Navigation Links
Biodel Reports Top-Line Results From Pump Study of Experimental Insulins
Date:9/27/2011

DANBURY, Conn., Sept. 27, 2011 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) today announced top-line results from a Phase 1 clinical trial of BIOD-105 and BIOD-107 at Oregon Health and Sciences University to evaluate the pharmacokinetic, pharmacodynamic and infusion site tolerability profiles of these ultra-rapid-acting formulations of recombinant human insulin, relative to Humalog®, when delivered by insulin pumps.    

The trial was a single-center, randomized, double-blind, three-period crossover trial in 8 subjects with Type 1 diabetes.  Each study drug was administered on separate days.  Pharmacodynamics were assessed using the euglycemic clamp method.  Local infusion site discomfort was measured with a 100 mm visual analog scale and patient questionnaires.  

In this study, BIOD-105 and BIOD-107 demonstrated slightly more rapid absorption (as reflected by the mean time to 50% maximal insulin concentration), and markedly slower declines from peak effect than Humalog® with no significant differences among the three drugs regarding infusion site toleration.  The two Biodel formulations did not meet the company's target product profile and, therefore, will not be advanced into Phase 2 clinical testing.

Dr. Alan Krasner, Biodel's chief medical officer, stated: "These results are similar to what we observed in a previous Phase 1 study reported last month and indicate that we have achieved comparable tolerability to Humalog®, but they do not support further development of these candidates at this time."  

Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "The findings from these studies have been instructive as we continue to pursue our ultra-rapid-acting prandial insulin development program.  Last month we reported our exciting data on the development of analog-based ultra-rapid-acting insulin formulations and we continue to aggressively implement our two-pronged strategy of developing ultra-rapid-acting prandial formulations of both recombinant human insulin and insulin analogs. We plan to provide an update on our product development plans and timelines in the fourth calendar quarter of 2011." 

Dr. De Souza will present a company update today at 8:30 a.m. ET at the 6th Annual JMP Securities Healthcare Conference in New York.  To listen to the live webcast or a replay of the presentation, please visit the Investors section of the company's website at www.biodel.com.  A replay will be available for 90 days after the event.

About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients.  We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles.  For further information regarding Biodel, please visit the company's website at www.biodel.com.  

BIOD-G

Contact: Seth D. Lewis, +1-646-378-2952


'/>"/>
SOURCE Biodel Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Biodel Inc. Expands Ongoing Phase III VIAject(TM) Clinical Trials Into Europe
2. Biodel Inc. Completes Enrollment of Two Pivotal Phase III Clinical Trials of VIAject(TM) and Plans Manufacturing Facility for VIAject(TM)
3. Biodel Inc. Announces the Completion of Its Two Pivotal Trials and the Release of EASD Abstracts Containing Additional Interim Data From Its VIAject(TM) Program
4. Biodel Announces Schedule for Presentations at the 37th Annual Meeting and Exposition of the Controlled Release Society
5. Biodel to Raise $9.4 Million Through Registered Direct Offering
6. Biodel Appoints Arthur Urciuoli to its Board of Directors
7. Biodel Reports Research Progress in Poster Session on Short-Acting Insulins at 46th EASD Annual Meeting
8. Biodel to Present at Upcoming Conferences
9. FDA Issues Complete Response Letter to Biodel Regarding New Drug Application for Linjeta™
10. Biodel Awarded $1.2 Million in Therapeutic Discovery Research Grants From IRS
11. Biodel to Present Data from Product Development Programs at 2010 Diabetes Technology Meeting
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)... 2016 Research and Markets has ... Global Analysis (United States, China, Japan, Brazil, United Kingdom, ... their offering. Surgical ... business planners, provides surgical procedure volume data in a ... an in-depth analysis of growth drivers and inhibitors, including ...
(Date:6/23/2016)... , June 23, 2016 The ... it continues to present great opportunities to investors. Stock-Callers.com ... today: Intrexon Corp. (NYSE: XON ), Vertex ... Inc. (NASDAQ: ARNA ), and Regeneron Pharmaceuticals ... these stocks and receive your complimentary trade alerts at: ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their ... Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. , ... Pro X users can now reveal the media of their split screens with ...
(Date:6/26/2016)... ... ... Quality metrics are proliferating in cancer care, and are derived from many ... the beholder, according to experts who offered insights and commentary in the current issue ... the full issue, click here . , For the American Society of Clinical ...
(Date:6/26/2016)... ... June 26, 2016 , ... ... have been diagnosed with endometriosis. These women need a treatment plan to not ... comprehensive approach that can help for preservation of fertility and ultimately achieving a ...
(Date:6/25/2016)... ... 25, 2016 , ... First Choice Emergency Room , the largest network ... the Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased ... location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/24/2016)... ... 2016 , ... A recent article published June 14 on E ... goes on to state that individuals are now more comfortable seeking to undergo not ... as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians ...
Breaking Medicine News(10 mins):