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Drug Clinical Trials

N30 Pharma Initiates Human Studies With N30-201

N30 Pharma has successfully completed Phase 1 study of N30-201 in healthy volunteers. N30 intends to develop N30-201 for the treatment of reactive and obstructive airway diseases, including Cystic Fibrosis and asthma.

"We are pleased to have begun and completed the first set of human studies of N30-201. We believe that N30-201 could be an important therapy for the treatment of many respiratory diseases. Determining the safety of acute administration of N30-201 to human subjects is the first step," commented Charles Scoggin, M.D., Chairman of N30 Pharma.

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Takeda Initiates Study Of Hematide

Takeda Pharmaceutical has dosed the first patient in US in a clinical trial of the investigational new drug, Hematide, for the treatment of anemia in cancer patients undergoing chemotherapy.

Under the terms of the 2006 collaboration, Takeda and Affymax are jointly developing Hematide, and Affymax is now conducting Phase 3 studies for the treatment of anemia in chronic renal failure patients in the U.S. and Europe.

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Derma Sciences To Enter Phase II Development Of Wound Healing Product

Derma Sciences, San Luis Obispo-based to enter Phase II clinical development of DSC127, a novel and rapid wound-healing and scar-reduction product that has a unique mechanism of action potentially linked to the body's own, naturally occurring stem cells.

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Clinical Trial Shows Progression Free Survival In Patients With Non-Follicular Indolent

Cell Therapeutics announced results of a phase II clinical study: the addition of radioimmunotherapy to chemotherapy for previously untreated patients with non-follicular indolent non-Hodgkin's lymphoma was both well tolerated and effective.

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CeloNova's Positive Results From Study Of Embozene Microspheres For Treatment Of Uterine Fibroids

CeloNova BioSciences has released data from THE SPHERE, an 11 center, 8 country European study of uterine fibroid embolization using the Company's Embozene Microspheres. The study results were reported at the 20th Annual International Symposium on Endovascular Therapy.

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ProMetic, MacoPharma Successfully Complete P-Capt Clinical Studies

The successful completion of two human clinical studies performed on volunteers using the P-Capt prion reduction filter for red cell concentrates has been announced by ProMetic, MacoPharma. The clinical studies evaluated the effect of the filter on units of red cell concentrate collected from human volunteers, to ensure that the use of the filter had no negative effect on the red blood cells themselves. Data demonstrated no negative impact.

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Genaera Initiates Trial Of Type 2 Diabetes, Obesity Compound Trodusquemine

Study 103 is similar in design to the previously completed Study 101 which was conducted in healthy obese and overweight volunteers. The current study will continue to expand the safety database for MSI-1436 and establish the pharmacokinetics of the drug in a population of type 2 diabetics who are poorly controlled on metformin. The study will also evaluate a range of secondary endpoints including short-term insulin/glucose control indices, glucose tolerance and evaluation of insulin sensitivity.

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Zevalin, Chemotherapy, ASCT Combination Produces High Overall Survival In Patients With Relapsed Non-Hodgkin's Lymphoma

Results of Cell Therapeutics' phase II clinical study demonstrate that the addition of radioimmunotherapy to high-dose chemotherapy followed by autologous stem-cell transplantation produced a high rate of progression-free survival.

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Cogentus's Clinical Study To Confirm Full Antiplatelet Benefit Of New Combination Medicine

Cogentus Pharmaceuticals has begun dosing in a clinical study to confirm the full antiplatelet activity of its novel combination medicine CGT-2168. CGT-2168 is a once-daily capsule that combines clopidogrel (currently marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis as Plavix) with a gastroprotectant (omeprazole) to improve the gastrointestinal safety of antiplatelet therapy.

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MAP Reaches Agreement With FDA On MAP0004 Clinical Trial In Patients With Migraine

MAP Pharmaceuticals has completed the special protocol assessment process with FDA for the first Phase 3 clinical trial of its MAP0004 product candidate, and has reached agreement with the Agency on the design of the protocol.

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CeNeRx BioPharma Successfully Completes Clinical Program For Novel Antidepressant Agent Tyrima

CeNeRx BioPharma announced successful completion of the Phase l clinical program for Tyrima, its lead candidate for the treatment of depression and anxiety. Tyrima is a selective and reversible member of a novel class of drugs known as RIMAs, or reversible inhibitors of monoamine oxidase A. The Phase l program included acute dose, repeat dose and fed-fasted studies. The results of all studies were favorable, showing that Tyrima was safe and well tolerated and exhibited good pharmacokinetic properties.

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Anthera Announces Positive Results From Cardiovascular Trial

Anthera Pharmaceuticals reported preliminary results of a second Phase IIb clinical trial of A-002, for the treatment of cardiovascular disease. In this second study, administration of once-daily A-002 lowered both sPLA2 and LDL-C levels confirming the positive effects of A-002 treatment seen in the twice-daily PLASMA study (Phospholipase Levels And Serological Markers of Atherosclerosis) announced in October 2007.

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