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Associated Press
22-05-2025
- Health
- Associated Press
IGC Pharma's Puerto Rico CALMA Trial Site Offers Strategic Opportunity in High-Prevalence Alzheimer's Market
POTOMAC, MD / ACCESS Newswire / May 22, 2025 / IGC Pharma, Inc. ('IGC', or the 'Company') (NYSE American:IGC) today announced a clinical trial site at Santa Cruz Behavioral in Puerto Rico for its CALMA Phase 2 clinical trial, investigating IGC-AD1 for agitation in Alzheimer's disease. This strategic site directly addresses the significant impact of Alzheimer's in the region. Approximately 12.5% of Puerto Ricans over the age of 65 have Alzheimer's, a figure notably higher than the roughly 10% prevalence observed in older non-Hispanic white populations in the U.S. This disparity is influenced by factors such as Puerto Rico's rapidly aging demographic and unique genetic predispositions. The heightened prevalence translates into a substantial economic burden, with medical care for dementia in Puerto Rico accounting for over a quarter of total societal healthcare costs, a proportion higher than in the continental U.S. 'We're pleased to work with Santa Cruz Behavioral ('SCB') as a trial site for our CALMA study, expanding our reach in Puerto Rico alongside a previously announced site at the University of Puerto Rico,' said Ram Mukunda, CEO of IGC Pharma. 'Puerto Rico represents a high-need and underserved population in Alzheimer's care, and SCB strengthens our ability to evaluate IGC-AD1 across diverse patient populations. Diversity in clinical trials not only improves scientific validity but also supports broader regulatory and commercial success.' For IGC Pharma's investors, this initiative represents a strategic imperative. By engaging a vast, underserved market with a high disease prevalence, diverse clinical trials are not only ethically sound but also enhance the commercial viability of therapies by ensuring universal effectiveness. Santa Cruz Behavioral in Puerto Rico, known for its outstanding mental healthcare services from a biopsychosocial perspective, serves as a key partner in this endeavor. Patients and caregivers interested in participating in the CALMA trial should please contact Santa Cruz Behavioral in Bayamon Puerto Rico. 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 76% of Alzheimer's patients, often leading to increased hospitalization and caregiver burden. IGC-AD1 acts as a partial CB1 receptor agonist with anti-neuroinflammatory properties, targeting key pathways involved in neuroinflammation, oxidative stress, and neurotransmitter imbalances. For more information on the CALMA trial, visit: 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 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 [email protected] (203) 972-9200 SOURCE: IGC Pharma, Inc. press release
Associated Press
12-05-2025
- Business
- Associated Press
IGC Pharma Presents Genetic Toxicology Safety Data on API in IGC-AD1, at the 2025 Genetic Toxicology Association Meeting
POTOMAC, MD / ACCESS Newswire / May 12, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ('IGC' or the 'Company') today announced that it presented its latest scientific poster, titled 'Genetic Toxicity Evaluation of Melatonin in the Bacterial Reverse Mutation Assay,' at the 2025 Genetic Toxicology Association Annual Meeting, showcasing key non-clinical data that support the genetic safety profile of one of the two active pharmaceutical ingredients ('API') in IGC-AD1, the Company's investigational drug for Alzheimer's disease. Part of the FDA's battery of safety requirements is to show that APIs are safe for human consumption, including that they do not alter or mutate genes. IGC completed this requirement and is now able to show that the APIs in IGC-AD1 are safe and do not alter genes. 'This is an important milestone, as we prepare the drug for larger trials and eventual commercialization. The geno-tox data was presented at the annual conference on Genetic Toxicology held in Delaware, on May 8, 2025.' Said Ram Mukunda CEO of IGC Pharma. This GLP-compliant study, conducted by an independent lab in Canada, evaluated the API's mutagenic potential using the Bacterial Reverse Mutation Test (commonly known as the Ames test), as part of a broader genetic toxicology battery. The study assessed multiple bacterial strains (Salmonella typhimurium TA1535, TA1537, TA98, TA100 and Escherichia coli WP2 trp uvrA) both in the presence (+S9) and absence (-S9) of an exogenous mammalian metabolic activation system, as per OECD Guideline 471 and ICH S2(R1) recommendations. At various concentrations ranging from 1.6 to 5000 µg/plate, no evidence of mutagenicity was observed at any dose level. Across all strains and experimental conditions, Fold Response values remained below 2-the established threshold for mutagenic activity. Revertant colony counts remained within the range of the negative controls and substantially lower than the positive controls, confirming assay validity. Additionally, statistical analysis using Dunnett's test showed no significant dose-related increases (p > 0.05), reinforcing the conclusion that the API does not induce gene mutations under the tested conditions. To access the full poster or learn more about IGC Pharma's ongoing research, please visit the LINK. 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 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 [email protected] (203) 972-9200 SOURCE: IGC Pharma, Inc. press release
Associated Press
24-04-2025
- Business
- Associated Press
IGC Pharma Welcomes Strategic Investment from Advisors
POTOMAC, MARYLAND / ACCESS Newswire / April 24, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ('IGC' or the 'Company') today announced that the Company's recently appointed advisors entered into a Share Purchase Agreement (the 'SPA') on April 21, 2025, for the purchase of common shares from the Company. The investment, subject to the terms and conditions set forth in the SPA, is for approximately $475 thousand at the higher of 30 cents or $0.01 over the last closing price. The completion of the private placement is subject to customary closing conditions, including approval by the NYSE. Under the terms of the SPA, IGC will issue 1,583,333 shares of common stock. The shares are unregistered, subject to 144 restrictions, and are not tradable for a six-month period. The funds will support general corporate purposes and the Company's advancement of CALMA Phase 2 clinical trial on agitation in Alzheimer's disease. Ram Mukunda, CEO commented, 'We're pleased to see this strong vote of confidence from our new advisors. Their strategic investment underscores their belief in IGC Pharma's mission to transform the Alzheimer's treatment landscape. We look forward to working with our Advisors in accelerating our Phase 2 CALMA trial and building long-term value for shareholders.' Please note that this press release does not constitute an offer to sell or a solicitation of an offer to buy these securities. Furthermore, there shall be no sale of the securities in any state in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of the respective state. About IGC Pharma's New Advisors: Frank Zaccanelli, a seasoned entrepreneur and former President, General Manager, and minority owner of the Dallas Mavericks, under Perot family's majority ownership. He led the development of the American Airlines Center in Dallas Texas and has been a public commentator on finance, politics, global strategy, and brings decades of leadership in venture capital, private equity, and public-private partnerships. Mr. Zaccanelli will support IGC Pharma in identifying and cultivating strategic partnerships, as well as advising on the Company's engagement with brand ambassador and key influencers in the Alzheimer's space. Robert K. Coughlin, former President and CEO of MassBio, has been a champion of biotech innovation and recently received the 2025 Henri A. Termeer Innovative Leadership Award for his enduring contributions to the life sciences ecosystem. As a cystic fibrosis parent, Bob works tirelessly to raise awareness and invest in companies working on cystic fibrosis. His public service includes time as a Massachusetts State Representative and Undersecretary of Economic Development. Mr. Coughlin will support IGC's Alzheimer's regulatory strategy, clinical engagement, and support relations with pharmaceutical companies. Joseph H. Mangan is a retired brand strategist, a current Knight of the Order of Malta, and a board member of the New York Athletic Club. Joe has been committed to humanitarian aid and service to those in need. His deep empathy for vulnerable populations, particularly the elderly, aligns closely with IGC Pharma's mission to support Alzheimer's patients and caregivers. Mr. Mangan will advise the Company on strategic partnerships with clinical sites, hospitals, and Alzheimer's foundations. 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 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 [email protected] (203) 972-9200 SOURCE: IGC Pharma, Inc. press release
Associated Press
20-03-2025
- Business
- Associated Press
IGC Pharma Announces CALMA Phase 2 Trial Expansion with the Addition of Canadian Hamilton Health Sciences
POTOMAC, MD / / 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 76% of Alzheimer's patients, often leading to increased hospitalization and caregiver burden. IGC-AD1 acts as a partial CB1 receptor agonist with anti-neuroinflammatory properties, targeting key pathways involved in neuroinflammation, oxidative stress, and neurotransmitter imbalances. 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: 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 ( 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. (203) 972-9200 SOURCE: IGC Pharma, Inc.
Globe and Mail
04-03-2025
- Business
- Globe and Mail
IGC Pharma Expands AI Platform With Advanced Diagnostic Model for Alzheimer's and Dementia Detection
POTOMAC, MD / ACCESS Newswire / March 4, 2025 / IGC Pharma, Inc. ("IGC" or the "Company") (NYSE American:IGC) today announced an advancement in its Artificial Intelligence ("AI") platform with the development of a new AI-driven model designed to improve the diagnosis of Alzheimer's disease (AD) and other causes of dementia. With Alzheimer's accounting for approximately 60-80% of all dementia cases, alongside other conditions such as vascular disease, Lewy body disease, and frontotemporal degeneration, accurate diagnosis is critical to ensuring the right treatment strategy. Dementia affects over 55 million people worldwide, causing progressive cognitive decline, memory loss, and behavioral changes. Despite its widespread impact, current diagnostic methods often rely on invasive procedures, expensive imaging, and subjective clinical assessments, leading to high rates of misdiagnosis and delayed treatment. IGC Pharma's cutting-edge AI model is designed to address these challenges by integrating vast clinical datasets and leveraging deep learning algorithms to distinguish between the different diseases that cause dementia. By reducing false negatives and misdiagnoses, the model has the potential to significantly improve early detection, ensuring patients receive the right treatment at the right time. The AI model is being trained on multi-modal clinical data from leading public research databases, including the National Alzheimer's Coordinating Center (NACC), the Alzheimer's Disease Neuroimaging Initiative (ADNI), and the Parkinson's Progression Markers Initiative (PPMI), among others. By analyzing neuroimaging biomarkers, cognitive assessments, genetic risk factors, medical history, neurological exams, and demographic information, IGC Pharma's AI-driven approach enables a more precise and scalable diagnostic framework. Using state-of-the-art transformer-based neural networks, the model's architecture is designed to process diverse patient data while compensating for missing information-delivering reliable, personalized insights across different patient populations. "The AI model is a potential game changer for our growth strategy. Our AI platform is a key driver of IGC Pharma's long-term growth strategy, reinforcing our commitment to precision medicine and targeted treatments for neurodegenerative diseases," said Ram Mukunda, CEO of IGC Pharma. "Misdiagnosis remains a significant challenge, often delaying treatment for patients who need it most. Our AI-driven model aims to close this gap, ultimately improving patient outcomes." This initiative is part of IGC Pharma's broader AI strategy, positioning the company at the forefront of innovation in Alzheimer's research. The development of an AI foundation model for Alzheimer's disease and dementia detection represents a transformative step forward, not only in advancing medical breakthroughs but also in enhancing the Company's long-term value and leadership in AI-driven healthcare solutions. 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 ( 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-Q filed with the SEC on August 7, 2024, 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. SOURCE: IGC Pharma, Inc. View the original press release on ACCESS Newswire
