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pharmafile | September 10, 2007 | News story | Research and Development, Sales and Marketing |
Akela reports positive results for Fentanyl Taifun trial
Akela Pharma has reported promising results from a phase IIb trial for its pain relief drug candidate Fentanyl Taifun.
Akela says the results demonstrated statistically significant differences compared to placebo in the measured primary and secondary efficacy variables, resulting in faster and superior pain relief. Fentanyl Taifun is a fast-acting Fentanyl formulation delivered using the company's Taifun dry powder inhaler platform.
A total of 50 patients were randomised and started the extension part of the study. In the intent-to-treat population, the median time to significant pain relief in the Fentanyl Tainfun group as measured by a decrease of at least two points on the numerical pain scale was 5.2 minutes, which was statistically significantly faster when compared to placebo.
The mean difference in sum of pain intensity difference was also statistically significantly in favour of Fentanyl Taifun for the whole 60-minute pain episode. This was already seen in numerical pain scale scores up to 15 minutes when compared to placebo.
"The additional knowledge and data accumulated during this clinical trial, as well as the positive feed-back by the authorities during the recent end-of-phase II meetings makes us confident when preparing our phase III study protocols," said Dr Halvor Jaeger, CEO of Akela Pharma.
Related links
Central Nervous System – Pain Drug Pipeline Report
The Pain Market Outlook to 2011
Neuropathic Pain – A Plethora of Patient Segmentation and Product Differentiation Opportunities
AtheroGenics heart drug has minor effect on diabetics
AtheroGenics has reported new data from a trial of its failed heart drug candidate which suggests that the drug also has a limited effect in treating diabetes.
Data from the phase III trial showed that, at 12 months, AGI-1067 delivered only a minor reduction in glycated haemoglobin A1c, a commonly used measure of glycaemic control.
Lars Ryden, professor of cardiology at the Karolinska Institute in Stockholm, told Reuters he was unconvinced by the findings. "It's a small reduction of glycated haemoglobin. The impact on glucose control is so small that it is not very interesting in itself."
However, the drug did reduce the development of new onset diabetes in patients with impaired fasting glucose, a condition which is a precursor to diabetes, by 59%.
Diabetic patients taking the drug also demonstrated a 22% reduction in hard cardiovascular events of cardiovascular death, cardiac arrest, myocardial infarction and stroke.
"We believe that the unique mechanism of action for AGI-1067 may provide multiple therapeutic benefits for patients with diabetes," said Rob Scott, executive vice president of R&D and chief medical officer.
Related links
AtheroGenerics Inc: LSA company profile
The Diabetes Market Outlook to 2011
Non-insulin Antidiabetics – Type 2 diabetes unlikely to develop into a switch market
Pfizer to study Sutent in combination with Tarceva
Pfizer has started a global phase III trial to evaluate the efficacy and safety of Sutent, in combination with Genentech's Tarceva, in previously treated patients with advanced non-small cell lung cancer.
The phase III trial of 956 patients is designed to compare the overall survival of patients taking Sutent (sunitinib) in combination with Tarceva (erlotinib) with those taking erlotinib plus placebo. Secondary endpoints of the study include progression-free survival, objective response rate, one-year survival, duration of response, adverse events and patient-reported outcomes.
In addition, preliminary results from a phase II study evaluating the safety and tolerability of sunitinib combined with erlotinib in patients with advanced non-small cell lung cancer (NSCLC), found that adverse events were mild to moderate. Two patients experienced partial responses, while two patients experienced stable disease.
"We are encouraged by the early data we are seeing for sunitinib in NSCLC," said Charles Baum, head of oncology development at Pfizer. "Pfizer is committed to further exploring the potential role of sunitinib in advanced NSCLC through the initiation of SUN 1087, a global, phase III study."
Lung cancer is the leading cause of cancer in men and women around the globe. Nearly 60% of NSCLC patients are diagnosed late with stage IIIB/IV advanced disease and most have evidence of distant metastases at the time of diagnosis.
Related links
Pfizer Inc: LSA company profile
Genentech Inc: LSA company profile
Non-Small-Cell Lung Cancer or Lung Cancer or Small Cell Lung Cancer Drug Pipeline Report
Non-Small Cell Lung Cancer – Angiogenesis and signal transduction inhibitors to expand market
Ardea Biosciences says phase I HIV drug trial success
Ardea Biosciences has successfully completed phase I trials of its investigational HIV drug, which the company said showed potent antiviral activity.
The trial involved single-ascending-dose, multiple-ascending-dose, food-effect, and drug-interaction studies evaluating RDEA806 is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) for the potential treatment of HIV infection. Based on preclinical and clinical studies to date, Ardea believes that RDEA806 possesses several attractive attributes.
These include: potent antiviral activity against a wide range of HIV viral isolates; the potential to be administered in a patient-friendly, oral dosing regimen; limited pharmacokinetic interactions with other drugs; and the ability to be co-formulated with other HIV antiviral drugs.
"We are very encouraged by our phase I clinical trial results in healthy volunteers. Based on these results, we plan to initiate a phase IIa proof-of-concept study of RDEA806 in HIV-infected patients before the end of this year, the results of which may be available by the first quarter of 2008. Assuming positive results, a larger phase IIb study in HIV-infected patients could start in the second quarter of 2008," said Barry Quart, president and CEO of Ardea.
Related links
Infections – AIDS HIV Drug Pipeline Report
Commercial Insight: HIV – Reshaping Treatment Paradigms
The Global HIV/AIDS Market Outlook to 2012
Clinical Data sees positive results from pivotal depression drug trial
Clinical Data has announced positive results from a phase III study of its investigative compound Vilazodone for the treatment of depression. According to the company, the primary and supportive secondary efficacy endpoints were met in the study.
The randomised, double-blind, placebo-controlled study of 410 adult patients with major depressive disorder achieved the primary endpoint of mean change from baseline in the Montgomery-Asberg Depression Rating Scale total score compared to the placebo.
Vilazodone also met a key secondary endpoint during the study, as measured by mean change from baseline on the Hamilton Depression Rating Scale. These two rating scales are the most common psychometric measures of response to antidepressants.
The study also identified candidate biomarkers for a potential companion test for predicting the response to Vilazodone. According to Clinical Data, Vilazodone is the only compound that combines two mechanisms used as first and second-line treatments for mood disorders.
Drew Fromkin, president and CEO of Clinical Data, said: "This positive result with Vilazodone to date, coupled with our demonstrated ability to bring proprietary, pharmacogenetic tests to market, signals a new era for Clinical Data."
Carol Reed, Clinical Data's chief medical officer, added: "The implications for patients suffering from depression are exciting. We look forward to meeting with the FDA to discuss our remaining clinical trials programme in support of our NDA filing on this important new therapeutic candidate and on a potential genetically based companion diagnostic."
Related links
Clinical Data Inc: LSA company profile
Central Nervous System – Depression Drug Pipeline Report
Pipeline Insight: Depression – Novel drugs to grow third-line market
Commercial Insight: Depression -Atypical lifecycle management strategy rejuvenates depression market
