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Purpose: To test the performance of dual-energy computed tomography (CT) in the assessment of marrow adipose tissue (MAT) content of the lumbar spine by using proton (hydrogen 1 [1H]) magnetic resonance (MR) spectroscopy as a reference standard and to determine the influence of MAT on the assessment of bone mineral density (BMD). Materials and Methods: This study was institutional review board approved and complied with HIPAA guidelines. Written informed consent was obtained. Twelve obese osteopenic but otherwise healthy subjects (mean age 6 standard deviation, 43 years 6 13) underwent 3-T 1H MR spectroscopy of the L2 vertebra by using a point-resolved spatially localized spectroscopy sequence without water suppression. The L2 vertebra was scanned with dual-energy CT (80 and 140 kV) by using a dual-source multi-detector row CT scanner with a calibration phantom. Mean basis material composition relative to the phantom was estimated in the L2 vertebra. Volumetric BMD was measured with and without correction for MAT. Bland-Altman 95% limits of agreement and Pearson correlation coefficients were calculated. Results: There was excellent agreement between 1H MR spectroscopy and dual-energy CT, with a mean difference in fat fraction of 20.02 between the techniques, with a 95% confidence interval of 20.24, 0.20. There was a strong correlation between marrow fat fraction obtained with 1H MR spectroscopy and that obtained with dual-energy CT (r = 0.91, P , .001). The presence of MAT led to underestimation of BMD, and this bias increased with increasing MAT content (P , .001). Conclusion: Dual-energy CT can be used to assess MAT content and BMD of the lumbar spine in a single examination and provides data that closely agree and correlate with 1H MR spectroscopy data. © RSNA, 2015.


PubMed | OPKO BiologicsKiryat Gat, Charité - Medical University of Berlin, Internal Clinic in University Hospital St AnnaBrno, Ludwig Maximilians University of Munich and 2 more.
Type: Journal Article | Journal: European journal of endocrinology | Year: 2016

Growth hormone (GH) replacement therapy currently requires daily injections, which may cause distress and low compliance. C-terminal peptide (CTP)-modified growth hormone (MOD-4023) is being developed as a once-weekly dosing regimen in patients with GH deficiency (GHD). This studys objective is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of MOD-4023 administered once-weekly in GHD adults.54 adults with GHD currently treated with daily GH were normalized and randomized into 4 weekly dosing cohorts of MOD-4023 at 18.5%, 37%, 55.5% or 123.4% of individual cumulative weekly molar hGH dose. The study included 2 stages: Stage A assessed the effectiveness and PK/PD profiles of the 4 dosing regimens of MOD-4023. Stage B was an extension period of once-weekly MOD-4023 administration (61.7% molar hGH content) to collect further safety data and confirm the results from Stage A.Dose-dependent response was observed for both PK and PD data of weekly MOD-4023 treatment. Insulin-like growth factor I (IGF-I) SDS levels were maintained within normal range. The 18.5% cohort was discontinued due to low efficacy. MOD-4023 was well tolerated and exhibited favorable safety profile in all dose cohorts. The reported adverse events were consistent with known GH-related side effects.Once-weekly MOD-4023 administration in GHD adults was found to be clinically effective while maintaining a favorable safety profile and may obviate the need for daily injections. Weekly GH injections may improve compliance and overall outcome. The promising results achieved in this Phase 2 study led to a pivotal Phase 3 trial, which is currently ongoing.


News Article | November 10, 2016
Site: globenewswire.com

SAN DIEGO, Nov. 10, 2016 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals ("Crinetics"), an innovative therapeutics company focused on specialty endocrine disorders and endocrine-related cancers, announced today the addition of Anne Klibanski, M.D. as a member of the company's scientific advisory board. "I am excited to be a part of this growing team that is working to study and develop effective oral therapies for acromegaly and other neuroendocrine tumors," said Dr. Klibanski. "The ultimate goal is to find treatments and cures for the wide range of neuroendocrine diseases and improve the lives of patients suffering from these serious conditions." "We continue to assemble a world-class team with expertise in creating and developing innovative therapeutics for specialty endocrine disorders," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We are excited to welcome Dr. Klibanski to the scientific advisory board of Crinetics Pharmaceuticals. She is an internationally-recognized leader in neuroendocrinology and complements our team as we grow Crinetics into a clinical-stage therapeutics company." Dr. Klibanski is the director of the Neuroendocrine and Pituitary Tumor Clinical Center and chief of the Neuroendocrine Unit at Massachusetts General Hospital, and the Laurie Carrol Guthart Professor of Medicine at Harvard Medical School. She is a clinical researcher who studies pituitary tumor pathogenesis and the impact that pituitary and hypothalamic disorders have on body composition, including low bone mass.  Awards in recognition of her work have included The Endocrine Society Clinical Investigator Award and the British Trust Medal.  She is the author of more than 350 peer-reviewed publications and has served on the NIH NIDDK Board of Counselors and on the Editorial Board of the Journal of Clinical Endocrinology and Metabolism. She is past-president of the Pituitary Society and serves on its board. She has been involved in leadership positions of many educational programs sponsored by the Endocrine Society, the Pituitary Society, and many patient advocacy groups to teach physicians and patients about pituitary tumors and neuroendocrine disorders. She has a B.A. from Barnard College and an M.D. from New York University School of Medicine. About Crinetics Pharmaceuticals Crinetics Pharmaceuticals discovers and develops novel therapeutics targeting peptide hormone receptors for the treatment of specialty endocrine disorders and endocrine-related cancers. Its pioneering small molecule somatostatin agonist program for the treatment of acromegaly and neuroendocrine tumors aims to provide a convenient, more effective oral therapy for patients whose only current options are painful injected depot drugs. Crinetics was founded by a team of scientists with a proven track record of endocrine drug discovery and development to create important new therapeutic options for endocrinologists and their patients. The company is backed by top life sciences investors, 5AM Ventures, Versant Ventures, and Vivo Capital and is headquartered in San Diego. For more information, please visit www.crinetics.com.


News Article | November 10, 2016
Site: globenewswire.com

SAN DIEGO, Nov. 10, 2016 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals ("Crinetics"), an innovative therapeutics company focused on specialty endocrine disorders and endocrine-related cancers, announced today the addition of Anne Klibanski, M.D. as a member of the company's scientific advisory board. "I am excited to be a part of this growing team that is working to study and develop effective oral therapies for acromegaly and other neuroendocrine tumors," said Dr. Klibanski. "The ultimate goal is to find treatments and cures for the wide range of neuroendocrine diseases and improve the lives of patients suffering from these serious conditions." "We continue to assemble a world-class team with expertise in creating and developing innovative therapeutics for specialty endocrine disorders," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We are excited to welcome Dr. Klibanski to the scientific advisory board of Crinetics Pharmaceuticals. She is an internationally-recognized leader in neuroendocrinology and complements our team as we grow Crinetics into a clinical-stage therapeutics company." Dr. Klibanski is the director of the Neuroendocrine and Pituitary Tumor Clinical Center and chief of the Neuroendocrine Unit at Massachusetts General Hospital, and the Laurie Carrol Guthart Professor of Medicine at Harvard Medical School. She is a clinical researcher who studies pituitary tumor pathogenesis and the impact that pituitary and hypothalamic disorders have on body composition, including low bone mass.  Awards in recognition of her work have included The Endocrine Society Clinical Investigator Award and the British Trust Medal.  She is the author of more than 350 peer-reviewed publications and has served on the NIH NIDDK Board of Counselors and on the Editorial Board of the Journal of Clinical Endocrinology and Metabolism. She is past-president of the Pituitary Society and serves on its board. She has been involved in leadership positions of many educational programs sponsored by the Endocrine Society, the Pituitary Society, and many patient advocacy groups to teach physicians and patients about pituitary tumors and neuroendocrine disorders. She has a B.A. from Barnard College and an M.D. from New York University School of Medicine. About Crinetics Pharmaceuticals Crinetics Pharmaceuticals discovers and develops novel therapeutics targeting peptide hormone receptors for the treatment of specialty endocrine disorders and endocrine-related cancers. Its pioneering small molecule somatostatin agonist program for the treatment of acromegaly and neuroendocrine tumors aims to provide a convenient, more effective oral therapy for patients whose only current options are painful injected depot drugs. Crinetics was founded by a team of scientists with a proven track record of endocrine drug discovery and development to create important new therapeutic options for endocrinologists and their patients. The company is backed by top life sciences investors, 5AM Ventures, Versant Ventures, and Vivo Capital and is headquartered in San Diego. For more information, please visit www.crinetics.com.


News Article | November 10, 2016
Site: globenewswire.com

SAN DIEGO, Nov. 10, 2016 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals ("Crinetics"), an innovative therapeutics company focused on specialty endocrine disorders and endocrine-related cancers, announced today the addition of Anne Klibanski, M.D. as a member of the company's scientific advisory board. "I am excited to be a part of this growing team that is working to study and develop effective oral therapies for acromegaly and other neuroendocrine tumors," said Dr. Klibanski. "The ultimate goal is to find treatments and cures for the wide range of neuroendocrine diseases and improve the lives of patients suffering from these serious conditions." "We continue to assemble a world-class team with expertise in creating and developing innovative therapeutics for specialty endocrine disorders," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We are excited to welcome Dr. Klibanski to the scientific advisory board of Crinetics Pharmaceuticals. She is an internationally-recognized leader in neuroendocrinology and complements our team as we grow Crinetics into a clinical-stage therapeutics company." Dr. Klibanski is the director of the Neuroendocrine and Pituitary Tumor Clinical Center and chief of the Neuroendocrine Unit at Massachusetts General Hospital, and the Laurie Carrol Guthart Professor of Medicine at Harvard Medical School. She is a clinical researcher who studies pituitary tumor pathogenesis and the impact that pituitary and hypothalamic disorders have on body composition, including low bone mass.  Awards in recognition of her work have included The Endocrine Society Clinical Investigator Award and the British Trust Medal.  She is the author of more than 350 peer-reviewed publications and has served on the NIH NIDDK Board of Counselors and on the Editorial Board of the Journal of Clinical Endocrinology and Metabolism. She is past-president of the Pituitary Society and serves on its board. She has been involved in leadership positions of many educational programs sponsored by the Endocrine Society, the Pituitary Society, and many patient advocacy groups to teach physicians and patients about pituitary tumors and neuroendocrine disorders. She has a B.A. from Barnard College and an M.D. from New York University School of Medicine. About Crinetics Pharmaceuticals Crinetics Pharmaceuticals discovers and develops novel therapeutics targeting peptide hormone receptors for the treatment of specialty endocrine disorders and endocrine-related cancers. Its pioneering small molecule somatostatin agonist program for the treatment of acromegaly and neuroendocrine tumors aims to provide a convenient, more effective oral therapy for patients whose only current options are painful injected depot drugs. Crinetics was founded by a team of scientists with a proven track record of endocrine drug discovery and development to create important new therapeutic options for endocrinologists and their patients. The company is backed by top life sciences investors, 5AM Ventures, Versant Ventures, and Vivo Capital and is headquartered in San Diego. For more information, please visit www.crinetics.com.


News Article | November 10, 2016
Site: globenewswire.com

SAN DIEGO, Nov. 10, 2016 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals ("Crinetics"), an innovative therapeutics company focused on specialty endocrine disorders and endocrine-related cancers, announced today the addition of Anne Klibanski, M.D. as a member of the company's scientific advisory board. "I am excited to be a part of this growing team that is working to study and develop effective oral therapies for acromegaly and other neuroendocrine tumors," said Dr. Klibanski. "The ultimate goal is to find treatments and cures for the wide range of neuroendocrine diseases and improve the lives of patients suffering from these serious conditions." "We continue to assemble a world-class team with expertise in creating and developing innovative therapeutics for specialty endocrine disorders," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We are excited to welcome Dr. Klibanski to the scientific advisory board of Crinetics Pharmaceuticals. She is an internationally-recognized leader in neuroendocrinology and complements our team as we grow Crinetics into a clinical-stage therapeutics company." Dr. Klibanski is the director of the Neuroendocrine and Pituitary Tumor Clinical Center and chief of the Neuroendocrine Unit at Massachusetts General Hospital, and the Laurie Carrol Guthart Professor of Medicine at Harvard Medical School. She is a clinical researcher who studies pituitary tumor pathogenesis and the impact that pituitary and hypothalamic disorders have on body composition, including low bone mass.  Awards in recognition of her work have included The Endocrine Society Clinical Investigator Award and the British Trust Medal.  She is the author of more than 350 peer-reviewed publications and has served on the NIH NIDDK Board of Counselors and on the Editorial Board of the Journal of Clinical Endocrinology and Metabolism. She is past-president of the Pituitary Society and serves on its board. She has been involved in leadership positions of many educational programs sponsored by the Endocrine Society, the Pituitary Society, and many patient advocacy groups to teach physicians and patients about pituitary tumors and neuroendocrine disorders. She has a B.A. from Barnard College and an M.D. from New York University School of Medicine. About Crinetics Pharmaceuticals Crinetics Pharmaceuticals discovers and develops novel therapeutics targeting peptide hormone receptors for the treatment of specialty endocrine disorders and endocrine-related cancers. Its pioneering small molecule somatostatin agonist program for the treatment of acromegaly and neuroendocrine tumors aims to provide a convenient, more effective oral therapy for patients whose only current options are painful injected depot drugs. Crinetics was founded by a team of scientists with a proven track record of endocrine drug discovery and development to create important new therapeutic options for endocrinologists and their patients. The company is backed by top life sciences investors, 5AM Ventures, Versant Ventures, and Vivo Capital and is headquartered in San Diego. For more information, please visit www.crinetics.com.


News Article | November 10, 2016
Site: globenewswire.com

SAN DIEGO, Nov. 10, 2016 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals ("Crinetics"), an innovative therapeutics company focused on specialty endocrine disorders and endocrine-related cancers, announced today the addition of Anne Klibanski, M.D. as a member of the company's scientific advisory board. "I am excited to be a part of this growing team that is working to study and develop effective oral therapies for acromegaly and other neuroendocrine tumors," said Dr. Klibanski. "The ultimate goal is to find treatments and cures for the wide range of neuroendocrine diseases and improve the lives of patients suffering from these serious conditions." "We continue to assemble a world-class team with expertise in creating and developing innovative therapeutics for specialty endocrine disorders," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We are excited to welcome Dr. Klibanski to the scientific advisory board of Crinetics Pharmaceuticals. She is an internationally-recognized leader in neuroendocrinology and complements our team as we grow Crinetics into a clinical-stage therapeutics company." Dr. Klibanski is the director of the Neuroendocrine and Pituitary Tumor Clinical Center and chief of the Neuroendocrine Unit at Massachusetts General Hospital, and the Laurie Carrol Guthart Professor of Medicine at Harvard Medical School. She is a clinical researcher who studies pituitary tumor pathogenesis and the impact that pituitary and hypothalamic disorders have on body composition, including low bone mass.  Awards in recognition of her work have included The Endocrine Society Clinical Investigator Award and the British Trust Medal.  She is the author of more than 350 peer-reviewed publications and has served on the NIH NIDDK Board of Counselors and on the Editorial Board of the Journal of Clinical Endocrinology and Metabolism. She is past-president of the Pituitary Society and serves on its board. She has been involved in leadership positions of many educational programs sponsored by the Endocrine Society, the Pituitary Society, and many patient advocacy groups to teach physicians and patients about pituitary tumors and neuroendocrine disorders. She has a B.A. from Barnard College and an M.D. from New York University School of Medicine. About Crinetics Pharmaceuticals Crinetics Pharmaceuticals discovers and develops novel therapeutics targeting peptide hormone receptors for the treatment of specialty endocrine disorders and endocrine-related cancers. Its pioneering small molecule somatostatin agonist program for the treatment of acromegaly and neuroendocrine tumors aims to provide a convenient, more effective oral therapy for patients whose only current options are painful injected depot drugs. Crinetics was founded by a team of scientists with a proven track record of endocrine drug discovery and development to create important new therapeutic options for endocrinologists and their patients. The company is backed by top life sciences investors, 5AM Ventures, Versant Ventures, and Vivo Capital and is headquartered in San Diego. For more information, please visit www.crinetics.com.

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