IGC Pharma Adds Ichor Research as New Site for CALMA Phase 2 Alzheimer's Trial
IGC Pharma (NYSE American: IGC) announced the addition of Ichor Research in Syracuse, New York, as a new clinical trial site for its ongoing Phase 2 CALMA trial. The study evaluates IGC-AD1, an investigational drug candidate for treating agitation in Alzheimer's disease patients.
The trial, designed as a randomized, double-blind, placebo-controlled study, will be led by Principal Investigator Dr. Karl F. Hafner, M.D. at the new site. The CALMA trial aims to assess the safety and efficacy of IGC-AD1 in reducing agitation symptoms, which are among the most common and distressing behavioral symptoms in Alzheimer's patients.
IGC Pharma (NYSE American: IGC) ha annunciato l'inserimento di Ichor Research a Syracuse, New York, come nuova sede di sperimentazione clinica per il suo attuale studio di fase 2 CALMA. Lo studio valuta IGC-AD1, candidato farmaco sperimentale per trattare l’agitazione nei pazienti con malattia di Alzheimer.
Lo studio, progettato come randomizzato, in doppio cieco e controllato con placebo, sarà guidato dal Principal Investigator Dr. Karl F. Hafner, M.D., presso il nuovo sito. L’obiettivo dello studio CALMA è valutare la sicurezza e l’efficacia di IGC-AD1 nel ridurre i sintomi di agitazione, tra i più comuni e debilitanti comportamenti osservati nei pazienti affetti da Alzheimer.
IGC Pharma (NYSE American: IGC) anunció la incorporación de Ichor Research en Syracuse, Nueva York, como nuevo sitio de ensayo clínico para su actual ensayo de fase 2 CALMA. El estudio evalúa IGC-AD1, candidato experimental para tratar la agitación en pacientes con Alzheimer.
El ensayo, diseñado como un estudio aleatorizado, doble ciego y controlado con placebo, será dirigido por el Investigador Principal Dr. Karl F. Hafner, M.D., en el nuevo sitio. El objetivo del ensayo CALMA es evaluar la seguridad y la eficacia de IGC-AD1 para reducir los síntomas de agitación, entre los comportamientos más comunes y angustiantes en pacientes con Alzheimer.
IGC Pharma (NYSE American: IGC)가 뉴욕 주 시라큐스의 Ichor Research를 새로운 임상 시험 사이트로 추가했습니다. 이는 현재 진행 중인 2상 CALMA 연구의 신규 사이트입니다. 이 연구는 알츠하이머 질환 환자에서의 안절부절함을 치료하기 위한 후보 약물 IGC-AD1을 평가합니다.
이 연구는 무작위, 이중 맹검, 위약 대조 연구로 설계되었으며, 새 사이트의 주 연구책임의 Dr. Karl F. Hafner 박사가 주도합니다. CALMA 연구의 목적은 알츠하이머 환자에서 가장 흔하고 고통스러운 행동 증상 중 하나인 안절부절함의 안전성과 유효성을 IGC-AD1이 얼마나 개선하는지 평가하는 것입니다.
IGC Pharma (NYSE American: IGC) a annoncé l’ajout de Ichor Research à Syracuse, dans l’État de New York, comme nouveau site d’essai clinique pour son actuel essai de phase 2 CALMA. L’étude évalue IGC-AD1, candidat médicament expérimental destiné à traiter l’agitation chez les patients atteints de la maladie d’Alzheimer.
L’essai, conçu comme une étude randomisée, en double aveugle et contrôlée par placebo, sera dirigé par le Investigateur principal Dr. Karl F. Hafner, M.D., sur le nouveau site. L’objectif de l’essai CALMA est d’évaluer la sécurité et l’efficacité de IGC-AD1 pour réduire les symptômes d’agitation, parmi les comportements les plus fréquents et les plus débilitants chez les patients Alzheimer.
IGC Pharma (NYSE American: IGC) gab die Aufnahme von Ichor Research in Syracuse, New York, als neue klinische Studienstelle für die laufende Phase-2-CALMA-Studie bekannt. Die Untersuchung bewertet IGC-AD1, einen experimentellen Arzneimittelkandidaten zur Behandlung von Unruhe bei Patienten mit Alzheimer-Krankheit.
Die Studie ist als randomisierte, doppelt verblindete und placebokontrollierte Untersuchung konzipiert und wird am neuen Standort von Principal Investigator Dr. Karl F. Hafner, M.D., geleitet. Ziel der CALMA-Studie ist es, die Sicherheit und Wirksamkeit von IGC-AD1 bei der Reduktion von Unruhe-Symptomen zu bewerten, zu denen zu den häufigsten und belastendsten Verhaltenssymptomen bei Alzheimer-Patienten gehören.
IGC Pharma (NYSE American: IGC) أعلنت عن إضافة Ichor Research في سارايزوغا، نيويورك، كموقع تجربة سريرية جديدة لدرْاستها المستمرة من المرحلة 2 CALMA. تقيِّم الدراسة IGC-AD1، وهو مرشح دواء تجريبي لعلاج الهياج لدى مرضى الزهايمر.
وستُجرى التجربة، المصممة كـ دراسة عشوائية مزدوجة التعمية ومضبوطة بسيبو، بقيادة الباحث الرئيسي الدكتور كارل ف. هافنر، MD، في الموقع الجديد. تهدف CALMA إلى تقييم سلامة وفعالية IGC-AD1 في تقليل أعراض الهياج، وهي من أكثر السلوكيات شيوعًا والمعاناة لدى مرضى الزهايمر.
IGC Pharma (NYSE American: IGC) 已宣布在纽约州雪城新增 Ichor Research 作为其正在进行的 阶段2 CALMA 试验的新临床试验点。该研究评估 IGC-AD1，一种用于治疗阿尔茨海默病患者易激动的药物候选。
该试验为 随机、双盲、安慰剂对照的研究，将在新地点由首席研究员 Dr. Karl F. Hafner, M.D. 主导。CALMA 试验旨在评估 IGC-AD1 在减少易激动症状方面的安全性和有效性，这些症状是阿尔茨海默病患者中最常见且最令人痛苦的行为表现之一。
- Addition of new clinical trial site expands patient access and recruitment potential
- Immediate enrollment initiation at the new site indicates operational readiness
- Experienced Principal Investigator with expertise in neurodegenerative conditions
- None.
POTOMAC, MD / ACCESS Newswire / September 29, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the addition of a new clinical trial site to its ongoing Phase 2 study evaluating IGC-AD1, an investigational drug candidate for treating agitation in Alzheimer's disease. The new site, Ichor Research, located in Syracuse, New York, is led by Principal Investigator Dr. Karl F. Hafner, M.D.
Dr. Hafner brings years of experience in clinical research and patient care, particularly in the field of neurodegenerative conditions. Ichor Research began enrolling eligible participants for the CALMA trial immediately.
The CALMA Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of IGC-AD1 in reducing agitation symptoms in individuals living with Alzheimer's disease. Agitation is one of the most prevalent and distressing behavioral symptoms in Alzheimer's patients, often accelerating disease progression and increasing caregiver burden.
"We are proud to partner with Ichor Research as part of our commitment to expand access to innovative treatment options for patients and caregivers," said Ram Mukunda, CEO of IGC Pharma. "Dr. Hafner, and the team at Ichor bring valuable expertise that will help advance the CALMA trial."
Contact Information:
Kristen Stebbins
VP of Clinical Trial Operations
1101 Erie Blvd East, Suite 201
Syracuse, NY 13210
Office: 315-904-5004
Email: kstebbins@ichorlifesciences.com
To learn more about IGC Pharma and the CALMA trial, please visit: Link
About Ichor Research
Research Central LLC, operating as Ichor Research, is a clinical research organization based in Syracuse, New York, with expertise in clinical trials for Alzheimer's disease. Ichor Research is dedicated to overcoming the unique challenges involved in Alzheimer's disease clinical trials, advancing medical innovation through high-quality, patient-focused clinical trials. Under the leadership of experienced clinical trials experts Lisa Sonneborn and Kristen Stebbins, Ichor collaborates with industry sponsors to evaluate novel treatments across a variety of therapeutic areas. The site is committed to ethical research practices, scientific integrity, and improving outcomes for patients through the development of evidence-based medical therapies.
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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