator - Lynn Health Science Institute
Email: MDADE@LHSI.NET
Office: (405) 602-3939 ext. 106
To learn more about IGC Pharma and the CALMA trial, please visit www.igcpharma.com.
About Lynn Health Science Institute OKC
Lynn Health Science Institute (LHSI), located in Oklahoma City, Oklahoma, is a premier clinical research facility dedicated to advancing medical science through high-quality clinical trials. With over two decades of experience, LHSI partners with pharmaceutical and biotechnology companies to conduct Phase I-IV trials across a wide range of therapeutic areas. The institute is recognized for its commitment to patient care, data integrity, and research excellence. Under the leadership of seasoned investigators, LHSI strives to contribute to the development of innovative treatments that improve lives and strengthen the future of medicine.
About IGC Pharma (dba IGC):
IGC Pharma (NYSE American: IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With 30 patent filings and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.
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 27, 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. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
Contact Information
Rosalyn Christian / John Nesbett
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
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