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BioAlliance Pharma announces the forthcoming extension of its phase II clinical trial with Validive® in the United States
BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, announces the extension of its phase II clinical trial with Validive® (clonidine Lauriad™) in the United States in radio/chemotherapy-induced oral mucositis prevention in patients with head and neck cancer.
Further to approval by the United States FDA (Food and Drug Administration), BioAlliance Pharma will extend its clinical trial to the United States, increasing the number of clinical investigation centers involved in this randomized double blind phase II trial.
So far almost 50% of planned patients have been enrolled in about 30 European centers. With the upcoming initiation of several centers in the United States, BioAlliance Pharma expects to finalize trial recruitment in early 2014 with results expected the same year.
“Beyond accelerating recruitment, the extension of the trial to the United States is also a key factor to reinforce our international panel of scientific experts and clinical investigators around Validive®. This will raise awareness and create hands-on experience of the drug of future key prescribers of Validive® in major US centers specialized in oncology and radiotherapy,” stated Judith Greciet, CEO of BioAlliance Pharma.
Severe oral mucositis is a particularly invalidating pathology occurring in more than 60% of patients treated with radio/chemotherapy for head and neck cancer and has currently no validated curative or preventive treatment. It may induce intense oral pain and eating disability requiring enteral or parenteral nutritional support. Thirty per cent of patients need to be hospitalized as a result and symptoms can force patients to stop treatment for an undefined period thus reducing treatment efficacy.
Clonidine is a sympatholytic medication used to treat medical conditions, such as high blood pressure, ADHD, anxiety/panic disorder, and certain pain conditions. It is classified as a centrally acting α2 adrenergic agonist. An alternative hypothesis that has been proposed is that clonidine acts centrally as an imidazoline receptor agonist.
Clonidine, 2-(2,6-dichlorophenylamino)imidazoline, is synthesized from 2,6-dichloroaniline, the reaction of which with ammonium thiocyanate gives N-(2,6- dichlorophenyl)thiourea. Methylation of this product, followed by the subsequent reaction with ethylene diamine gives clonidine.
- K. Zeile, H. Staehle, K. H. Hauotman, DE 1303141 (1961).
- H. Stahle, K. Zeile, U.S. Patent 3,202,660 (1965).
- K. Zeile, K. H. Hauotman, H. Stahle, U.S. Patent 3,236,857 (1966).
- Boehringer Sohn Ingelheim, BE 653933 (1964).
- Boehringer Sohn Ingelheim, GB 1016514 (1962).
- Boehringer Ingelheim GmbH, GB 1034938 (1964).
US patent 3937717, Stahle, H.; Koppe, H.; Kummer, W.; Stockhaus, K., “2-Phenylamino-imidazolines-(2)”, issued 1976-02-10, assigned to Boehringer Ingelheim GmbH
CLORPRES (clonidine hydrochloride and chlorthalidone) ® is a combination of clonidine hydrochloride (a centrally acting antihypertensive agent) and chlorthalidone (a diuretic).
CLORPRES (clonidine hydrochloride and chlorthalidone) ® is available as tablets for oral administration in three dosage strengths: 0.1 mg/15 mg, 0.2 mg/15 mg and 0.3 mg/15 mg of clonidine hydrochloride/chlorthalidone, respectively.
The inactive ingredients are ammonium chloride, colloidal silicon dioxide, croscarmellose sodium (Type A), magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, D&C yellow #10.
Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-[(2,6-dichlorophenyl)imino]imidazoline monohydrochloride. The following are the structural formula, molecular formula and molecular weight:
Clonidine hydrochloride is an odorless, bitter, white crystalline substance soluble in water and alcohol.
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.