FIRALIS : co-Authors SAFE-T review paper

July 2011 - FIRALIS co-authors a foundation review paper :
Qualification of Drug Induced Organ Injury Biomarkers -

Firalis SAS, with several of its members, co-authored a paper outlining a generic qualification strategy for drug induced organ injury biomarkers. The paper was published in the peer reviewed journal Drug Discovery Today (Vol. 16 No 13&14/24) “A generic operational strategy to qualify translational safety biomarkers”. These safety biomarkers are intended to accelerate drug development by providing to the pharmaceutical industry tools to assess the effect of drug candidates on the liver, the kidneys and the vasculature. This strategy, established by the team of experts collaborating within the SAFET consortium, outlines a method to generate sufficient preclinical and clinical evidence for the qualification of translational safety biomarkers.

The SAFE-T consortium is a large public/private consortium funded by the European Commission Innovative Medicines Initiative (IMI). Firalis, the initiator of the public consortium, is playing a central role in this project by participating in the design of the scientific strategy, the execution of clinical studies, the development of biomarker assays and the analysis of biomarker data.

“Firalis’ position among this team of international experts testifies its expertise in biomarker qualification and highlights its place as a leading actor in this highly competitive and dynamic field.” commented Dr. Béatrice Molac, director of regulatory affairs at Firalis.

With this publication, the SAFE-T consortium targets a larger scientific community and expects to trigger a valuable exchange with key opinion leaders and other stakeholders on the proposed strategy...

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...About FIRALIS SAS

Firalis is a privately owned life sciences biotechnology company, creating novel values via biomarker discovery, development and regulatory qualification; to establish an internal portfolio of biomarker-based diagnostic methods and provide customer-tailored biomarker solutions. Firalis is active in the field of cardiovascular, inflammatory and autoimmune diseases... FIRALIS' Press Release -

BioAlliance Pharma : Grant of « orphan designation » for clonidine Lauriad™ in Europe

November 02, 2011 - BioAlliance Pharma SA (Euronext Paris - BIO) , a company dedicated to specialty and orphan oncology products, announced that clonidine Lauriad™ has been granted orphan designation by the European Commission in the prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer.

Oral mucositis is a very frequent inflammation of the oral mucosa in head and neck cancer patients treated with radio- and chemotherapy (98,000 new patients estimated per year in Europe). Severe oral mucositis occurs in 60% of these patients and may induce intense oral pain and eating disability requiring artificial nutritional support. In 20 to 30% of cases, patients have to be hospitalized and the disease may result in a modification or a stop of the radiotherapy treatment in more than 10% of them. Radiotherapy-induced oral mucositis has currently no preventive cure.

In Europe, the orphan designation is granted for medicinal products in diseases affecting less than 5/10,000 patients. This status permits to benefit from incentives related to the clinical development, thus enabling a faster registration, and an extra protection with a 10- year commercial exclusivity after market authorization... 

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...About BioAlliance Pharma

Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products –– BioAlliance conceives and develops innovative products, for specialty markets especially in the hospital setting and for orphan or rare diseases.

Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma’s ambition is to become a leading player in these fields by coupling innovation to patient needs. The company’s teams have the key competencies required to identify, develop and register drugs in Europe and the USA; the products’ commercialization rights are licensed to international commercial partners invested in the hospital setting. In areas where medical needs are insufficiently met, its targeted approaches help overcome drug resistance and improve patient health & quality of life... BioAlliance Pharma's Press Releases - Communiqués de Presse de BioAlliance Pharma -

Genticel has completed recruitment of patients for its Phase I trial with ProCervix

Toulouse, France, October 19th 2011 - Genticel has completed recruitment of patients for its Phase I trial with ProCervix, its therapeutic vaccine against human papillomavirus (HPV) types 16 and 18 -

Genticel announces that it has completed the recruitment of all patients participating in its phase one clinical trial with a liquid formulation of ProCervix, its candidate therapeutic HPV vaccine designed for adult women already infected with human papillomavirus (HPV) genotype 16 or 18.

The trial takes place at the Centre for the Evaluation of Vaccinations in the Vaccine & Infectious Disease Institute of the University of Antwerp, under the direction of professor Pierre Van Damme. The key objectives are to evaluate the safety and immunogenicity of ProCervix.

In addition, Belgium’s Federal Agency for Medicines and Health Products (FAMHP) has recently also approved Genticel’s request to extend the phase I trial to confirm the safety of a lyophilized formulation of ProCervix.

“We are delighted with the advancement of this important phase I trial that should provide valuable information with regards to safety, local tolerance and immunogenicity,” said Dr Benedikt Timmerman, CEO of Genticel. “Now we have approval for the evaluation of our new lyophilized formulation, Genticel expects to have completed its full Phase I Program in the first half of 2012 and move on to Phase II before the end of the year.”

About ProCervix

This investigational vaccine, called ProCervix, uses the Adenylate Cyclase (CyaA), a protein vector delivering the E7 antigens from HPV16 and HPV18. The CyaA vector directly targets professional antigen presenting cells (APC). Through its unique delivery mode, CyaA allows the antigen to induce strong CD4+ and CD8+ T cell responses. ProCervix is the first HPV vaccine to leverage the CyaA’s mode of action... [PDF] Genticel's Press Release -