An Open-label Trial of an Erythropoietin Stimulating System to Determine Increased Red Blood Cell Production in Subjects Diagnosed With Anemia of Chronic Disease

The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system.

开始日期2013-06-01

申办/合作机构

Targeted Medical Pharma, Inc.

NCT01701531 / Withdrawn临床2/3期

An Open-Label, Pilot Study of a Red Blood Cell Precursor Formulation to Determine Increased Production in Subjects With Mild to Moderate Anemia

The objective of this study is to measure the change in hemoglobin levels after the administration of an amino acid based, RBC precursor formulation.

开始日期2012-10-01

申办/合作机构

Targeted Medical Pharma, Inc.

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项与 Targeted Medical Pharma, Inc. 相关的文献（医药）

2016-11-01·American Journal of Therapeutics4区 · 医学

Reduction in Pain and Inflammation Associated With Chronic Low Back Pain With the Use of the Medical Food Theramine

4区 · 医学

Article

作者: Silver, David ; Shell, William E ; Silver, Michael ; Pavlik, Stephanie ; Roth, Brandon ; May, Lawrence ; Breitstein, Mira L

Management of chronic back pain is a challenge for physicians. Although standard treatments exert a modest effect, they are associated with narcotic addiction and serious side effects from nonsteroidal antiinflammatory agents. Moreover, neurotransmitter depletion from both the pain syndrome and therapy may contribute to a poor treatment outcome. Neurotransmitter deficiency may be related both to increased turnover rate and inadequate neurotransmitter precursors from the diet, particularly for essential and semi-essential amino acids. Theramine, an amino acid blend 68405-1 (AAB), is a physician-prescribed only medical food. It contains neurotransmitter precursors and systems for increasing production and preventing attenuation of neurotransmitters. A double-blind controlled study of AAB, low-dose ibuprofen, and the coadministration of the 2 agents were performed. The primary end points included the Roland Morris index and Oswestry disability scale. The cohort included 122 patients aged between 18 and 75 years. The patients were randomized to 1 of 3 groups: AAB alone, ibuprofen alone, and the coadministration of the 2 agents. In addition, C-reactive protein, interleukin 6, and plasma amino acid concentrations were measured at baseline and 28 days time points. After treatment, the Oswestry Disability Index worsened by 4.52% in the ibuprofen group, improved 41.91% in the AAB group, and improved 62.15% in the combination group. The Roland Morris Index worsened by 0.73% in the ibuprofen group, improved by 50.3% in the AAB group, and improved 63.1% in the combination group. C-reactive protein in the ibuprofen group increased by 60.1%, decreased by 47.1% in the AAB group, and decreased by 36% in the combination group. Similar changes were seen in interleukin 6. Arginine, serine, histidine, and tryptophan levels were substantially reduced before treatment in the chronic pain syndrome and increased toward normal during treatment. There was a direct correlation between improvement in amino acid concentration and treatment response. Treatment with amino acid precursors was associated with substantial improvement in chronic back pain, reduction in inflammation, and improvement in back pain correlated with increased amino acid precursors to neurotransmitters in blood.

2015-02-01·Neuropsychopharmacology1区 · 医学

Evidence that Formulations of the Selective MAO-B Inhibitor, Selegiline, which Bypass First-Pass Metabolism, also Inhibit MAO-A in the Human Brain

1区 · 医学

Article

作者: Shea, Colleen ; Carter, Pauline ; Muench, Lisa ; Jayne, Millard ; Gilmor, Michelle ; Shumay, Elena ; Wang, Gene-Jack ; Telang, Frank ; Fahn, Stanley ; Alexoff, David L ; King, Payton ; McCall-Perez, Fred ; Apelskog-Torres, Karen ; Logan, Jean ; Xu, Youwen ; Volkow, Nora D ; Hubbard, Barbara ; Fowler, Joanna S

Selegiline (L-deprenyl) is a selective, irreversible inhibitor of monoamine oxidase B (MAO-B) at the conventional dose (10 mg/day oral) that is used in the treatment of Parkinson's disease. However, controlled studies have demonstrated antidepressant activity for high doses of oral selegiline and for transdermal selegiline suggesting that when plasma levels of selegiline are elevated, brain MAO-A might also be inhibited. Zydis selegiline (Zelapar) is an orally disintegrating formulation of selegiline, which is absorbed through the buccal mucosa producing higher plasma levels of selegiline and reduced amphetamine metabolites compared with equal doses of conventional selegiline. Although there is indirect evidence that Zydis selegiline at high doses loses its selectivity for MAO-B, there is no direct evidence that it also inhibits brain MAO-A in humans. We measured brain MAO-A in 18 healthy men after a 28-day treatment with Zydis selegiline (2.5, 5.0, or 10 mg/day) and in 3 subjects receiving the selegiline transdermal system (Emsam patch, 6 mg/day) using positron emission tomography and the MAO-A radiotracer [(11)C]clorgyline. We also measured dopamine transporter (DAT) availability in three subjects from the 10 mg group. The 10 mg Zydis selegiline dose significantly inhibited MAO-A (36.9±19.7%, range 11-70%, p<0.007)) but not DAT; and while Emsam also inhibited MAO-A (33.2±28.9 (range 9-68%) the difference did not reach significance (p=0.10)) presumably because of the small sample size. Our results provide the first direct evidence of brain MAO-A inhibition in humans by formulations of selegiline, which are currently postulated but not verified to target brain MAO-A in addition to MAO-B.

2014-01-01·Journal of Central Nervous System Disease

Administration of an Amino Acid–Based Regimen for the Management of Autonomic Nervous System Dysfunction Related to Combat-Induced Illness

Article

作者: May, Lawrence ; Shell, William E ; Breitstein, Mira ; Silver, David S. ; Charuvastra, Marcus ; Charuvastra, Anthony ; Pavlik, Stephanie L.

The etiology and pathophysiology of posttraumatic stress disorder (PTSD) remains poorly understood. The nutritional deficiencies associated with the altered metabolic processes of PTSD have not previously been studied in detail. This pilot study measured the reduction in symptoms in 21 military veterans reporting moderate to severe symptoms associated with PTSD. Two amino acid-based medical foods specifically formulated with biogenic amines and other nutrients were administered to study subjects targeting specific neurotransmitter deficiencies resulting from altered metabolic activity associated with PTSD. This study included the Physician Checklist – Military (PCL-M), Short Form General Health Survey (SF-36), and Epworth Sleepiness Scale to measure the change in each subject's score after 30 days of administration. An average decrease of 17 points was seen in the PCL-M, indicating a reduction in PTSD symptoms ( P < 0.001). The mental health component of the SF-36 showed an average 57% increase in the subjects’ mental health rating ( P < 0.001). The results of this initial study demonstrate that addressing the increased dietary requirements of PTSD can improve symptoms of the disease while eliminating significant side effects. A larger, double-blind, randomized, placebo-controlled trial is warranted.

项与 Targeted Medical Pharma, Inc. 相关的新闻（医药）

2022-07-22

·GlobeNewswire-Health Care

ITM Appoints Dr. Sebastian Marx as Chief Business Officer and Member of Executive Board

Garching / Munich, July 22, 2022 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the appointment of Dr. Sebastian Marx to its Executive Board as Chief Business Officer (CBO) of the ITM Group. Dr. Marx joined ITM in 2008 and has since contributed significantly to the company’s growth and development across various product management positions, including Head of Sales. As CBO, Dr. Marx will strengthen the company’s marketing focus as it prepares for the potential product launch of its radiopharmaceutical lead candidate, ITM-11, for the treatment of neuroendocrine tumors (GEP-NETs). In his new role, he will have overall responsibility for marketing and sales, and market access and intelligence for the company’s radioisotopes, radiodiagnostics and radiotherapeutics as well as the further expansion of its global sales partner network. “ITM’s extraordinary growth trajectory over the past years has positioned us as a leader in the production and global distribution of high-quality medical radioisotopes while developing a broad precision oncology pipeline,” said Steffen Schuster, CEO of ITM. “We appreciate Sebastian’s accomplishments over the past 14 years at ITM and warmly welcome him to the Board. His broad experience across the radiopharmaceutical and sales sectors are an invaluable asset to ITM as we pursue our goal of providing physicians and patients worldwide with improved therapies for hard-to-treat cancers.” Commenting on his appointment, Dr. Sebastian Marx, CBO of ITM, added, “ITM has the advantage of being able to bring its products to global partners independently while applying its expertise in the development of high-quality radioisotopes directly to its pipeline. Over the course of my career here, I have experienced first-hand how the company has built an extraordinary team passionate about delivering improved therapeutic solutions to patients and clinicians. I look forward to bringing my previous sales and product development experiences at ITM to my new position and to ensuring that our distribution capabilities support our radiopharmaceutical candidates as they approach potential market launch.” Dr. Marx has held various positions in research and development, production, quality, product management and partner management at ITM and was appointed Head of Sales in 2014. Together with his team, he helped build the company’s international customer base and distribution partner network, which greatly contributed to ITM securing its role as a world market leader in the radiopharmaceutical field. In addition to his industry contacts, deep knowledge of the production and development of radioisotopes, Dr. Marx is well versed in the fundamentals of analytics, radiochemistry, and nuclear medicine. He holds a PhD in chemistry from the Technical University of Munich (TUM), Germany. The Executive Board of ITM now consists of Steffen Schuster, CEO, Dr. Klaus Maleck, CFO, and Dr. Sebastian Marx, CBO. About Targeted Radionuclide TherapyTargeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, like receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization enables targeted treatment with minimal impact to healthy surrounding tissue. ITM Isotope Technologies Munich SEITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com ITM ContactCorporate CommunicationsJulia Hofmann / Susanne KarlssonPhone: +49 89 329 8986 1502Email: communications@itm-radiopharma.com ITM Media RequestsTrophic CommunicationsStephanie May or Valeria FisherPhone: +49 171 185 56 82Email: itm@trophic.eu Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: Ben.Orzelek@itm-radiopharma.com About ITM Isotope Technologies Munich SEExecutive Board: Steffen Schuster (CEO), Dr. Klaus Maleck (CFO), Dr. Sebastian Marx (CBO) - Supervisory Board: Udo J Vetter (Chairman) - Registered Office: Garching/Munich -District Court of Munich - Commercial Register 269592 - Phone: +49 (0)89 329 8986 6000 - Fax: +49 (0)89 329 8986 6061 - Email: info@itm-radiopharma.comTax Number: 143/100/82466 - VAT Number: DE813228901 - Deutsche Bank Freiburg - IBAN: DE52680700300022816300 - BIC: DEUTDE6F Attachments ITM CBO Announcement 2022 CBO Sebastian Marx

抗体小分子药物

2022-07-21

·GlobeNewswire-Health Care

ITM Signs Clinical Supply Agreement with Y-mAbs for n.c.a. Lutetium-177

ITM to supply its medical radioisotope, no-carrier-added Lutetium-177, for the clinical development of Y-mAbs’ Targeted Radionuclide Therapy candidate GD2-SADA: 177Lu-DOTA Complex for GD2-positive solid tumors Garching / Munich, Germany, July 21, 2022 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the signing of a clinical supply agreement for its medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu / EndolucinBeta®) with Y-mAbs Therapeutics, Inc. (Y-mAbs), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. Under the terms of the agreement, ITM will provide its n.c.a. 177Lu for the clinical development of Y-mAbs’ radiopharmaceutical candidate GD2-SADA: 177Lu-DOTA Complex. GD2-SADA is currently in the preclinical development for the treatment of GD2-positive solid tumors, with a phase I study planned for 2022. GD2 (Disialoganglioside 2) is a tumor-associated antigen overexpressed by various tumor types, such as malignant melanoma, sarcoma, and small cell lung cancer, and used as a target for Targeted Radionuclide Therapy, potentially a precise approach being developed to directly destroy tumor tissue with minimal impact to surrounding healthy tissue. The radiopharmaceutical candidate GD2-SADA: 177Lu-DOTA Complex, is a two-step radioimmunotherapy, administered as an IV infusion. The 177Lu-DOTA Complex consists of a chelator (DOTA) and ITM’s medical radioisotope n.c.a. 177Lu and targets the previously administered tumor-binding antibody construct GD2-SADA enabling the delivery of the therapeutic radiation of n.c.a. 177Lu to the tumor-site in order to destroy the malignant cells. “GD2-positive solid tumors include a wide range of tumor types, and we believe the Y-mAbs approach can potentially offer a promising treatment option for patients who are affected by these cancers. We are proud to contribute to the company’s candidate development with our highly pure n.c.a. 177Lu,” comments Steffen Schuster, CEO of ITM. “We are committed to providing high-quality radioisotopes not only to our own radiopharmaceutical pipeline, but also to our partners to offer improved precision oncology treatments to healthcare professionals and their patients to the greatest extend possible.” N.c.a. 177Lu is a market-approved, highly pure form of the beta-emitting radioisotope lutetium-177 that can be linked to a variety of tumor-specific targeting molecules for the treatment of various cancers and has been successfully used in numerous clinical and commercial radiopharmaceutical cancer treatments. The agreement was executed between Y-mAbs and ITM’s wholly owned subsidiary ITM Pharma Solutions GmbH. - End - About Targeted Radionuclide Therapy Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, like receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization enables targeted treatment with minimal impact to healthy surrounding tissue. About ITM Isotope Technologies Munich SE ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com ITM Contact Corporate Communications Julia Hofmann / Susanne KarlssonPhone: +49 89 329 8986 1502Email: communications@itm-radiopharma.com ITM Media RequestsTrophic CommunicationsStephanie May or Valeria FisherPhone: +49 171 185 56 82Email: itm@trophic.eu Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: Ben.Orzelek@itm-radiopharma.com About ITM Isotope Technologies Munich SEExecutive Board: Steffen Schuster (CEO), Dr. Klaus Maleck (CFO) - Supervisory Board: Udo J Vetter (Chairman) - Registered Office: Garching/MunichDistrict Court of Munich - Commercial Register 269592 - Phone: +49 (0)89 329 8986 6000 - Fax: +49 (0)89 329 8986 6061 - Email: info@itm-radiopharma.comTax Number: 143/100/82466 - VAT Number: DE813228901 - Deutsche Bank Freiburg - IBAN: DE52680700300022816300 - BIC: DEUTDE6F Attachment PR_ITM-YMABS_Clinical-Supply-Agreement-Lutetium

合作抗体免疫疗法小分子药物

2022-07-13

·BioSpace

PLEXIUM APPOINTS BRIAN WONG, M.D., PH.D., TO ITS BOARD OF DIRECTORS

SAN DIEGO, July 13, 2022 /PRNewswire/ -- Plexium, Inc. (Plexium), a leading next-generation targeted protein degradation (TPD) company, today announced the appointment of Brian Wong as a member of its Board of Directors. Dr. Wong is a well-respected leader with more than two decades of experience in the biotechnology and large pharmaceutical sectors, including a track record of advancing more than 20 programs from discovery to late-stage clinical development and including through approval. "We are very pleased to have such an accomplished executive and drug developer like Brian join our Board as we continue to advance our TPD pipeline toward the clinic and to patients in need," said Plexium President & CEO Percival Barretto-Ko. "His diverse background as an industry executive in both small and large companies, combined with his training as a physician-scientist, will provide us with valuable insights as we develop our platform, grow our pipeline and unlock the potential of our Targeted Protein Degradation capabilities to improve the lives of patients." Dr. Wong currently serves as the President and CEO of RAPT Therapeutics, a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Prior to RAPT, Dr. Wong served as Senior Vice President, Research, and Head of Immuno-Oncology at Five Prime Therapeutics and as Director in the Inflammation Disease Biology Area at Roche. While at Roche, he led the discovery and development of Roche's autoimmune disease portfolio, consisting of more than 20 biologics and small-molecule programs from discovery to late-stage clinical development and through approval. Prior to Roche, he held various leadership roles at Rigel Pharmaceuticals, where he identified and developed clinical candidates for allergic, autoimmune and respiratory disorders, including Tavalisse™. Dr. Wong received his M.D. from the Weill Cornell Medical College and his Ph.D. in Immunology from Rockefeller University. "Plexium has tremendous potential to address the limitations of heterobifunctional degraders and cereblon IMiDs to create the next generation of Targeted Protein Degradation therapies," commented Dr. Wong. "In just a few short years, Plexium has executed on a thoughtful and purposeful strategy that I believe will build long-term value for all stakeholders, including patients and their families, making this a compelling opportunity and an exciting time to join the Board of Directors. I look forward to contributing to the Company's promising future as they advance novel TPD therapies toward the clinic." About Plexium Plexium is the premier, next-generation Targeted Protein Degradation (TPD) company seeking to discover a wide range of monovalent target protein degraders that address the limitations of heterobifunctional degraders and cereblon IMiDs. The company is powered by its proprietary drug discovery platform designed to identify novel small molecules that induce selective degradation of drug target proteins through E3 ligase mediated proteasomal degradation. From molecular glues to monovalent degraders, Plexium is advancing a pipeline of novel targeted protein degraders for the treatment of cancer, neurodegeneration, and other diseases. Due to its expertise in TPD, Plexium has entered into strategic collaborations with Amgen and AbbVie to discover and develop a wide range of new therapies from cancer to neurological diseases. Supported by high quality investors, Plexium is well positioned to transform medicine. For more information, visit and engage with us on LinkedIn. Plexium Investor and Media Contact: Amy Conrad Juniper Point amy@juniper-point.com 858-366-3243

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100 项与 Targeted Medical Pharma, Inc. 相关的转化医学

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