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BioAlliance Pharma SA (Paris:BIO), the specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV, announced today the suspension of its Phase II trial of doxorubicin Transdrug® in primary liver cancer. The company is following advice (as set out in the study schedule) provided by the Drug Safety Monitoring Board and the Steering Committee, which have been continuously monitoring the trial's progress. On the basis of the initial data, the two committees observed a clinical benefit but also more frequent and more severe pulmonary adverse events than expected and have thus recommended suspension of the trial, given the incidence of this type of effect.
This type of acute pulmonary damage was observed in Phase I/II trial at a dose of 35mg/m2 (the maximum tolerated dose) but had not been observed at 30mg/m2, the dose chosen for repeated administrations in the next development phase.
In this Phase II trial, doxorubicin Transdrug® was being compared with the current standard of care (a control group undergoing Trans-Arterial Chemo-Embolization).
In terms of the criteria for assessing the efficacy and safety of repeated intra-arterial hepatic injection of doxorubicin Transdrug®, the efficacy endpoint was based on progression-free survival after 3 months of treatment.
"Non-operable primary liver cancer in cirrhotic patients has a very poor prognosis. There are few effective treatments, and it is therefore important to evaluate the benefit/risk ratio of therapeutic innovations," stated Dominique Costantini, BioAlliance Pharma's co-founder, President and CEO. "We scheduled Drug Safety Monitoring Board and Steering Committee meetings into the trial's timeline and we have been following their recommendations".
Our product portfolio is based on independent innovations, and each has its own risks. This allows us to redirect our focus so if this trial has to be suspended permanently, we shall bring another compound into the clinical phase," added Dominique Costantini.
About BioAlliance Pharma SA
BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The company develops and commercializes innovative products which address resistance issues. The company has launched its first portfolio product (Loramyc®) in France and already received European Marketing Authorizations in UK, Germany, Belgium, Denmark and Luxemburg. The compound has completed the pivotal Phase III clinical development in oropharyngeal candidiasis in the USA. In addition, two other innovative products are currently in Phase III clinical trials: acyclovir Lauriad® in oral herpes (based on the same Lauriad® muco-adhesive technology as Loramyc®, which enables targeted release at the disease site) and doxorubicin Transdrug® in primary liver cancer (based on the Transdrug® nanoparticle technology, designed specifically for intracellular targeting of resistant cells). The company is also developing a new therapeutic entities program focused on the oncology and infectious disease markets.
In 2007, the company has established strategic alliances for commercializing Loramyc® in Europe (with JV SpeBio) and in the USA with Par Pharmaceutical. In March 2008, BioAlliance Pharma signed a partnership agreement with Handok Pharmaceuticals for commercializing Loramyc® in Korea, Taiwan, Singapore and Malaysia and with Novamed Pharmaceuticals in June 2008 for commercialization of Loramyc™ in China. In May 2008, the company expanded its product portfolio via acquisition of the European commercial rights to ondansetron Oral Spray (OS) from NovaDel Pharma Inc. (Amex: NVD).
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 reference document approved by the AMF on April 11 2008 under the number R. 08-021, which is available on the AMF website (www.amf-france.org) or on BioAlliance Pharma S.A.'s website (www.bioalliancepharma.com).
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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
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