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:5/24/2017)... , May 24, 2017  ivWatch LLC ... Equipment Manufacturer (OEM) Board to enable seamless integration ... patient monitoring systems, infusion pumps and other devices. ... will be able to help health care customers ... reduced risks related to IV therapy. ...
(Date:5/18/2017)...  Bayer announced today that the latest research from ... the 53 rd Annual Meeting of the American ... in Chicago . ... liver and thyroid cancers, as well as lymphomas, and ... trial of copanlisib in patients with relapsed or refractory ...
(Date:5/10/2017)... Inc. (Nasdaq: HOLX ) announced today the ... April 1, 2017 .   GAAP diluted earnings per ... prior year period as the sale of the blood ... diluted EPS of $0.50 increased 6.4%.  Revenue of $715.4 ... Excluding the effects of blood screening and the acquired ...
Breaking Medicine Technology:
(Date:5/26/2017)... Boston, Massachsetts (PRWEB) , ... May 26, 2017 ... ... communities will gather at Boston CEO 2017 on May 30th and 31st at ... off-the-record networking forum for leading executives in the life sciences, offering exclusive access ...
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... ... premium delicatessen foods, is sharing bold recipes for Memorial Day entertaining that are ... menus. , “Boar’s Head fresh sliced meats and cheeses featured in these ...
(Date:5/26/2017)... ... May 26, 2017 , ... Silver Birch of Hammond, a ... located on more than four acres of land at 5620 Sohl Avenue in Hammond, ... 103,000 square-foot building includes 125 studio and one-bedroom apartments. Each of the private apartments ...
(Date:5/26/2017)... ... May 26, 2017 , ... Centennial-based BluSky Restoration Contractors ... its 14th Annual Clays for Kids fundraiser, to be held Friday, Sept. 22, ... , As part of BluSky’s partnership with The Adoption Exchange, BluSky will also ...
(Date:5/24/2017)... Ca (PRWEB) , ... May 24, 2017 , ... ... effects and background. Understanind and choosing the most appropriate instruments for research and ... critical in research finding. This webinar will focus on innovations in stereo microscopy ...
Breaking Medicine News(10 mins):