BioAlliance Pharma: Files IND for US Pivotal Phase III Trial.PARIS Paris, in Greek mythology Paris or Alexander, in Greek mythology, son of Priam and Hecuba and brother of Hector. Because it was prophesied that he would cause the destruction of Troy, Paris was abandoned on Mt. -- BioAlliance Pharma Files IND for US Pivotal Phase III Trial of Miconazole miconazole /mi·con·a·zole/ (mi-kon´ah-zol) an imidazoleantifungal agent used as the base or the nitrate salt against tinea and cutaneous or vulvovaginal candidiasis. Lauriad(R) for Treatment of Oropharyngeal oropharyngeal /oro·pha·ryn·ge·al/ (-fah-rin´je-al) 1. pertaining to the mouth and pharynx. 2. pertaining to the oropharynx. Candidiasis BioAlliance Pharma, a biopharmaceutical company focused on the field of drug resistance, announced today that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to conduct a pivotal Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of its antifungal agent, miconazole Lauriad(R). This is a once-daily 50 mg extended-release Bioadhesive Buccal Tablet being investigated as a first-line local treatment for oropharyngeal candidiasis (OPC), an oral fungus. OPC infections are frequent within immunocompromised populations, such as those represented by cancer therapy, HIV-infection, ICU ICU intensive care unit. ICU abbr. intensive care unit ICU see intensive care unit. ICU and transplant patients, diabetes mellitus, and denture denture, artificial replacement for natural teeth and surrounding tissue. Dentures are classified as partial or complete. The former are removable and maintained by clasps, or are fixed bridges with crowns cemented over adjacent teeth or over spikes embedded in the use. Pending clearance by the FDA, BioAlliance intends to initiate the Phase III trial in the fourth quarter of 2005. "The miconazole Lauriad IND filing represents the accomplishment of one of our key objectives for 2005, and we are looking forward to advancing this product through the clinic as we have already done in the EU," said Dominique Costantini, M.D., president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of BioAlliance Pharma. "The rationale for development of an extended-release bioadhesive buccal tablet is to reach a constant antifungal salivary concentration, increase contact time with effective drug concentrations and reduce the risk of resistance while providing for once-daily administration to improve patient compliance." The pivotal Phase III trial in HIV-positive patients will be conducted under the Section 505(b)(2) approval mechanism, allowing for a single Phase III trial based on previous approval of a drug product (miconazole) through reliance upon the FDA's prior findings of safety and efficacy together with third party data on safety and effectiveness available in the published literature. As part of the IND filing, BioAlliance will also submit the results of two completed Phase III trials conducted in the EU, one in head & neck cancer patients following radiotherapy and the other in HIV-positive patients. 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 HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , severe infections and supportive care. The company has two broad proprietary drug delivery systems 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. EU registration is on track for filing in Q3 2005 and a pivotal Phase III trial in the same indication is planned to start in the U.S. later this year. A near term follow-on product, acyclovir Lauriad(R) for treatment of oral herpes, using the same delivery system, entered a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I in April in the EU. A Phase I/II trial in hepatocellular carcinoma utilizing the company's doxorubicin Transdrug(R) nanoparticle delivery technology is ongoing in Europe, and has been granted orphan drug status by the EMEA and the US FDA. For additional company background, please visit the BioAlliance Pharma web sites at: www.BioAlliancepharma.com and www.viralliance.com. |
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