Navigation Links
Cebix Initiates Phase 1b Clinical Trial with Drug Candidate Ersatta™
Date:6/16/2011

LA JOLLA, Calif., June 16, 2011 /PRNewswire/ -- Cebix Incorporated announced today it is advancing the development of modified C-peptide for the treatment of complications of diabetes. The biopharmaceutical company has initiated a Phase 1b clinical trial to evaluate Ersatta™, its proprietary long-acting form of C-peptide, in patients with type 1 diabetes who, because of their disease, lack this endogenous peptide.  Following the successful completion of this study, the company is planning a mid-stage clinical program in diabetic peripheral neuropathy and other chronic conditions associated with diabetes that may be reversed by replacing C-peptide.

The primary objectives of the randomized, blinded, placebo-controlled Phase 1b study are to assess the safety, tolerability as well as single and multiple dose pharmacokinetics of Ersatta after subcutaneous administration.  The study is estimated to enroll 30-60 patients and will be conducted at up to six sites in the U.S.  

Ersatta, a proprietary, mono-pegylated version of C-peptide, has improved pharmacokinetic properties compared to the native peptide. Pegylation of C-peptide extends the drug half-life, allowing for once-weekly dosing, which enhances patient compliance. Ersatta has been shown to improve nerve function in preclinical studies in a rat diabetic neuropathy model. Cebix has defined the pathway to marketing approval for Ersatta under U.S. Food and Drug Administration (FDA) subpart H. Nerve conduction velocity will therefore be the sole primary endpoint for a Phase 2/3 pivotal trial in diabetic peripheral neuropathy, which Cebix plans to initiate in the first half of 2012. Cebix has been granted fast track status by FDA for Ersatta in the diabetic peripheral neuropathy indication.

To date, Cebix has raised $30.5 million in Series A financing and established a database of 19 clinical studies evaluating native C-peptide in more than 300 patients with ty
'/>"/>

SOURCE Cebix Incorporated
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial Due to Particulates
2. Sangart Initiates Phase 2b Study of Oxygen Therapeutic Agent MP4OX in Severe Trauma Patients With Hemorrhagic Shock
3. Masimo Initiates Limited Market Release of E1, Single-Patient-Use Ear Sensor for Pulse Oximetry Monitoring
4. Tigris Pharmaceuticals Initiates Randomized Phase 2 Study of AFP-464 in ER-Positive Breast Cancer Patients
5. American Regent Initiates Nationwide Voluntary Recall of Sterile Water for Injection, USP, 50 mL Single Dose Vial Due to Particulate Matter
6. ViroPharma Initiates Phase 2 Study of VP 20621 for Prevention of Recurrence of Clostridium difficile Infection (CDI)
7. BAETA Corp Initiates Clinical Trial at NYU School of Medicine to Measure Efficacy of Pain Recording Device
8. Vista Partners Initiates Coverage on Helix BioPharma Corporation; Target Price $6.20
9. Independent Investigator Initiates Phase 1 Study of Biodels Ultra-Rapid-Acting Insulin Formulations in Patients Using Insulin Pumps
10. American Regent Initiates Nationwide Voluntary Recall of Caffeine & Sodium Benzoate Injection, USP 250 mg/mL, 2 mL Single Dose Vial Due to Visible Particulates
11. Selexys Pharmaceuticals Initiates Enrollment in Phase I Clinical Study of SelG1
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... Oct. 22, 2014  Paper Pak Industries, a ... APLS ® Body Guard Bio, a disposable, ... of bacteria and virus while protecting service providers ... Bio features a rugged, external nylon shell, watertight ... a leak-proof inner chamber that contains contaminated and ...
(Date:10/22/2014)... JERUSALEM , October 22, 2014 ... http://www.oramed.com ), a clinical-stage pharmaceutical company focused ... today reported positive top-line clinical results from its ... proprietary oral insulin capsules, to treat type 1 ... United States under a U.S. Food ...
(Date:10/22/2014)... , Oct. 22, 2014   Surefire Medical , ... systems designed to maximize targeted delivery of embolization agents ... announce that oncologist John R. Daniels , MD ... Center, and surgical oncologist Steven C. Katz , ... the Company,s Scientific Advisory Board (SAB).    ...
Breaking Medicine Technology:New, State-Of-The-Art Body Bag Minimizes The Spread Of Bacteria And Virus 2Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes 2Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes 3Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes 4Surefire Medical's Scientific Advisory Board Expands, Broadens Clinical Trial Expertise 2
(Date:10/22/2014)... Cheap Hosting USA is among the most distinguished review ... that iPower ( http://www.best-cheap-hosting-usa.com/go/iPower/ ) is the best cheap ... , “iPower is one of the most reliable hosting ... of useful products for new and old clients. What’s ... and a number of features which will appeal to ...
(Date:10/22/2014)... CA (PRWEB) October 22, 2014 Lintelus, ... Cormier, Sr. Vice President of Sales, will be speaking ... upcoming Meetings Technology Expo on October 28, at the ... be hosting a booth as well as a Tech ... Lintelus Meeting can create a more engaging event experience. ...
(Date:10/22/2014)... HealthDay Reporter , TUESDAY, Oct. 21, 2014 (HealthDay ... only about half as likely as white women to become ... and the racial disparity persists even when donor eggs are ... patients became pregnant after IVF, compared to about 17 percent ... over two years to tease out the impact of race, ...
(Date:10/22/2014)... 21, 2014 (HealthDay News) -- Measures taken by Firestone ... Ebola-ravaged Liberia may have limited the spread of the ... The Firestone Natural Rubber Co. provides health services ... of nearby densely populated communities. Between Aug. 1 ... Ebola cases among those 80,000 people. That incidence rate ...
(Date:10/20/2014)... Orlando, Florida (PRWEB) October 20, 2014 ... fired-up former Gov. Charlie Crist made a brief fundraising ...  in Orlando on Thursday. , Fresh from a debate ... refused to take the stage for the first seven ... podium, the former governor described the incident in one ...
Breaking Medicine News(10 mins):Health News:Best Cheap Hosting USA Has Recently Announced The Best Cheap Web Hosting Companies In 2014 2Health News:Jay Cormier, Sr. Vice President of Sales for Lintelus, Speaks about Event Technology Integration at Meetings Technology Expo in NYC 2Health News:Black Women Fare Worse With Fertility Treatments, Study Says 2Health News:Black Women Fare Worse With Fertility Treatments, Study Says 3Health News:Tire Company Sets Standard for Ebola Care in Liberia: CDC 2Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 2Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 3
... counterfeit medicines, seized in the European Union in 2006, according ... 31 percent of all fake medicines seized in the EU ... (8). The three countries are responsible for more than 70 ... ,The seized fake medicines included Viagra, Cialis and Levitra but ...
... the monsoons making a grand entry into Kerala, tourist resorts ... The rainy season, experts say, is the best time ... in India, it has only in recent years that it ... especially in the months June-August. ,According to ayurveda ...
... A new pair of studies compare step counts needed ... and 2) a one-mile mark. Both studies are ... Sports Medicine (ACSM) Annual Meeting in New Orleans, and ... activity recommendations. ,The first study, funded by ...
... Group of Eight industrialized nations plan to unveil their ... during their upcoming 2007 summit , which is scheduled ... spokesperson, Ulrich Wilhelm, said at a news conference on ... commitments would be announced during the summit. ...
... developing acute rheumatic fever (ARF) and rheumatic heart disease ... notified of any new cases , according to new ... and the Cardiac Society of Australia and New Zealand. ... ARF and RHD are diseases of poverty that occur ...
... The mercury crossed the 44 degrees Celsius mark in Delhi ... hottest day of the season so far. ... recorded a maximum temperature of 44.1 degrees Celsius, three degrees ... Celsius. ,Delhi had recorded a maximum of 42.7 ...
Cached Medicine News:Health News:India Main Source of Counterfeit Medicines Seized in Europe 2Health News:India Main Source of Counterfeit Medicines Seized in Europe 3Health News:Ayurveda Resorts in Kerala Gear Up for the Monsoon Season 2Health News:Ayurveda Resorts in Kerala Gear Up for the Monsoon Season 3Health News:Step-Based Guidelines in New Pair of Studies 2Health News:G8 Members To Announce Plans To Increase HIV/AIDS Spending at Summit 2Health News:New Strategy To Tackle Rheumatic Heart Disease 2
... 2000 is an ... for automated 96-/384-well ... With its ability ... any routine liquid ...
... popular for high throughput dispensing. Multidrop ... and increased throughput, particularly for screening ... automated dispenser designed for high-throughput screening ... 96-well plates. This new-generation dispenser offers ...
... latest innovation in prostate mapping, ... Combining 3-D image acquisition with ... technology helps physicians plan and ... potentially improving patients' cancer treatment ...
RIA kit for the determination of binding autoantibodies to the acetylcholine receptor (AChR) in serum....
Medicine Products: