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

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,  

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,


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:
(Date:12/1/2015)... , BANGALORE, India and ... N.V. (NASDAQ, TASE: MYL) today announced that it expects ... and for developing country markets funded by international donors, ... mg + Efavirenz 400 mg) for $99 per patient, ... Initiative (CHAI) to develop TLE400. The significantly reduced price ...
(Date:12/1/2015)... CARLSBAD, Calif. , Dec. 1, 2015 ... medicine products and services, announced today that it has ... care services organization. Members served by Novation will have ... therapy devices, sports bracing products and soft goods dedicated ... --> The aging U.S. population, rising ...
(Date:12/1/2015)... 2015 Building on its 25-year legacy ... (NYSE: JNJ ) today announced four new ... significantly reduce the burden of HIV incidence, especially ... of new HIV infections among adolescents in sub-Saharan ... these new initiatives include collaborations with the U.S. ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... 2015 , ... World Patent Marketing , a vertically integrated manufacturer ... for easier packing and organizing of items into one big, portable jar. , The ... CEO and Creative Director of World Patent Marketing and Desa Industries Inc . ...
(Date:12/1/2015)... ... December 02, 2015 , ... ClinicoEconomics ... association with initiation of treatment for osteoporosis ”. , As corresponding author Dr ... in patients diagnosed with osteoporosis. Based on a large US managed care database, ...
(Date:12/1/2015)... ... December 01, 2015 , ... Integrated Rental Services ... Jordan Industries International, LLC (“JII”). , With support from JII, Integrated Rental is ... to hospitals, surgery centers, clinics, research labs and medical facilities across the United ...
(Date:12/1/2015)... CA (PRWEB) , ... December 01, 2015 , ... According ... of obesity groups has filed a discrimination claim against the U.S. Department of Health ... in their Affordable Care Act (ACA) plans are breaking the clause in the law ...
(Date:12/1/2015)... ... 2015 , ... Baptist Medical Center Jacksonville has implanted the ... hospital in the region providing what is known as the world’s smallest pacemaker. ... revealed recently at a medical conference and published in The New England Journal ...
Breaking Medicine News(10 mins):