BioAlliance Announces Positive Preliminary Results in the First Phase I Clinical Trial of fentanyl Lauriad
Sustained systemic absorption means that administration for severe chronic cancer pain can be envisaged
PARIS--(BUSINESS WIRE)--Mar 10, 2010 - Regulatory News:
BioAlliance Pharma SA (Paris:BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced positive preliminary results from the first Phase I trial of fentanyl Lauriad®.
This first randomized, single-centre trial in healthy volunteers has evaluated the pharmacokinetics of a single application of 2 different innovative muco-adhesive formulations of fentanyl Lauriad®. The fentanyl was detected in the plasma soon after the application of each formulation and plasma concentrations remained stable over the next 24 hours, with low intersubject variability, especially for one of the two formulations that will be used for subsequent clinical development. Both muco-adhesive buccal formulations displayed a good local safety profile. These preliminary results suggest that a single daily application of fentanyl Lauriad® may provide effective relief of severe chronic pain in cancer patients. The company is planning to perform a second pharmacokinetic repeated-dose study by the end of the year.
“The success of this first Phase I clinical trial with fentanyl Lauriad® relies on our original know-how in mucosal drug delivery”, explained Dominique Costantini, BioAlliance Pharma's President and CEO. “The Lauriad® technology has been extended to fentanyl and enables molecules which can cross the mucosa to remain in the body for long periods. This is a very important step on the path to clinical development for fentanyl Lauriad®”.
About this first Phase I trial of fentanyl Lauriad®
This clinical trial was performed in healthy volunteers who were successively administered two innovative formulations one week apart according to a randomized design. The objective was to obtain stable fentanyl plasma concentrations over several hours. Fentanyl has already been shown to be systemically absorbed through the mucosal route leading to the development of fentanyl-based treatments for severe, acute pain. With the patented Lauriad® formulation, fentanyl is rapidly and continuously released in the oral mucosa and systemically absorbed. This concept of a sustained release addresses the treatment of cancer chronic pain.
About BioAlliance Pharma
As a preferred partner for hospital-based specialists, BioAlliance Pharma is a company which develops and markets innovative products in France, especially in the fields of opportunistic infections and chemotherapy complications. In areas where medical needs are insufficiently met, our targeted approaches help overcome drug resistance and improve patient health & quality of life. BioAlliance Pharma's ambition is to become a leading player in these fields by coupling innovation to patient needs.
For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com.
This communication expressly or implicitly contains certain forward-looking statements concerning BioAlliance Pharma SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioAlliance Pharma SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioAlliance Pharma SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the 2008 Reference Document filed with the AMF on April 7, 2009, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).
Contact: BioAlliance Pharma SA
Dominique Costantini, President and CEO
Tel.: +33 1 45 58 76 01
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 00
Tel.: +33 6 64 18 99 59 / email@example.com
Posted: March 2010