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Clinical Trials Update provides you with latest news about clinical trials conducted by MVA member companies. The update gives insight to progress in studies, results and possible indications. As an MVA member please feel free to send us press releases for Clinical Trials Update at akn@mva.org.
Week 27
Headline Results of Flurizan® in Clinical Phase III Trial
30 June - Myriad Genetics, Inc. has today announced the outcome of a clinical phase III trial of Flurizan® (tarenflurbil) in 1,684 patients with mild Alzheimer's disease. The clinical phase III data do not correspond to the data observed in clinical phase II in patients with mild Alzheimer's disease. Lundbeck and Myriad will now investigate the data further to understand the outcome of the trial in which the compound did not meet the two primary endpoints.
Week 26
Genmab Initiates Study Of Zalutumumab With Radiotherapy in Head and Neck Cancer
24 June - Genmab A/S has announced that it has initiated a Phase I/II study of zalutumumab in combination with radiotherapy for the treatment of advanced head and neck cancer. The study will include a maximum of 36 patients who are ineligible for platinum based chemotherapy.
RhuDex Achieves Positive Results in Clinical Phase IIa Trial
24 June - Active Biotech's collaboration partner MediGene AG has achieved its objectives in a clinical phase IIa trial of the candidate drug RhuDex for the treatment of rheumatoid arthritis.
In addition to positive safety data and the good adsorption after oral administration, a first indication of biological activity of RhuDex was observed.
Week 25
Active Biotech's Novel MS Compound laquinimod Featured in The Lancet
21 June - The scientific journal The Lancet, Volume 371, Issue 9630, includes an article covering Active Biotech's and Teva Pharmaceutical Industries Ltd's novel oral MS drug laquinimod. The article, entitled "Effect of Laquinimod on MRI-monitored disease activity in patients with RRMS: a multicenter, randomized, double-blind, placebo-controlled phase IIb study", will be available on www.thelancet.com. Laquinimod is currently in global clinical Phase III trials.
NeuroSearch Announces Positive Key Results from Phase II Study with ABT-894 in Adults with ADHD
20 June - NeuroSearch reports positive results from a Phase II study with ABT-894, a neuronal nicotinic receptor (NNR) modulator, for the treatment of adults suffering from Attention-Deficit Hyperactivity Disorder (ADHD). Results from the Phase II study show that ABT-894 was efficacious in adult ADHD measured as a statistically significant improvement on the primary endpoint; the total score of the Conners' Adult ADHD Rating Scales (CAARS).
Bavarian Nordic Reports Interim Data From Phase I/II Studies With Breast Cancer Vaccine
19 June - Bavarian Nordic's cancer research unit, BN ImmunoTherapeutics, has completed an interim analysis of its first two clinical studies with MVA-BN(R)-HER2, a cancer vaccine immunotherapy for breast cancer patients. These preliminary data show that MVA-BN(R)-based, HER2 directed vaccination is a biologically active treatment for patients with HER2 positive breast cancer. The final study data are expected around the turn of the year 2008/2009.
TopoTarget has Received Detailed Advice from the FDA Concerning its Pivotal Trial with Belinostat in PTCL
19 June - TopoTarget announces that FDA during a Special Clinical Protocol Assessment has reviewed TopoTarget's Periferal T-Cell Lymphoma protocol suggestions and has provided suggestions for protocol changes especially with respect to assure uniform criteria in the pathology classification of the diagnosis of PTCL. TopoTarget expects to start the pivotal study in PTCL in 2nd half of 2008.
ACADIA Pharmaceuticals Announces Results from ACP-104 Phase IIb Schizophrenia Trial
16 June - ACADIA Pharmaceuticals have announced results from its Phase IIb trial with ACP-104 for the treatment of schizophrenia. The study did not meet its primary endpoint of antipsychotic efficacy or any of the secondary endpoints. Neither dose of ACP-104 demonstrated improved efficacy as compared to placebo.
Week 24
Novo Nordisk discontinues phase 3 clinical trial with NovoSeven in trauma
11 June - Novo Nordisk today announced the decision to discontinue the phase 3 clinical trial with NovoSeven for the treatment of bleeding in patients with severe trauma. The decision was made based on the results of an analysis for futility conducted by the independent Data Monitoring Committee.
Ofatumumab in subcutaneous study in rheumatoid arthritis
10 June - Genmab has announced that the will initiate a Phase I/II study to evaluate a subcutaneous route of administration of ofatumumab (HuMax-CD20) in rheumatoid arthritis patients, stable on methotrexate. Ofatumumab is an investigational drug being developed to treat chronic lymphocytic leukemia, follicular non-Hodgkin's lymphoma, diffuse large B-cell lymphoma and rheumatoid arthritis under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
Over 70% of patients reach target with NovoMix® 30 in largest ever diabetes study
9 June - New data from the IMPROVE study show that significant improvements in glycaemic (blood sugar) control can be achieved with premixed modern insulin, NovoMix 30, in patients poorly controlled on other, or no previous pharmaceutical treatment. The results were announced over the weekend at the 68th annual meeting of the American Diabetes Association in San Francisco.
Clinical study shows liraglutide reduced blood sugar, weight and blood pressure in patients with type 2 diabetes
9 June - Phase 3 data highlight sustained efficacy and benefits of early treatment with liraglutide versus glimepiride. Data presented over the weekend at the 68th Scientific Sessions of the American Diabetes Association demonstrated that once-daily liraglutide when taken alone produced statistically significant improvement in blood sugar (glucose) control in patients with type 2 diabetes, as compared to glimepiride, a widely used oral antidiabetic drug.
Week 23
BioInvent and ThromboGenics Report Positive Phase I Results for Anti-PlGF Cancer Therapeutic TB-403
3 June - BioInvent International AB and co-development partner ThromboGenics NV have reported that the results from the first Phase l study of novel anti-cancer agent TB-403 showed that it is safe and well tolerated, with pharmacokinetic properties enabling it to be developed for the treatment of cancer. The companies also announced that they have received approval from the regulatory authorities in Denmark to initiate a second repeat-dose Phase I clinical trial of TB-403 in patients with advanced solid tumours.
TopoTarget Reports Clinical Data Demonstrating Substantial Anti-Tumor Activity from a Phase II Trial
2 June - TopoTarget have announced positive data from its BelCaP (belinostat combined with standard doses of carboplatin and paclitaxel) program in patients with relapsed epithelial ovarian. BelCaP is well-tolerated presenting a safety profile consistent of that observed with chemotherapy alone.
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Preliminary Analyses from Phase 2 Genzyme Study Highlight Efficacy and Safety of Clofarabine in Older Adult AML Patients
2 June - Genzyme have reported preliminary data from a fully-enrolled pivotal, phase 2 study examining the safety and effectiveness of Clolar (Clofarabine) as a single agent in previously untreated, older adult patients with acute myelogenous leukemia. Results show that patients with unfavorable prognostic factors who received single agent clofarabine exhibited a 45 percent overall remission rate based on investigator assessment, with manageable treatment-related side effects.
Novo Nordisk and Neose Announce Completion of Initial Phase I Clinical Trial of NN7128
2 June - Novo Nordisk and Neose Technologieshave have announced that Novo Nordisk has completed the initial Phase 1 clinical trial with NN7128 (GlycoPEGylated factor VIIa), a long-acting version of NovoSeven coagulation factor FVIIa (recombinant) administered intravenously. In the trial a significant prolongation of the half-life of NN7128 was observed. Furthermore, single doses of NN7128 were well tolerated with no serious adverse events.
Bavarian Nordic enters clinical trials with prostate cancer vaccine
3 June - Bavarian Nordic's subsidiary, BN ImmunoTherapeutics has initiated Phase I/II clinical studies with its therapeutic vaccine candidate against prostate cancer. A Phase I/II safety and tolerability study in 18 male patients with non-metastatic as well as hormone-insensitive prostate cancer has begun enrolment in the US. Secondary objectives of the trial include examining the ability of the vaccine to induce prostate antigen-specific immune responses, as well as clinical anti-tumor activity. Preliminary data is expected during second half year 2009.
