Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Adocia Announces its Phase III Development Program for the Treatment of DFU

Published: Wednesday, March 20, 2013
Last Updated: Wednesday, March 20, 2013
Bookmark and Share
This program has been validated by scientific advice from the European Medicines Agency.

Adocia has announced the phase III development program of its product, BioChaperone® PDGF-BB for the treatment of diabetic foot ulcer (DFU). The European Medicines Agency (EMA) issued positive scientific advice for this program.

Adocia has developed a unique formulation, a BioChaperone PDGF spray for the treatment of DFU. Based on the positive results of the phase II clinical trial in India, Adocia has filed a dossier for a phase III clinical trial there.

This dossier is currently under review by the DCGI (Drugs Controller General of India). The trial should permit Adocia to file a request for marketing authorization in India and other emerging countries.

Adocia is also actively preparing a clinical program for marketing the product in Europe and the United States of America.

In Europe, Adocia is focusing on the treatment of neuroischemic DFU which is the most frequent form of the disease; affecting 60 per cent of patients. It is the most difficult to heal with a high rate of amputation.

There is currently no approved treatment for neuroischemic DFU. There is a medical need for this indication which should facilitate the regulatory approval of a treatment for the disease.

In order to validate the regulatory pathway for the Marketing Authorization Application (MAA) Adocia has asked for scientific advice from the EMA.

The EMA agrees that only one phase III study conducted in Europe would be required for the MAA. In addition, the clinical data from the phase III trial in India would be admissible to the MAA.

The EMA advice also included agreement on the design and protocol features of the Phase III trial. The pivotal phase III clinical trial in Europe is designed to assess the efficacy of BioChaperone PDGF-BB compared to a placebo for the treatment of neuroischemic DFU. The trial is expected to be launched in mid 2014.

“This scientific advice from the EMA which validates our clinical program in Europe is an important milestone. We are now preparing the submission of the clinical development plan for the FDA in the USA,” said Olivier Soula, director of R&D and deputy general manager, Adocia.

“This positive advice was critical in order to move forward in our discussions with potential partners as it helps to define budget and milestones until commercialization,” said Gerard Soula, president & CEO of Adocia.

Next scheduled events
• March 20, 2013 - Publication of 2012 financial statements.
• March 21, 2013 - Presentation meeting to investors, SFAF, at Euronext (Paris)

Adocia will attend Future Leaders in Biotech in New York (USA) on April 5, 2013.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More Than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Adocia Reports Positive Results from Phase IIa Clinical Study of BioChaperone® Lispro
The ultra-fast action of BioChaperone Lispro should make a positive impact on short and long-term glycemic control, improving the medical benefit for patients.
Friday, April 11, 2014
Adocia Confirms Positive Clinical Results for its BioChaperone® Combo
BioChaperone Combo is the first combination based on insulin glargine to show a fast and long action in type I diabetic patients.
Friday, March 21, 2014
Adocia Strengthens its Diabetic Foot Ulcer Patent Portfolio
The patent on the BioChaperone® polymer used in the PDGF composition recently granted in the United States.
Thursday, January 16, 2014
Adocia Launches Phase IIa Clinical Trial for its Ultra-fast Acting Formulation of Analog Insulin
The aim is to confirm on type I diabetic patients the positive results obtained during phase I.
Tuesday, January 07, 2014
Adocia Signs an Exclusive License on a Nanotechnology
Preclinical results have already demonstrated its remarkable action on solid tumors.
Monday, December 09, 2013
Adocia Announces Initiation of a Clinical Trial on its Combination of Glargine and Lispro
This phase I/II clinical trial on Type I diabetics seeks to compare the performance of this Combo based on insulin Glargine with HumalogMix®.
Monday, November 18, 2013
Adocia Announces Revenues of EUR 4.7 M for the Third Quarter of 2013
The company maintained available cash at EUR 22.7 M.
Thursday, October 24, 2013
Adocia Reacquires Exclusive Development Rights to Ultra-Fast Acting Insulin Analog
Adocia and Lilly terminate collaboration.
Tuesday, July 30, 2013
Adocia Announces a Strengthened Intellectual Property on its Lead Project for its Chronic Wounds Treatment
USPTO and EPO have issued a patent to Adocia covering BioChaperone PDGF formulations for chronic wound treatment.
Thursday, June 14, 2012
Adocia Reports Positive Phase II Clinical Results for the Treatment of Diabetic Foot Ulcer
Adocia’s spray formulation of PDGF-BB, combined with BioChaperone®, has been evaluated versus Regranex®, gel of PDGF-BB.
Tuesday, April 24, 2012
Adocia Reports Positive Phase I Clinical Results on HinsBet®, a Fast-Acting Human Insulin
Study on healthy volunteers of a formulation using Adocia’s BioChaperone® platform showed fast onset of action, excellent local tolerance, absence of pain and low inter-patient variability.
Wednesday, March 16, 2011
Scientific News
NIH Study Finds Calorie Restriction Lowers Some Risk Factors for Age-Related Diseases
Two-year trial did not produce expected metabolic changes, but influenced other life span markers.
Immunotherapy Agent Benefits Patients with Drug-Resistant Multiple Myeloma in First Human Trial
Daratumumab proved generally safe in patients, even at the highest doses.
Low-level Arsenic Exposure Before Birth Associated with Early Puberty in Female Mice
Study examine whether low-dose arsenic exposure could have similar health outcomes in humans.
Inciting an Immune Attack On Cancer Cells
A new minimally invasive vaccine that combines cancer cells and immune-enhancing factors could be used clinically to launch a destructive attack on tumors.
‘Mutation-Tracking’ Blood Test for Breast Cancer
Scientists have developed a blood test for breast cancer able to identify which patients will suffer a relapse after treatment, months before tumours are visible on hospital scans.
Cellular Contamination Pathway for Heavy Elements Identified
Berkeley Lab scientists find that an iron-binding protein can transport actinides into cells.
Intensity of Desert Storms May Affect Ocean Phytoplankton
MIT study finds phytoplankton are extremely sensitive to changing levels of desert dust.
Common ‘Heart Attack’ Blood Test May Predict Future Hypertension
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressure.
LaVision BioTec Reports on the Neuro Research on the Human Brain After Trauma
Company reports on the work of Dr Ali Ertürk from the Institute for Stroke and Dementia Research at LMU Munich.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!