Navigation Links
SemBioSys submits IND for safflower-produced insulin to U.S. FDA
Date:7/29/2008

- Submission demonstrates progress of plant-derived insulin program

scheduled to enter the clinic later this year -

TSX symbol: SBS

CALGARY, July 29 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, today announced that it has submitted an Investigational New Drug (IND) application for safflower-produced recombinant human insulin to the United States Food and Drug Administration (FDA). The IND application contains a physical, chemical and structural analysis of safflower-produced insulin to a reference standard, results from 28-day sub-chronic toxicology studies in two species of mammals, demonstration of pharmacodynamic function in animals and describes a cGMP process for the production of safflower-produced insulin. SemBioSys plans to initiate a Phase I/II clinical study of its safflower-produced insulin in the fourth quarter of 2008.

"The submission of the IND is a critical step toward the initiation of a Phase I/II clinical trial with our recombinant human insulin produced from safflower. All of our studies to date confirm that our safflower-produced insulin is equivalent to pharmaceutical-grade human insulin. We met our internal schedule to submit the IND and we are on track to begin human clinical trials in the fourth quarter of 2008 as planned," said Andrew Baum, president and chief executive officer of SemBioSys. "While we intend to initiate our first clinical trial for insulin in the UK, a successful IND application will provide us with the opportunity to consult the FDA on later stage clinical development. We believe this will allow us to apply for European and U.S. approvals for our safflower-produced insulin simultaneously."

SemBioSys also intends to submit a Clinical Trial Application (CTA) to the appropriate European authorities later this quarter. Assuming approval of the CTA, SemBioSys i
'/>"/>

SOURCE SemBioSys Genetics Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. SemBioSys updates Apo AI development program
2. SemBioSys to present insulin data at the Seventh Annual Diabetes Technology Meeting
3. SemBioSys announces 2007 third quarter results
4. SemBioSys signs option agreement for safflower-produced food ingredient
5. SemBioSys to present at the 10th Annual BIO CEO & Investor Conference
6. SemBioSys awarded key patent for the production of oleosome emulsions by the European Patent Office
7. SemBioSys GLA Partner Enters Strategic Alliance for the Sales and Marketing of GLA-Rich Safflower Oil
8. SemBioSys announces 2007 financial and operational results
9. SemBioSys initiates toxicology study for safflower-produced insulin
10. SemBioSys receives milestone payments from AVAC Ltd.
11. SemBioSys announces first quarter 2008 financial and operational results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... RBJ today announces the firm brokered a long-term lease totaling ... biopharmaceutical company, at Two Ledgemont Center in Lexington, ... president, and Brian Cohen , senior vice president, represented ... 95 Hayden Ave. Photo - http://photos.prnewswire.com/prnh/20150122/170765 ...
(Date:1/22/2015)... 2015 Crystal Diagnostics (CDx) Xpress System, a ... received AOAC-PTM Certifications for the six non-O157 Shiga toxin-producing E. ... referred to as STEC or the “Big-6”) as well as ... (cfu) per 325 g of raw ground beef and raw ...
(Date:1/22/2015)... 2015 Controlled Substance Compliance Services (CSCS), ... companies check the legal requirements around using controlled substances ... , As their international operations expand and become ... solutions built as a result of the first phase ...
(Date:1/22/2015)... , Jan. 22, 2015   Cypher Genomics, Inc., ... Inc. (NASDAQ: SQNM ), the leading ... for next generation noninvasive prenatal tests (NIPT). Through ... technology, called Mantis™, to advance analysis of clinically-relevant ...
Breaking Biology Technology:Transwestern?RBJ Advises Shire in 202,000 SF Lease, Creating Boston's Largest Suburban Biotech Campus 2Crystal Diagnostics Awarded AOAC-PTM Accreditation for the Rapid Detection of “Big 6” E.coli Food Pathogens 2Global Compliance Service for Controlled Substances to Expand to China 2Cypher Genomics and Sequenom Announce Development Agreement 2Cypher Genomics and Sequenom Announce Development Agreement 3Cypher Genomics and Sequenom Announce Development Agreement 4
... HILL, N.C., May 30 Given the increasing,challenges ... continue to seek external opportunities to grow their ... experts have,found the importance of proper integration of ... in the newly published study, "M&A Integration,Excellence: What ...
... N.J., May 30 Pharmacopeia (Nasdaq:,PCOP), an innovator ... therapeutics, announced today that it is implementing the ... resources on the company,s clinical,and later-stage discovery programs. ... 15 percent through attrition and,termination of positions as ...
... PCYC ) today announced that it has received ... regained compliance with Marketplace Rule,4450(a)(5) (the "Rule") relating to ... Company,s common stock. Nasdaq had previously notified the,company on ... to maintain a,minimum bid price of at least $1.00 ...
Cached Biology Technology:Bio-Pharma Industry Experts Deliver M&A Value Through Integration Excellence 2Pharmacopeia Advances Strategic Plan to Focus Resources on Development and Later-Stage Discovery Programs 2Pharmacopeia Advances Strategic Plan to Focus Resources on Development and Later-Stage Discovery Programs 3Pharmacopeia Advances Strategic Plan to Focus Resources on Development and Later-Stage Discovery Programs 4
(Date:12/17/2014)... 2014  HITLAB SM announced today its completion of ... adherence to current U.S. Food and Drug Administration (FDA) ... device and smart phone application trials utilizing the highest ... "HITLAB is determined to improve global healthcare access, quality, ...
(Date:12/17/2014)... DENVER , Dec. 16, 2014  Automation is fundamentally ... evident than at international borders. Over the past decade, ... veteran travelers to self process through border control via ... increasing number of airports, seaports, and land borders across ...
(Date:12/11/2014)... 09, 2014 Research and Markets , ... ) has announced the addition of the "Biometrics ... One major trend emerging in this ... biometric systems utilize more than one characteristic of an ...
Breaking Biology News(10 mins):HITLAB Completes GCP Audit for FDA Smart Device & App Compliance 2Automated Border Control (ABC) Transforms the Global Travel Experience With More Than 2500 ABC eGates and APC Kiosks Deployed In Airports, Seaports, and Land Borders Worldwide 2Biometrics Market in India 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2
... New Rochelle, NY, May 18, 2011Many gene therapy strategies designed ... carrying a disease-causing genetic mutation rely on a modified virus ... platform that is well suited for in vivo delivery of ... novel therapies move closer to commercialization, so do the methods ...
... genetic ,wiring, that helps a seed to decide on the ... the first time. Plant biologists at The University of ... germination is responsible for another important decision in the life ... discovery throws light on the genetic mechanisms that plants use ...
... University of Sheffield have developed pigment-free, intensely coloured polymer ... or banknotes due to their difficulty to copy. ... exhibit intense colour due to their structure, similar to ... butterfly wings. These colours were created by highly ...
Cached Biology News:Gene therapy success depends on ability to advance viral delivery vectors to commercialization 2Nottingham scientists reveal genetic 'wiring' of seeds 2Rainbows without pigments offer new defense against fraud 2
... The product contains 5 ml Dynabeads ... with p-toluenesulphonyl (tosyl) reactive groups. For coupling ... absorbed hydrophobically on initial coupling with covalent ... and sulphydryll groups (SH)) occurringovernight. Coupling ...
cysteine and glycine-rich protein 2,...
... pan B (B220), 4.5 m, coated ... efficient positive isolation or depletion of ... or lymph node cell suspensions. B220 ... cells and lytically active subsets of ...
Gap junction protein, beta 2, 26kDa (connexin 26) Antigen: Peptide...
Biology Products: