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BioAlliance Pharma Announces Preliminary Phase III Data On Miconazole Lauriad Bioadhesive Buccal Tablets For Local Treatment of Oropharyngeal Candidiasis in Head and Neck Cancer Patients Following Radiation Therapy

Posted on: Tuesday, 4 January 2005, 06:00 CST

Results Complement Phase III Data In HIV Patients - Company to File for Registration in Europe and Submit IND for Phase III in U.S.

BioAlliance Pharma, a biopharmaceutical company focused on the field of drug resistance, today announced significant positive results from its confirmatory Phase III pivotal study of the miconazole Lauriad(R) 50mg Bioadhesive Buccal Tablet. The results concerned the treatment of oropharyngeal candidiasis in head and neck cancer patients following radiotherapy. The study demonstrates the potential efficacy and safety of a new formulation of miconazole administered as a bioadhesive extended release buccal tablet. The tablet contained 10 times less active drug compared to the same drug applied in a topical gel for treatment of oropharyngeal candidiasis, an oral fungus commonly found in immuno-compromised patients, including HIV and cancer patients, diabetics and the elderly.

With the EU clinical program now completed, the results of this investigation together with a previously completed supportive Phase III study in HIV-positive patients will form the basis of a registration filing in the EU in early 2005. An IND to conduct a pivotal Phase III trial in HIV-positive patients with oropharyngeal candidiasis is on track for filing with the U.S. FDA, also in early 2005.

"The results from these studies are strongly indicative of the efficacy and safety of our once a day topical formulation of the miconazole extended release, bioadhesive buccal tablet for first line local treatment of oropharyngeal candidiasis," said Dominique Costantini, M.D., president and CEO of BioAlliance Pharma. "These excellent results for one of BioAlliance's key technologies are extremely encouraging in terms of the company's future development."

Phase III Study in Head & Neck Cancer Patients

The trial was a comparative, noninferiority study, including a blind evaluation of clinical results, conducted at 36 sites in Europe and North Africa. This study was an open-label, multi-center, randomized, and controlled Phase III study in 308 patients with head and neck cancer being treated by irradiation. The primary objective of the study was to evaluate the clinical efficacy of miconazole Lauriad(R) tablets on oropharyngeal candidiasis after 14 consecutive days of treatment.

In this study, miconazole Lauriad tablets were compared with miconazole gel, which is marketed in Europe for the treatment of oropharyngeal candidiasis. Miconazole gel was administered in the oral cavity (125 mg/4 times per day) for 14 days. Enrollment was completed in April 2004. Further analyses of the data are ongoing and will be submitted for presentation at an upcoming international scientific conference.

Phase III Study in HIV-Positive Patients

The company has previously reported results from a multi-center, open-label, non-comparative Phase III trial completed in August 2003 and designed to evaluate the efficacy and safety of the 50 mg miconazole Lauriad(R) bioadhesive buccal tablet in HIV-positive patients suffering from oropharyngeal candidiasis (13th International Symposium on HIV & Emerging Infectious Diseases, Toulon, France, June 2004; Annual Congress of the French Society of Medical Mycology, Montpellier, France, June 2004).

This study was originally planned to include 60 patients but was stopped under the protocol after reaching 25 patients, following a group-sequential response-adaptive design based on a success rate of 70%. The results showed 94.7% clinical efficacy following 14 days of treatment.

In the study of HIV-positive patients, oropharyngeal candidiasis was clinically documented and confirmed by fungal culture before inclusion. Patients were treated for 14 days and those who exhibited a clinical response were followed up to an additional month to evaluate the relapse rate. Primary efficacy was defined by a complete disappearance of oral lesions or decrease of more than 50% of lesion extension after 14 days of treatment (clinical response).

Miconazole Lauriad(R) showed a 94.7% clinical response (18 of 19 patients PP) after 14 days of treatment, with fungal eradication (negative fungal culture) seen in 31.6% of patients (6 of 19). The absence of plasma concentration of miconazole at day 7 of treatment demonstrates that miconazole Lauriad(R) acts only locally.

"The results of this study confirm the efficacy and safety of the miconazole Lauriad(R) 50 mg bioadhesive buccal tablet to treat oropharyngeal candidiasis in patients with a severe immuno-compromised status," said Prof. Bertrand Dupont, Head of Infectious and Tropical Diseases, Necker Hospital, Paris, France, and coordinator of the HIV study. "This new formulation of miconazole may represent an effective therapeutic alternative to other topical products or systemic treatments and could improve patient compliance."

About BioAlliance Pharma

BioAlliance Pharma is a privately held late stage biopharmaceutical company focused on drug resistance through development and commercialization of innovative therapeutics targeting markets in cancer, HIV, severe infections and supportive care. The company has two broad proprietary drug delivery platforms represented by the Lauriad(R) adhesive technology and the Transdrug(R) nanoparticle technology that provide multiple product opportunities. Together with a New Chemical Entities program focused on development of new drugs in oncology and HIV, the company is able to address worldwide markets in the EU, US, and Asia.

The company's lead product within its adhesive technology program, the miconazole Lauriad(R) 50 mg Bioadhesive Buccal Tablet, is being investigated in two recently completed Phase III trials in Europe for treatment of oropharyngeal candidiasis in cancer and HIV patients. A Phase I/II trial in hepatocellular carcinoma utilizing the company's doxorubicin Transdrug(R) nanoparticle delivery technology is ongoing in Europe, where it has been granted an orphan medicinal product designation by the EMEA. For additional company background, please visit the BioAlliance Pharma web sites at: www.BioAlliancepharma.com and www.viralliance.com.

Source: Business Wire

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