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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
21-04-2025
- Business
- Associated Press
IGC Pharma Welcomes Industry Leaders to Advisory Board, Supporting Alzheimer's Innovation and AI-Driven Programs
Industry Veterans Bring Deep Strategic Experience to Guide Alzheimer's Clinical Expansion and Commercial Strategy POTOMAC, MARYLAND / ACCESS Newswire / April 21, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ('IGC Pharma' or the 'Company') today announced the addition of Frank Zaccanelli, Robert K. Coughlin, and Joseph Mangan to its Board of Advisors. The Advisory Board will provide strategic guidance as IGC advances its Alzheimer's drug development and AI driven early dementia detection programs. 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. 'We warmly welcome our new members to the Advisory Board and look forward to working together as we advance our Alzheimer's clinical strategy and AI driven early dementia detection programs,' said Ram Mukunda, CEO of IGC Pharma. 'Their diverse expertise across biotechnology, brand strategy, and business development adds meaningful depth to our leadership as we advance our Alzheimer's clinical and AI programs. With their guidance, we are better positioned to scale responsibly, accelerate our mission, and deliver sustained value to both patients and shareholders.' 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
08-04-2025
- Health
- Associated Press
IGC Pharma Expands CALMA Alzheimer's Phase 2 Trial with Prestigious Research Site at Butler Hospital's Memory and Aging Program
POTOMAC, MARYLAND / ACCESS Newswire / April 8, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ('IGC Pharma' or the 'Company') today announced the expansion of its ongoing Phase 2 CALMA clinical trial with the addition of Butler Hospital's Memory and Aging Program, a nationally recognized research center affiliated with the Warren Alpert Medical School of Brown University, in Providence, Rhode Island. The site will support enrollment for the CALMA study evaluating IGC-AD1, IGC Pharma's investigational therapy for agitation in Alzheimer's disease, a condition affecting a majority of Alzheimer's patients and significantly impacting caregivers. Dr. Meghan Riddle, Associate Director of Butler Hospital's Memory and Aging Program and Associate Professor at The Warren Alpert Medical School of Brown University, will lead the trial at Butler. A geriatric psychiatrist, Dr. Riddle specializes in late-life mood disorders and neuropsychiatric symptoms related to dementia, bringing deep clinical and research expertise to the CALMA trial. Butler Hospital's Memory and Aging Program ('MAP') is a nationally recognized leader in Alzheimer's research, dedicated to the prevention, diagnosis, and treatment of neurodegenerative diseases. The program provides comprehensive care for individuals and families affected by Alzheimer's, dementia, and memory loss, while advancing the field through cutting-edge clinical research and innovation in treatment strategies. 'We are excited to collaborate with Butler Hospital's Memory and Aging Program in advancing the CALMA clinical trial,' said Ram Mukunda, CEO of IGC Pharma. 'Their commitment to innovative patient care and cutting-edge research makes them a valuable partner in our mission to address the challenges of agitation in Alzheimer's patients. This expansion marks another important step in progressing our trial, bringing us closer to potential commercializing effective solutions for patients in need.' IGC Pharma's CALMA Phase 2 trial is being conducted in the United States, and Canada, with a goal of enrolling 146 participants. The study aims to evaluate IGC-AD1's potential in reducing agitation in Alzheimer's dementia, one of the most difficult-to-manage aspects of Alzheimer's disease. 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 55 patent filings and a commitment to innovation, IGC Pharma is advancing breakthrough therapies. Additionally, the Company operates Holiby™, a wellness brand offering scientifically formulated products for immunity, energy, and longevity. About the Memory and Aging Program at Butler Hospital: The Memory & Aging Program (MAP) at Butler Hospital is a worldwide leader in Alzheimer's disease research and a local Rhode Island partner in the fight against Alzheimer's and other forms of dementia. An affiliate of The Warren Alpert Medical School of Brown University, MAP has a 25-year history of excellence in Alzheimer's clinical care, training, and research aimed at developing new and better ways to detect, treat, and someday even prevent Alzheimer's. Individuals who wish to be considered for participation in current and future research studies and clinical trials conducted at the Memory and Aging Program for the prevention and treatment of Alzheimer's disease can join the program's Alzheimer's Prevention Registry at Butler Hospital online at or by calling (401) 455-6402. For more information visit and follow on Facebook and Twitter. About Butler Hospital: Butler Hospital, a member of Care New England, is the only private, nonprofit psychiatric and substance abuse hospital serving adults, seniors and adolescents in Rhode Island and southeastern New England. Founded in 1844, it was the first hospital in Rhode Island and has earned a reputation as the leading provider of innovative psychiatric treatments in the region. The Major Affiliated Teaching Hospital for Psychiatry and Behavioral Health at The Warren Alpert Medical School of Brown University, Butler is recognized worldwide as a pioneer in conducting cutting-edge research. For more information, visit 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
