Navigation Links
Intra-Cellular Therapies Announces Completion of Phase I Single Rising Dose Trial of First-in-Class Selective Phosphodiesterase 1 (PDE1) Inhibitor and Reports Top-line Safety and Pharmacokinetic Findings
Date:2/19/2013

NEW YORK, Feb. 19, 2013 /PRNewswire/ -- Intra-Cellular Therapies, Inc. ("ITI") today announced the completion of a Phase I single rising dose study of its phosphodiesterase 1 (PDE1) inhibitor, ITI-214.  ITI-214, a novel, first-in-class selective PDE1 inhibitor, was discovered by ITI and is in development under an exclusive collaboration with Takeda Pharmaceutical Company Limited for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS). 

The primary objectives of the Phase I study were to determine the safety, tolerability and pharmacokinetic profile of single oral doses of ITI-214 in healthy volunteers.  The study was conducted as a randomized, double-blind, placebo-controlled study in 70 subjects.  The results indicated that ITI-214 was safe and well-tolerated across a broad range of single oral doses.  Moreover, ITI-214 demonstrates a favorable pharmacokinetic profile consistent with once-a-day dosing. The study represents a significant milestone as it is the first demonstration of the safety of a PDE1 inhibitor in a Phase 1 clinical trial.

"We are pleased with the advancement of ITI-214 in clinical development," stated Sharon Mates , Ph.D., Chairman and Chief Executive Officer of Intra-Cellular Therapies.  "The data obtained for ITI-214 support its continued development for the treatment of Cognitive Impairment Associated with Schizophrenia and other neuropsychiatric and neurological disorders."

About Schizophrenia

Schizophrenia is a major neuropsychiatric disorder that affects over one percent of the world population with an illness that begins in late adolescence and lasts a lifetime. Its best known symptoms are "positive symptoms", which include hallucinations and delusions; but other mental functions are also affected, including social and motivational skills ("negative symptoms") and cognitive behaviors, like inattention and poor memory. Current antipsychotics are effective primarily on reducing positive symptoms but are largely ineffective at reducing negative and cognitive symptoms. The medical need in this disease area is enormous.

About PDE1 Inhibitors

These compounds are unique, orally available, investigational drugs being developed for the treatment of cognitive impairments accompanying schizophrenia and other neurological and neuropsychiatric disorders, including Alzheimer's disease, Attention Deficit Hyperactivity Disorder and Parkinson's disease. These compounds may also have the potential to improve motor dysfunction associated with these disorders. These compounds are very selective for the PDE1 subfamily relative to other PDE subfamilies. They have no known significant off target activities at other enzymes, receptors or ion channels.

About Intra-Cellular Therapies, Inc.

Intra-Cellular Therapies, Inc. (ITI) is a biopharmaceutical company that is developing novel drugs for the treatment of diseases and disorders of the Central Nervous System (CNS). The Company was formed in 2002 to exploit intracellular signaling pathways of the brain in its efforts to develop novel CNS therapeutics. The Company's initial efforts were built on the insights generated from the Nobel Prize winning science of Dr. Paul Greengard at The Rockefeller University, the scientific founder of ITI. Using novel technologies developed at ITI, the Company has developed a pipeline of drugs that have the potential to treat a wide range of diseases associated with the CNS. Additional information about ITI is available through its corporate website, www.intracellulartherapies.com.  

CONTACT:
Allen A. Fienberg , Ph.D., Vice President, Business Development, Intra-Cellular Therapies, Inc., +1-212-923-3344; or Lisa Burns (Investors), or Justin Jackson (Media), both of Burns McClellan, Inc., +1-212-213-0006, jjackson@burnsmc.com.

 


'/>"/>
SOURCE Intra-Cellular Therapies, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Grant Awarded to Study Novel Therapies for Muco-Obstructive Diseases Includes Studies on Cempras Solithromycin (CEM-101) in a Cystic Fibrosis Anti-inflammatory Model
2. Launch Of Premium-priced, Novel Targeted Therapies Will Drive Growth In The Acute Leukemia Markets Beginning In 2015
3. Generex Provides an Overview of its Cancer Immunotherapy Product, AE37, and Potential in Early Breast Cancer Given Current and Potential Future Therapies
4. The Treatment Landscape for Hepatocellular Carcinoma Will Change Dramatically Over the Next Ten Years Due to the Launch of New Therapies in the United States and EU5
5. Oncologists in the United States and Europe Indicate that Novel Chemotherapies Hold the Most Near-Term Promise for Improving Outcomes in Soft Tissue Sarcoma
6. Takeda Receives FDA Approval for Three New Type 2 Diabetes Therapies, NESINA (alogliptin) and Fixed-Dose Combinations OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl)
7. Oncobiologics and Boston Oncology Team Up to Deliver Biosimilar Therapies for Cancer and Immune Disease to Middle East and North African Markets
8. Chimerix Presents Data Highlighting Burden Of Care Associated With Current Antiviral Therapies In Stem Cell Transplantation
9. Growing Prevalence of Asthma is Fueling Vigorous Industry Competition for Effective, Affordable Therapies
10. Neurostimulation Devices Market to 2018 - Technological Advances and Robust Pipeline with Multi-Indication Potential and Non-Invasive Therapies to Drive Growth
11. Multi-Targeted Therapies - New Wave of Combination Therapies in Late Stage Development for Lung Cancer Offer Promise
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016  Guerbet announced today that ... Supplier Horizon Award . One of ... was recognized for its support of Premier members through ... clinical excellence, and commitment to lower costs. ... this recognition of our outstanding customer service from Premier," ...
(Date:6/23/2016)... Research and Markets has announced the addition ... States, China, Japan, Brazil, United Kingdom, Germany, France, Italy, ... Surgical Procedure Volumes: Global ... surgical procedure volume data in a geographic context. The ... of growth drivers and inhibitors, including world population growth, ...
(Date:6/23/2016)... NEW YORK , June 23, 2016 ... rough waters, but it continues to present great opportunities ... featured companies for today: Intrexon Corp. (NYSE: ... ), Arena Pharmaceuticals Inc. (NASDAQ: ARNA ), ... Learn more about these stocks and receive your complimentary ...
Breaking Medicine Technology:
(Date:6/24/2016)... Diego, CA (PRWEB) , ... June 24, 2016 , ... ... with the American Cancer Society and the Road To Recovery® program to drive cancer ... to seniors and other adults to ensure the highest quality of life and ongoing ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their pencils ... an essay contest in which patients and their families pay tribute to a genetic ... 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... is proud to recognize Dr. Barry M. Weintraub as a prominent plastic surgeon ... beautiful women in the world, and the most handsome men, look naturally attractive. ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the Frederick area economy by obtaining investment capital for emerging technology companies. ... years that have already resulted in more than a million dollars of capital ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) sponsors Luke’s ... June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. ... helping service members that have been wounded in battle and their families. Venture Construction ...
Breaking Medicine News(10 mins):