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Phase III study evaluating PEP005 Gel for treatment of AK meets primary clinical endpoint

LEO Pharma today announced that in a Phase III study, PEP005 (ingenol mebutate) Gel, the company's lead candidate for the topical treatment of actinic (solar) keratosis (AK) or pre-cancerous lesions, met its primary clinical endpoint of complete clearance of AK lesions in non-head locations.

2 Feb 2010

Pervasis Therapeutics reaches agreement with FDA on pivotal Phase 3 clinical trial for Vascugel

Pervasis Therapeutics, Inc. today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a pivotal Phase 3 clinical trial for Vascugel®, an investigational new drug for the prevention of hemodialysis access graft failure.

2 Feb 2010

Romark Laboratories commences enrollment in Alinia clinical trial for acute uncomplicated influenza

Romark Laboratories announced that it has initiated enrollment of patients in a clinical trial of Alinia® (nitazoxanide) for treating acute uncomplicated influenza including illness caused by the currently circulating H1N1 strain.

1 Feb 2010

Interim positive data from Phase IIa clinical study of SYN115 for Parkinson’s disease

Synosia Therapeutics today announced interim positive data from a Phase IIa clinical study of an adenosine 2a (A2a) receptor antagonist (SYN115) in Parkinson’s disease.

1 Feb 2010

Clinical results of MedImmune's pivotal trial for motavizumab published

MedImmune today announced that clinical results of its pivotal multinational, randomized, double-masked trial for motavizumab have been published in the current issue of the peer-reviewed publication, Pediatrics: Official Journal of the American Academy of Pediatrics.

30 Jan 2010

$Perifosine holds promise as a single agent for relapsed/refractory Waldenstrom's Macroglobulinemia$

Perifosine holds promise as a single agent for relapsed/refractory Waldenstrom's Macroglobulinemia

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrinology, today announced that an article entitled "Clinical and Translational Studies of a Phase II Trial of the Novel Oral Akt Inhibitor Perifosine in Relapsed or Relapsed/Refractory Waldenstrom's Macroglobulinemia," reporting Phase 2 data demonstrating the single agent activity of perifosine (KRX-0401) for the treatment of advanced Waldenstrom's Macroglobulinemia ("Waldenstrom's"), will appear in the February 1, 2010 issue of the Journal of Clinical Cancer Research.

30 Jan 2010

Positive Phase 2 trial results of Keryx Biopharmaceuticals' KRX-0401 announced

Keryx Biopharmaceuticals, Inc. (the "Company") today announced that an article entitled "Clinical and Translational Studies of a Phase II Trial of the Novel Oral Akt Inhibitor Perifosine in Relapsed or Relapsed/Refractory Waldenstrom's Macroglobulinemia," reporting Phase 2 data demonstrating the single agent activity of KRX-0401 (Perifosine) for the treatment of advanced Waldenstrom's Macroglobulinemia ("Waldenstrom's"), will appear in the February 1, 2010 issue of Clinical Cancer Research.

29 Jan 2010

New guidance may help minimize risks to patient privacy in clinical trials

New guidance published in the open access journal Trials and bmj.com this week sets out how personal information from clinical trials should be shared to help minimize risks to patient privacy.

29 Jan 2010

Diabetes vaccine: Diamyd Medical to file for market approval in 2011

In her comments in today’s quarterly report Elisabeth Lindner, President and CEO of Diamyd Medical, says that the Company’s objective is to file the Diamyd® diabetes vaccine for market approval in 2011 - a goal that isn’t very far off now.

29 Jan 2010

Merge Healthcare deploys etrials eDiary 5.0 platform for global urology clinical trial

Merge Healthcare has successfully deployed its etrials eDiary 5.0 platform to conduct a global Phase II urology clinical trial involving 750 patients for one of the largest pharmaceutical companies in the world. Merge was awarded the project because of its eDiary technology, experience in global ePRO (electronic patient reported outcomes) trials and ability to manage the complex logic required by this study. Underway in 22 countries on 3 continents and in 34 languages, the trial also utilizes Merge’s new eDiary Inventory Module to track shipping and supply of study devices in real-time.

29 Jan 2010

Conatus Pharmaceuticals initiates combination trial of CTS-1027 with pegylated interferon and ribavirin for HCV

Conatus Pharmaceuticals Inc. announced today the initiation of a Phase II clinical trial evaluating CTS-1027 in combination with pegylated interferon (Pegasys®) and ribavirin (Copegus®) in refractory HCV patients. Antiviral activity, safety and tolerability of the triple combination will be assessed after up to 48 weeks of therapy.

28 Jan 2010

ChemoCentryx announces the initiation of Phase I clinical trial of CCX168

ChemoCentryx, Inc., today announced the initiation of a Phase I clinical trial of CCX168, an orally-administered small molecule designed to treat autoimmune diseases.

28 Jan 2010

Zelos Therapeutics commences dosing in clinical study of ZT-034 nasal spray for osteoporosis

Zelos Therapeutics, Inc. has initiated dosing in a seven day clinical study of a nasal spray formulation of ZT-034 (teriparatide) that is being developed in collaboration with development partner Aegis Therapeutics, LLC. Nasal spray ZT-034 is being developed as an alternative to Eli Lilly and Company’s Forteo (teriparatide [rDNA origin]) which generated approximately $800M in annual sales in 2009 for the treatment of osteoporosis and is administered by daily injection.

28 Jan 2010

NIDA supports Omeros' Addiction program

Omeros Corporation today announced that the National Institute on Drug Abuse (NIDA) is providing support for the Company's Addiction program. NIDA will fund substantially all of the costs of a Phase 2 clinical study to be conducted by New York State Psychiatric Institute researchers.

28 Jan 2010

Neovasc to fund proceeds of its non-brokered private placement for COSIRA trial

Neovasc Inc. today announced that it has completed the first tranche of a previously announced non-brokered private placement of approximately 7.4 million units at the price of $0.27 per unit for aggregate gross proceeds of up to $2.0 million.

28 Jan 2010

Idera Pharmaceuticals commences IMO-3100 Phase 1 clinical trial for autoimmune diseases

Idera Pharmaceuticals, Inc. today announced initiation of a Phase 1 clinical trial of IMO-3100, an antagonist of Toll-like Receptor (TLR) 7 and TLR9.

28 Jan 2010

Anacor Pharmaceuticals to present data on its PDE4 inhibitor at the Cytokines and Inflammation Conference

Anacor Pharmaceuticals announced today that it will present a poster and oral presentation on a novel systemic anti-inflammatory candidate, AN6415, at the upcoming 8th Cytokines and Inflammation Conference, taking place January 28-29, 2010 in La Jolla, California.

28 Jan 2010

Men welcome male contraceptive pill currently undergoing trials

Would you trust men to take a 'male pill'? That's the question posed to 380 people in North East England by a team from Teesside University which questioned people about the male contraceptive pill currently undergoing trials.

28 Jan 2010

GENFIT's GFT505 exhibits potential to address unmet needs in prediabetic and diabetic patients

GENFIT, a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and neurodegenerative diseases, today announces positive results from a recently completed clinical trial demonstrating the activity of GFT505 on glucose homeostasis. Results from the clinical trial (GFT505-2094) clearly demonstrate the potential of the drug candidate to reduce global cardiovascular risk in prediabetic patients who suffer from impaired fasting plasma glucose, impaired glucose tolerance, and abdominal obesity.

28 Jan 2010

Positive results from Supernus Pharmaceuticals' SPN 810 Phase IIa trial for ADHD

Supernus Pharmaceuticals Inc., today announced that its Phase IIa U.S. clinical trial for SPN 810 in children with ADHD and persistent serious conduct problems met the primary endpoints of safety and tolerability, as well as showed statistically significant reduction versus baseline in conduct problems across all doses. The trial was initiated in 2009 and was a proof-of-concept, open-label study in children 6 to 12 years of age, assigned to one of four doses over a six-week treatment period, after 2-5 weeks' titration.

27 Jan 2010

Drug Trial News

Phase III study evaluating PEP005 Gel for treatment of AK meets primary clinical endpoint

Pervasis Therapeutics reaches agreement with FDA on pivotal Phase 3 clinical trial for Vascugel

Romark Laboratories commences enrollment in Alinia clinical trial for acute uncomplicated influenza

Interim positive data from Phase IIa clinical study of SYN115 for Parkinson’s disease

Clinical results of MedImmune's pivotal trial for motavizumab published

Perifosine holds promise as a single agent for relapsed/refractory Waldenstrom's Macroglobulinemia

Positive Phase 2 trial results of Keryx Biopharmaceuticals' KRX-0401 announced

New guidance may help minimize risks to patient privacy in clinical trials

Diabetes vaccine: Diamyd Medical to file for market approval in 2011

Merge Healthcare deploys etrials eDiary 5.0 platform for global urology clinical trial

Conatus Pharmaceuticals initiates combination trial of CTS-1027 with pegylated interferon and ribavirin for HCV

ChemoCentryx announces the initiation of Phase I clinical trial of CCX168

Zelos Therapeutics commences dosing in clinical study of ZT-034 nasal spray for osteoporosis

NIDA supports Omeros' Addiction program

Neovasc to fund proceeds of its non-brokered private placement for COSIRA trial

Idera Pharmaceuticals commences IMO-3100 Phase 1 clinical trial for autoimmune diseases

Anacor Pharmaceuticals to present data on its PDE4 inhibitor at the Cytokines and Inflammation Conference

Men welcome male contraceptive pill currently undergoing trials

GENFIT's GFT505 exhibits potential to address unmet needs in prediabetic and diabetic patients

Positive results from Supernus Pharmaceuticals' SPN 810 Phase IIa trial for ADHD

Advancing Motor Neuron Disease Diagnosis with Non-Invasive Ultrasound and AI

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

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