Latest news with #GoodLaboratoryPractice
Yahoo
14-05-2025
- Business
- Yahoo
Silo Pharma Selects Veloxity Labs for Bioanalytical IND-Enabling Study for our Novel Intranasal PTSD Therapy, SPC-15
SARASOTA, FL, May 14, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) ('Silo' or the 'Company'), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has engaged Veloxity Labs, LLC for bioanalysis supporting the ongoing investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). 'We look forward to working with Veloxity Labs for GLP sample analysis in our current safety study of SPC-15,' said Eric Weisblum, CEO of Silo. 'We expect Veloxity to provide fast turnaround times and precise, high-quality data, and we believe their team will play an important role in delivering preclinical data we need to open an IND for SPC-15.' Silo expects to begin the FDA IND process for SPC-15 in 2025. Upon approval of the IND, Silo will proceed to a first-in-human Phase 1 clinical trial. About Silo PharmaSilo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company's portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer's disease and multiple sclerosis. Silo's research is conducted in collaboration with leading universities and laboratories. Forward-Looking StatementsThis news release contains "forward-looking statements" within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words 'could', 'believe', 'anticipate', 'intend', 'estimate', 'expect', 'may', 'continue', 'predict', 'potential', and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. ('Silo' or 'the Company') to differ materially from the results expressed or implied by such statements, including the Company's ability to successfully complete its preclinical studies and generate positive data, the risk that the FDA may not accept or may require changes to the IND, or may not allow the Company to proceed with clinical trials, the risk that the FDA may not approve SPC-15 on the Company's expected timeline, or at all, changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company's technology platforms, retaining and expanding the Company's customer base, fluctuations in consumer spending on the Company's products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law. Contact800-705-0120investors@ in to access your portfolio
Business Upturn
14-05-2025
- Business
- Business Upturn
Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories
SARASOTA, FL, May 14, 2025 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (Nasdaq: SILO) ('Silo' or the 'Company'), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has entered into an agreement with Frontage Laboratories, a global full-service CRO (contract research organization), for a Food and Drug Administration (FDA) requested 7-day safety and toxicology large animal study of its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). 'We are conducting a 7-day safety and toxicology study to gather additional data that is expected to supplement and reinforce our SPC-15 investigational new drug (IND) application to the FDA,' said Eric Weisblum, CEO of Silo. 'We currently remain on track to begin an FDA submission this year.' The Company is currently working on a separate IND-enabling Good Laboratory Practice (GLP) -compliant toxicology and toxicokinetic study of SPC-15. Positive preclinical data from these studies, if achieved, would support an IND submission for SPC-15 in 2025. Should Silo receive approval of the IND, Silo would proceed to a first-in-human Phase 1 clinical trial for SPC-15. Columbia University, the Company's collaboration partner for pre-clinical development, granted Silo an exclusive global license to further develop, manufacture, and commercialize SPC-15 worldwide. About SPC-15 SPC-15 is an intranasal serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders such as PTSD and anxiety. With its potential eligibility for the FDA's streamlined 505(b)(2) regulatory pathway, SPC-15 offers a promising approach to accelerate the approval process. Silo Pharma is collaborating with Columbia University to conduct preclinical studies and has exclusive global rights to the development and commercialization of SPC-15. About Frontage Frontage Laboratories is a US-based Contract Research Organization (CRO) that was initially established in New Jersey in April 2001 and later relocated to Pennsylvania in 2004. As an FDA-registered and inspected global pharmaceutical development and manufacturing organization, we are headquartered in Exton, PA, with an impressive network of 25 facilities spread across Pennsylvania, New Jersey, Illinois, Ohio, California, Florida, Canada, Italy, and China. We are dedicated to accelerating the development of innovative therapies by providing a broad range of science driven and quality focused services for drug discovery, DMPK, preclinical, formulation development and CTM, Analytical, clinical trials, bioanalytical and commercial-scale manufacturing. About Silo Pharma Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company's portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer's disease and multiple sclerosis. Silo's research is conducted in collaboration with leading universities and laboratories. Forward-Looking StatementsThis news release contains 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words 'could', 'believe', 'anticipate', 'intend', 'estimate', 'expect', 'may', 'continue', 'predict', 'potential', and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. ('Silo' or 'the Company') to differ materially from the results expressed or implied by such statements, including the Company's ability to successfully complete its preclinical studies and generate positive data, the risk that the FDA may not accept or may require changes to the IND, or may not allow the Company to proceed with clinical trials, the risk that the FDA may not approve SPC-15 on the Company's expected timeline, or at all, changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company's technology platforms, retaining and expanding the Company's customer base, fluctuations in consumer spending on the Company's products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law.
Associated Press
14-05-2025
- Business
- Associated Press
Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories
SARASOTA, FL, May 14, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) ('Silo' or the 'Company'), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has entered into an agreement with Frontage Laboratories, a global full-service CRO (contract research organization), for a Food and Drug Administration (FDA) requested 7-day safety and toxicology large animal study of its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). 'We are conducting a 7-day safety and toxicology study to gather additional data that is expected to supplement and reinforce our SPC-15 investigational new drug (IND) application to the FDA,' said Eric Weisblum, CEO of Silo. 'We currently remain on track to begin an FDA submission this year.' The Company is currently working on a separate IND-enabling Good Laboratory Practice (GLP) -compliant toxicology and toxicokinetic study of SPC-15. Positive preclinical data from these studies, if achieved, would support an IND submission for SPC-15 in 2025. Should Silo receive approval of the IND, Silo would proceed to a first-in-human Phase 1 clinical trial for SPC-15. Columbia University, the Company's collaboration partner for pre-clinical development, granted Silo an exclusive global license to further develop, manufacture, and commercialize SPC-15 worldwide. About SPC-15 SPC-15 is an intranasal serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders such as PTSD and anxiety. With its potential eligibility for the FDA's streamlined 505(b)(2) regulatory pathway, SPC-15 offers a promising approach to accelerate the approval process. Silo Pharma is collaborating with Columbia University to conduct preclinical studies and has exclusive global rights to the development and commercialization of SPC-15. About Frontage Frontage Laboratories is a US-based Contract Research Organization (CRO) that was initially established in New Jersey in April 2001 and later relocated to Pennsylvania in 2004. As an FDA-registered and inspected global pharmaceutical development and manufacturing organization, we are headquartered in Exton, PA, with an impressive network of 25 facilities spread across Pennsylvania, New Jersey, Illinois, Ohio, California, Florida, Canada, Italy, and China. We are dedicated to accelerating the development of innovative therapies by providing a broad range of science driven and quality focused services for drug discovery, DMPK, preclinical, formulation development and CTM, Analytical, clinical trials, bioanalytical and commercial-scale manufacturing. About Silo Pharma Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company's portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer's disease and multiple sclerosis. Silo's research is conducted in collaboration with leading universities and laboratories. Forward-Looking Statements This news release contains 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words 'could', 'believe', 'anticipate', 'intend', 'estimate', 'expect', 'may', 'continue', 'predict', 'potential', and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. ('Silo' or 'the Company') to differ materially from the results expressed or implied by such statements, including the Company's ability to successfully complete its preclinical studies and generate positive data, the risk that the FDA may not accept or may require changes to the IND, or may not allow the Company to proceed with clinical trials, the risk that the FDA may not approve SPC-15 on the Company's expected timeline, or at all, changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company's technology platforms, retaining and expanding the Company's customer base, fluctuations in consumer spending on the Company's products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law. Contact 800-705-0120 [email protected]
Yahoo
26-03-2025
- Business
- Yahoo
Silo Pharma Achieves Key Milestone with First Dosing in IND-Enabling GLP Study for SPC-15 as a Groundbreaking PTSD Treatment
SARASOTA, FL, March 26, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) ('Silo' or the 'Company'), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced first dosing in an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). 'This IND-enabling safety study and our concurrent GLP-compliant pharmacokinetic and pharmacodynamic study, if successful, will provide the last preclinical data needed to open an IND for SPC-15,' said Eric Weisblum, CEO of Silo. 'We are following the FDA's helpful responses to our pre-IND submission, which provide a clear path to an IND submission to first-in-human clinical studies.' Silo Pharma completed a pre-IND meeting in September 2024 to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 and review the Company's proposed plan to support opening an IND. The FDA's 505(b)(2) drug development route can significantly shorten clinical timelines for FDA approval and reduce drug development costs. About SPC-15SPC-15 is an intranasal serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders such as PTSD and anxiety. With its potential eligibility for the FDA's streamlined 505(b)(2) regulatory pathway, SPC-15 offers a promising approach to accelerate the approval process. Silo Pharma is collaborating with Columbia University to conduct preclinical studies and has exclusive global rights to the development and commercialization of SPC-15. About Silo PharmaSilo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company's portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer's disease and multiple sclerosis. Silo's research is conducted in collaboration with leading universities and laboratories. Forward-Looking StatementsThis news release contains "forward-looking statements" within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words 'could', 'believe', 'anticipate', 'intend', 'estimate', 'expect', 'may', 'continue', 'predict', 'potential', and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. ('Silo' or 'the Company') to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company's technology platforms, retaining and expanding the Company's customer base, fluctuations in consumer spending on the Company's products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law. Contact800-705-0120investors@ in to access your portfolio
