Navigation Links
Helix BioPharma Announces Q3 2009 Financial Results and Provides Product Development Update
Date:6/15/2009

on of such activities, the Company now expects its IND filing to occur within approximately six months of the previously anticipated date of July 31, 2009. The success of upcoming program efforts, including the remaining GMP scale-up production activities, the outcome of its upcoming pre-IND meeting and the outcome of the remaining non-clinical pharmacology and toxicology studies will ultimately determine the timing of Helix's Phase I/II IND/CTA filings.

Topical Interferon Alpha-2b Product Development Update - Cervical Displasia Indication ("LSIL")

During the quarter, Helix received regulatory approval to conduct its European Phase II pharmacokinetic study in human subjects prior to initiating its planned Phase IIb/III trials, and enrollment in the study is actively underway.

In parallel with its clinical progress, Helix has continued to advance its GMP production activities in anticipation of the Phase IIb and III trials in the United States and Europe respectively. Although all activities in preparation for the planned Phase IIb/III trials are progressing, the Company has experienced some delays associated with the GMP manufacturing scale-up program and in initiating the human pharmacokinetic study.

Helix is preparing to conduct a pre-IND meeting with the FDA to confirm its pivotal efficacy trial plans. Helix has submitted its formal meeting request, and is awaiting a reply from the authority confirming their timing availability. The outcome of this meeting along with the success of Helix's remaining GMP manufacturing scale-up and human pharmacokinetic study activities, will determine the timing of Helix's U.S. IND filing which was previously anticipated by July 31, 2009 but is now not expected before the end of Helix's fiscal 2010 first quarter ending October 31, 2009. The new expected timing of filing the confirmatory European Phase III Clinical Trial Application has not yet been establish
'/>"/>

SOURCE Helix BioPharma Corp.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Related biology technology :

1. Helix Biopharma announces addition of University of Arizona professor Kenneth Hatch as new medical advisor
2. Helix BioPharma Chairman resigns
3. Helix BioPharma Corp. announces fiscal 2007 results
4. Helix BioPharma Corp. announces management changes
5. Helix BioPharma announces $16.9 million private placement of common shares
6. Helix BioPharma announces Q1 2008 financial results
7. Helix BioPharma closes $16.9 million private placement of common shares
8. Helix BioPharma Corp. contracts KBI Biopharma to develop an L-DOS47 clinical packaging format
9. Helix BioPharma shareholders vote in favour of management
10. Helix BioPharma reports Q2 2008 highlights, financial results
11. W. Thomas Hodgson appointed to board of Helix BioPharma Corp.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... -- Egenix, Inc. is pleased to announce that Lionel ... to succeed Donald Fresne ; Mr. Fresne has also ... member of the Board.  In recognition of the many contributions ... almost twenty years, the Board designated Mr. Fresne as Chairman ... a Search Committee to find a suitable replacement with Biotech ...
(Date:12/17/2014)... 17, 2014 Based on the ... surgical imaging market is dominated by four major ... imaging market. These players include GE Healthcare (U.K.), ... (Germany). , Full Report Copy at ... Healthcare can be attributed to its strong product ...
(Date:12/17/2014)... Once more, EMAAR has selected ... waste water treatment plant to phase one of BayLaSun, ... Two years ago Bioshaft successfully supplied and operated a ... residential towers with an occupancy of 900 residences. ... gallons per day and was signed on September 16th, ...
(Date:12/17/2014)... December 17, 2014 Audacity, a leading ... and member of the Huntsworth Health Group, is proud ... executive team. In her role, Gonzales will serve as ... are incredibly honored to welcome a talent of Jamie’s ... CEO, Gaëtan Fraikin. “She is a proven healthcare innovation ...
Breaking Biology Technology:Global Refurbished Surgical Imaging Market by Product & Application is Estimated to Reach $1.25 Billion by 2019 - New Research Report by MarketsandMarkets 2Global Refurbished Surgical Imaging Market by Product & Application is Estimated to Reach $1.25 Billion by 2019 - New Research Report by MarketsandMarkets 3Global Refurbished Surgical Imaging Market by Product & Application is Estimated to Reach $1.25 Billion by 2019 - New Research Report by MarketsandMarkets 4Audacity Welcomes Healthcare Communications Expert Jamie Gonzales as Senior Vice President of Client Services 2
... 2012 Synthetic Genomics Inc. (SGI), a privately held ... range of global challenges, today announced they have purchased ... of newly identified and engineered algal strains. The company ... near the Salton Sea, to test algal strains isolated ...
... 24, 2012  Novocure™, a commercial stage private oncology company, ... of excellence will join the seven existing clinical centers ... patients with recurrent GBM. These fifteen clinical centers are ... GBM is both the deadliest and most ...
... 2012 Mylan Inc. (Nasdaq: MYL ) ... the company,s credit ratings, including the "Corporate Family Rating," ... outlook is stable.  According to Moody,s: ... position in the global generic pharmaceutical industry, its strong ...
Cached Biology Technology:Synthetic Genomics Inc. Purchases 81 Acre Site in South California Desert for Scale up and Testing of Innovative Algae Strains 2Novocure™ Certifies Eight Additional Clinical Centers of Excellence to Treat Most Common Brain Tumor with Tumor Treating Fields (TTFields) Therapy 2Novocure™ Certifies Eight Additional Clinical Centers of Excellence to Treat Most Common Brain Tumor with Tumor Treating Fields (TTFields) Therapy 3Novocure™ Certifies Eight Additional Clinical Centers of Excellence to Treat Most Common Brain Tumor with Tumor Treating Fields (TTFields) Therapy 4Moody's Upgrades Mylan 2
(Date:11/21/2014)... Nov. 19, 2014  Earlier this year Donald ... College, and one of the most prolific inventors in ... are transmitted from Smartphones to third party agencies. Spector ... has one of the earliest known patents in this ... in the military, child care, elder care and hospital ...
(Date:11/18/2014)... 18, 2014  The Secure Identity & Biometrics ... jointly announce the formation of The Airport Entry ... Identity and Biometric Entry and Exit Solutions ... official support from BORDERPOL, the international non-profit organization ... provide expertise regarding border security, traveler and migration ...
(Date:11/15/2014)... 13, 2014  While we may still be a few ... in "Star Trek" to gain instant access to all that ... with smartphones and tablets for monitoring and measuring our health ... This may seem a tad Orwellian to some, but a ... of these technological opportunities into their healthcare regime. ...
Breaking Biology News(10 mins):Patented Biosensor Wearable Technology Provides a More Civilized Method of Quarantine 2Patented Biosensor Wearable Technology Provides a More Civilized Method of Quarantine 3Patented Biosensor Wearable Technology Provides a More Civilized Method of Quarantine 4Identity Management, Document Authentication and Biometric Companies Form "The Airport Entry and Exit Working Group", Releasing the Framework to Help Guide the Department of Homeland Security and Congress Towards Solutions 2Identity Management, Document Authentication and Biometric Companies Form "The Airport Entry and Exit Working Group", Releasing the Framework to Help Guide the Department of Homeland Security and Congress Towards Solutions 3Americans May Be Ready for a Brave New World of Healthcare 2Americans May Be Ready for a Brave New World of Healthcare 3Americans May Be Ready for a Brave New World of Healthcare 4
... lobe dementia (Frontotemporal Dementia, FTD) strikes people at an earlier ... that occurs most frequently in patients younger than 65. In ... large numbers of brain cells begin to die off. The ... constitutes about 30% of the brain. Among other things, it ...
... re-emergence of a fungus that could cripple wheat production in ... wheat experts from around the world, led by Nobel Prize ... gather March 17-20 in Ciudad Obregn, Mexico, to map out ... provides food and livelihoods for hundreds of millions of people. ...
... Too little activity by gene regulators called PPARs appears ... damage that can occur in children with heart defects, ... under study to boost PPAR signaling in adults with ... balance of blood vessel dilation and contraction, preventing the ...
Cached Biology News:Blood test predicts chance of dementia 2Scientists gather to protect global food security from return of devastating wheat fungus 2Pulmonary hypertension in children may result from reduced activity of gene regulator 2Pulmonary hypertension in children may result from reduced activity of gene regulator 3
... This kit is designed for easy transformation ... protocol allows for successful transformation simply by ... reagents with cultured yeast cells. No complicated ... are required. The kit is particularly well ...
... The STag Purification Kits enable rapid analytical ... fusion proteins produced from appropriate vectors. Sufficient ... to 1 mg target protein under native ... with S-protein Agarose, which specifically retains STag ...
Request Info...
... Epitope: aa 16-25 of human GSK3 alpha. ... Store vial at -20 C prior to opening. ... contents and freeze at -20 C or below. Avoid ... Other Sub-Family: not assigned-Other ...
Biology Products: