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Zsebo K.,Celladon | Yaroshinsky A.,AY Statistical Consulting | Rudy J.J.,Celladon | Wagner K.,Celladon | And 3 more authors.
Circulation Research | Year: 2014

Rationale: The Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease (CUPID 1) study was a phase 1/phase 2 first-in-human clinical gene therapy trial using an adeno-associated virus serotype 1 (AAV1) vector carrying the sarcoplasmic reticulum calcium ATPase gene (AAV1/SERCA2a) in patients with advanced heart failure. The study explored potential benefits of the therapy at 12 months, and results were previously reported. Objective: To report long-term (3-year) clinical effects and transgene expression in the patients in CUPID 1. Methods and results: A total of 39 patients with advanced heart failure who were on stable, optimal heart failure therapy were randomized to receive intracoronary infusion of AAV1/SERCA2a in 1 of 3 doses (low-dose, 6×1011 DNase-resistant particles; mid-dose, 3×10 12 DNase-resistant particles; and high-dose, 1×1013 DNase-resistant particles) versus placebo. The following recurrent cardiovascular and terminal events were tracked for 3 years in all groups: myocardial infarction, worsening heart failure, heart failure-related hospitalization, ventricular assist device placement, cardiac transplantation, and death. The number of cardiovascular events, including death, was highest in the placebo group, high but delayed in the low-and mid-dose groups, and lowest in the high-dose group. Evidence of long-term transgene presence was also observed in high-dose patients. The risk of prespecified recurrent cardiovascular events was reduced by 82% in the high-dose versus placebo group (P=0.048). No safety concerns were noted during the 3-year follow-up. Conclusions: After a single intracoronary infusion of AAV1/SERCA2a in patients with advanced heart failure, positive signals of cardiovascular events persist for years. © 2013 American Heart Association, Inc.


Receive press releases from iHealthcareAnalyst, Inc.: By Email Global Dilated Cardiomyopathy Therapeutics Market Analysis: Drug Classes, Clinical Pipeline and Forecast to 2020, New Report by iHealthcareAnalyst, Inc. Dilated Cardiomyopathy Therapeutics Market by Drug Classes (Aldosterone Antagonists, Angiotensin II Receptor Blockers, Angiotensin-Converting Enzyme Inhibitors, and Beta-Blockers) and Clinical Pipeline Analysis of Phase 1, 2 and 3 Drugs 2016-2020 Maryland Heights, MO, February 14, 2017 --( Browse Dilated Cardiomyopathy Therapeutics Market by Drug Classes (Aldosterone Antagonists, Angiotensin II Receptor Blockers, Angiotensin-Converting Enzyme Inhibitors, and Beta-Blockers) and Clinical Pipeline Analysis of Phase 1, 2 and 3 Drugs 2016-2020 at https://www.ihealthcareanalyst.com/report/dilated-cardiomyopathy-therapeutics-market/ Dilated cardiomyopathy (DCM) is also referred to as alcoholic cardiomyopathy, congestive, ischemic, primary cardiomyopathy, idiopathic, and peripartum cardiomyopathy. It is characterized by the enlargement of ventricular chamber along with systolic dysfunction. Dilated cardiomyopathy is the most common form of non-ischemic cardiomyopathy condition that involves decreased heart function due to an enlarged heart which cannot pump blood efficiently and can affect the lungs, liver, and other body systems. Dilated cardiomyopathy can develop at any age but it is more common among people aged between 20 years and 60 years. Standard therapy may include salt restriction, ACE inhibitors, diuretics, and digitalis and anticoagulants may also be used. The global dilated cardiomyopathy therapeutics market report estimates the market size (Revenue USD million - 2013 to 2020) for key market segments based on the drug classes (aldosterone antagonists, angiotensin ii receptor blockers, angiotensin-converting enzyme inhibitors, and beta-blockers) and clinical pipeline analysis of phase 1, 2 and 3 drugs, and forecasts growth trends (CAGR% - 2016 to 2020). The global dilated cardiomyopathy therapeutics market research report is further segmented by geography into North America (U.S., Canada), Latin America (Brazil, Mexico, Rest of LA), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), and Rest of the World. The global dilated cardiomyopathy therapeutics market report also provides the detailed market landscape, market drivers, restraints, opportunities), market attractiveness analysis and profiles of major competitors in the global market including company overview, financial snapshot, key products, technologies and services offered, and recent developments. Major players operating in the global dilated cardiomyopathy therapeutics market and included in this report are Array BioPharma, Inc., AstraZeneca plc, Celladon Corporation, GlaxoSmithKline plc, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novartis International AG, Pfizer, Inc., Teva Pharmaceutical Industries Ltd, and Vericel Corporation. To request Table of Contents and Sample Pages of this report visit: https://www.ihealthcareanalyst.com/report/dilated-cardiomyopathy-therapeutics-market/ About Us iHealthcareAnalyst, Inc. is a global healthcare market research and consulting company providing market analysis, and competitive intelligence services to global clients. The company publishes syndicate, custom and consulting grade healthcare reports covering animal healthcare, biotechnology, clinical diagnostics, healthcare informatics, healthcare services, medical devices, medical equipment, and pharmaceuticals. In addition to multi-client studies, we offer creative consulting services and conduct proprietary single-client assignments targeted at client’s specific business objectives, information needs, time frame and budget. Please contact us to receive a proposal for a proprietary single-client study. Contact Us iHealthcareAnalyst, Inc. 2109, Mckelvey Hill Drive, Maryland Heights, MO 63043 United States Email: sales@ihealthcareanalyst.com Website: https://www.ihealthcareanalyst.com Maryland Heights, MO, February 14, 2017 --( PR.com )-- The global dilated cardiomyopathy therapeutics market is estimated to reach USD 300 Million in 2020, declining at a CAGR of 6.0% from 2016 to 2020, due to significant increase in drug side effects and medical devices substitution worldwide.Browse Dilated Cardiomyopathy Therapeutics Market by Drug Classes (Aldosterone Antagonists, Angiotensin II Receptor Blockers, Angiotensin-Converting Enzyme Inhibitors, and Beta-Blockers) and Clinical Pipeline Analysis of Phase 1, 2 and 3 Drugs 2016-2020 at https://www.ihealthcareanalyst.com/report/dilated-cardiomyopathy-therapeutics-market/Dilated cardiomyopathy (DCM) is also referred to as alcoholic cardiomyopathy, congestive, ischemic, primary cardiomyopathy, idiopathic, and peripartum cardiomyopathy. It is characterized by the enlargement of ventricular chamber along with systolic dysfunction. Dilated cardiomyopathy is the most common form of non-ischemic cardiomyopathy condition that involves decreased heart function due to an enlarged heart which cannot pump blood efficiently and can affect the lungs, liver, and other body systems. Dilated cardiomyopathy can develop at any age but it is more common among people aged between 20 years and 60 years. Standard therapy may include salt restriction, ACE inhibitors, diuretics, and digitalis and anticoagulants may also be used.The global dilated cardiomyopathy therapeutics market report estimates the market size (Revenue USD million - 2013 to 2020) for key market segments based on the drug classes (aldosterone antagonists, angiotensin ii receptor blockers, angiotensin-converting enzyme inhibitors, and beta-blockers) and clinical pipeline analysis of phase 1, 2 and 3 drugs, and forecasts growth trends (CAGR% - 2016 to 2020). The global dilated cardiomyopathy therapeutics market research report is further segmented by geography into North America (U.S., Canada), Latin America (Brazil, Mexico, Rest of LA), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), and Rest of the World. The global dilated cardiomyopathy therapeutics market report also provides the detailed market landscape, market drivers, restraints, opportunities), market attractiveness analysis and profiles of major competitors in the global market including company overview, financial snapshot, key products, technologies and services offered, and recent developments.Major players operating in the global dilated cardiomyopathy therapeutics market and included in this report are Array BioPharma, Inc., AstraZeneca plc, Celladon Corporation, GlaxoSmithKline plc, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novartis International AG, Pfizer, Inc., Teva Pharmaceutical Industries Ltd, and Vericel Corporation.To request Table of Contents and Sample Pages of this report visit: https://www.ihealthcareanalyst.com/report/dilated-cardiomyopathy-therapeutics-market/About UsiHealthcareAnalyst, Inc. is a global healthcare market research and consulting company providing market analysis, and competitive intelligence services to global clients. The company publishes syndicate, custom and consulting grade healthcare reports covering animal healthcare, biotechnology, clinical diagnostics, healthcare informatics, healthcare services, medical devices, medical equipment, and pharmaceuticals.In addition to multi-client studies, we offer creative consulting services and conduct proprietary single-client assignments targeted at client’s specific business objectives, information needs, time frame and budget. Please contact us to receive a proposal for a proprietary single-client study.Contact UsiHealthcareAnalyst, Inc.2109, Mckelvey Hill Drive,Maryland Heights, MO 63043United StatesEmail: sales@ihealthcareanalyst.comWebsite: https://www.ihealthcareanalyst.com Click here to view the list of recent Press Releases from iHealthcareAnalyst, Inc.


Patent
Mount Sinai School of Medicine and Celladon | Date: 2011-04-14

The present invention provides methods for treating pulmonary hypertension in a subject by delivering a therapeutic adeno-associated virus (AAV)-SERCA2 composition to a subject in need thereof.


Patent
Mount Sinai School of Medicine and Celladon | Date: 2013-06-27

The present invention provides methods for treating pulmonary hypertension in a subject by delivering a therapeutic adeno-associated virus (AAV)-SERCA2 composition to a subject in need thereof.


The present invention relates to therapies for the treatment of cardiovascular diseases, particularly the delivery of therapeutic agents to heart tissue by direct infusion into the coronary circulation. A preferred embodiment of the invention is the use of a therapeutic polynucleotide composition adapted to transfect cardiac cells in the preparation of a medicament for treating or preventing cardiac disease by infusing the polynucleotide into a blood vessel of the coronary circulation over a period of at least three minutes, without isolating the coronary circulation from the systemic circulation. In a further preferred embodiment, the polynucleotide comprises a SERCA2a coding sequence packaged in a DNase resistant particle (DNP) of an AAV2/1 viral vector, the total number of DRP infused is less than or equal to 1 x 10^(13), and the blood vessel is the right or left coronary artery.


The present invention relates to improved therapies for the treatment of heart disease, particularly the improved delivery of therapeutic agents to heart tissue by direct infusion into the coronary circulation. A preferred embodiment of the invention is a method comprising, identifying a mammal in need of treatment or prevention of heart disease, and supplying NO to the coronary circulation prior to, and/or during the infusion of a therapeutic polynucleotide into a blood vessel of the coronary circulation in vivo.


The present invention relates to improved therapies for the treatment of heart disease, particularly the improved delivery of therapeutic agents to heart tissue by direct infusion into the coronary circulation. A preferred embodiment of the invention is a method of treating or preventing a cardiovascular disease by transfecting cardiac cells of a large mammal, the method comprising, identifying a mammal in need of treatment or prevention of heart disease, supplying NO to the coronary circulation prior to, and/or during the infusion of a therapeutic polynucleotide into a blood vessel of the coronary circulation in vivo, where the therapeutic polynucleotide is infused into the blood vessel over a period of at least about three minutes, where the coronary circulation is not isolated or substantially isolated from the systemic circulation of the mammal; and where the therapeutic polynucleotide transfects cardiac cells of the animal resulting in the treatment or prevention of the heart disease.


The present invention relates to methods for augmenting SERCA2 mediated calcium ion transport into the sarcoplasmic reticulum of cardiac myocytes of a host. The method includes administering to host cardiac myocytes a zinc finger protein that induces expression of SERCA2a (or administering a nucleic acid molecule encoding such a protein), wherein expression of SERCA2a produces an augmentation in SERCA2 mediated calcium ion transport in treated myocytes, as compared to untreated myocytes. Also provided are methods of treating heart failure by administering to a patient in need thereof, a zinc finger protein or zinc finger protein fused to an effector domain, that induces expression of SERCA2a.


BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces that it is investigating potential claims on behalf of investors Celladon Corporation (“Celladon” or the “Company”) (NASDAQ:CLDN) concerning the Company’s and its officers’ possible violations of federal securities laws. Celladon is a clinical-stage biotechnology company which is focused on the development of cardiovascular gene therapy and calcium dysregulation. The Company’s lead candidate is MYDICAR to treat inadequate pumping in heart failure patients. The investigation concerns whether the Company potentially misled investors regarding the design of its MYDICAR clinical trials; and otherwise misled investors regarding the successful FDA approval of MYDICAR. On April 26, 2015, Celladon issued a press release announcing that the Company’s Phase 2b CUPID2 trial of MYDICAR did not meet its primary and secondary goals. As a result of this news, the price of Celladon stock plummeted $11.04 per share to close at $2.64 per share on April 27, 2015, a decline of 80% on volume of 32 million shares. On June 1, 2015, Celladon issued a press release announcing the abrupt resignation of defendant Krisztina M. Zsebo (“Zsebo”) as Chief Executive Officer (“CEO”) and a director. Then, on June 26, 2015, before the market opened, Celladon issued a press release announcing the suspension of its plans for further research or development of its MYDICAR program and other pre-clinical programs, and indicating the possibility that the Company could be liquidated with net cash available to shareholders of $25-$30 million. As a result of this news, the price of Celladon stock dropped $0.85 per share to close at $1.35 per share on June 26, 2015, a decline of 38% on volume of 9 million shares. If you purchased shares of Celladon, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at http://www.howardsmithlaw.com. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.


LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP (“GPM”) announces the filing of a class action lawsuit on behalf of investors of Celladon Corporation (“Celladon” or the “Company”) (NASDAQ:CLDN), who purchased shares between July 7, 2014 and June 25, 2015, inclusive (the “Class Period”). Celladon investors have until August 31, 2015 to file a motion to serve as lead plaintiff in the class action. Celladon is a clinical-stage biotechnology company which is focused on the development of cardiovascular gene therapy and calcium dysregulation. The Company’s lead candidate is MYDICAR to treat inadequate pumping in heart failure patients. The complaint alleges that the Company potentially misled investors regarding the design of its MYDICAR clinical trials; and otherwise misled investors regarding the successful FDA approval of MYDICAR. On April 26, 2015, Celladon issued a press release announcing that the Company’s Phase 2b CUPID2 trial of MYDICAR did not meet its primary and secondary goals. As a result of this news, the price of Celladon stock plummeted $11.04 per share to close at $2.64 per share on April 27, 2015, a decline of 80% on volume of 32 million shares. On June 1, 2015, Celladon issued a press release announcing the abrupt resignation of defendant Krisztina M. Zsebo (“Zsebo”) as Chief Executive Officer (“CEO”) and a director. Then, on June 26, 2015, before the market opened, Celladon issued a press release announcing the suspension of its plans for further research or development of its MYDICAR program and other pre-clinical programs, and indicating the possibility that the Company could be liquidated with net cash available to shareholders of $25-$30 million. As a result of this news, the price of Celladon stock dropped $0.85 per share to close at $1.35 per share on June 26, 2015, a decline of 38% on volume of 9 million shares If you purchased shares of Celladon during the Class Period, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Casey Sadler, of GPM, 1925 Century Park East, Suite 2100, Los Angeles, California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to shareholders@glancylaw.com, or visit our website at http://www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

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