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Phase III study: GARDASIL prevents 77.5% of pre-cursor lesions to anal cancer

In a new phase III study, GARDASIL(R) (Quadrivalent Human Papillomavirus (Types 6, 11, 16 and 18) Recombinant Vaccine) prevented 77.5 per cent of anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men.

17 Feb 2010

Phase II clinical trial result of abiraterone drug shows promise for advanced prostate cancer

New results from a phase II clinical trial of the prostate cancer drug abiraterone suggest that it may help men with advanced disease who have tried standard treatments.

17 Feb 2010

ITS secures £8.65M Series-A equity funding round extension to fund synthetic flu vaccine study

Immune Targeting Systems (ITS) Limited (“ITS”), one of the leading developers of synthetic vaccines for mutating viruses, today announced it had secured a Series-A equity funding round extension for £8.65m which brings the total Series A financing to £13.15m. The company’s key investors HealthCap (Sweden), London Technology Fund (UK), Novartis Venture Fund (US & Basel) and Truffle Capital (France) are all participating. The round will be kept open until mid-2010 for new potential investors to invest.

17 Feb 2010

Generx clinical development opportunities: bioRASI to assist Cardium

Cardium Therapeutics today announced that it has entered into an agreement with bioRASI, an international contract research organization, to assist Cardium in the evaluation of Generx clinical development opportunities within major newly-industrializing markets in Eastern Europe, Asia and Latin America, for patients with chronic coronary artery disease who are either not optimal candidates for or do not have access to costly angioplasty/stenting or cardiac bypass surgery procedures.

17 Feb 2010

Cancer Research UK, immatics Biotechnologies sign collaboration agreement to trial IMA950 vaccine for GMB

CANCER RESEARCH UK and Cancer Research Technology - the charity's development and commercialisation arm - have reached a collaboration agreement with immatics Biotechnologies to trial their new treatment vaccine, IMA950, for glioblastoma multiforme (GMB), one of the most common forms of brain cancer.

16 Feb 2010

Positive topline data from Alkermes' phase 1 clinical study of ALKS 37 announced

Alkermes, Inc. today announced positive topline data from a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC).

16 Feb 2010

Oncolytics Biotech receives U.K. MHRA approval for REOLYSIN combination Phase 3 trial

Oncolytics Biotech Inc. today announced that it has received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. This is the same trial that the Company previously reached an agreement on with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process.

16 Feb 2010

MAP Pharmaceuticals initiates LEVADEX-intravenous DHE comparative trial

MAP Pharmaceuticals, Inc. today announced that the Company initiated a trial to compare the pharmacokinetics (PK), safety and metabolic profiles of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.

16 Feb 2010

Octapharma initiates Phase III studies for new, high purity IVIG in treatment of primary immune deficiency

Octapharma AG today announced the start of the first of a series of Phase III studies for its new 10% high purity intravenous immunoglobulin (IVIG). The study will investigate the efficacy and safety of this novel immunoglobulin in the treatment of primary immune deficiency and, together with results from additional upcoming studies, will support its regulatory filing in Europe and the US.

16 Feb 2010

Positive interim results from Helix BioPharma's Topical Interferon Alpha-2b Phase II pharmacokinetic study

Helix BioPharma Corp. today announced that the first ten patients that have been enrolled in its Phase II pharmacokinetic study of Topical Interferon Alpha-2b in patients with low-grade cervical lesions have completed the pharmacokinetic primary endpoint analyses with positive findings.

14 Feb 2010

Debiopharm receives AFSSAPS approval of CTA for Debio 0932 inhibitor, triggers milestone payment to Curis

Curis, Inc., announced today that its licensee Debiopharm S.A. has received approval from France's regulatory authority Agence Française de Securité Sanitaire des Produits de Santé (AFSSAPS) of a Clinical Trial Application (CTA) for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305. Under the terms of Curis’ and Debiopharm’s August 2009 license agreement, Curis will receive an $8 million milestone payment from Debiopharm for the achievement of this development objective.

12 Feb 2010

Viral Genetics: Company update

Our mission is to bring new drug compounds to the marketplace. And we've never been in a stronger position to deliver on that promise. We've built the solid foundation needed to take drug therapies from the laboratory to the marketplace. After years in development, we believe several of our most promising compounds are moving closer to clinical trials.

12 Feb 2010

Encouraging results from Circassia's ToleroMune ragweed allergy T-cell vaccine phase II clinical trial

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that its ToleroMune(R) ragweed allergy T-cell vaccine achieved positive results in a recently completed phase II clinical trial. Ragweed allergy is particularly common in America, where it affects approximately 25% of the population. Circassia's latest clinical results follow two earlier successful phase II studies with the company's T-cell vaccine against cat allergy.

12 Feb 2010

Peregrine Pharmaceuticals' Cotara specifically targets solid tumors and anti-tumor activity

Peregrine Pharmaceuticals, Inc. (PPHM) today reported publication of data in the online edition of the journal Current Cancer Therapy Reviews that supports the clinical potential of the company's novel brain cancer agent Cotara® for the treatment of patients with glioblastoma multiforme (GBM), the deadliest form of brain cancer. Cotara specifically targets cells at the center of brain tumors, so its radioactive payload is able to kill cancer cells while leaving healthy tissue largely unaffected. Cotara is currently being tested in a Phase II clinical trial in recurrent GBM patients.

12 Feb 2010

Third party reexamination of Phase III study of Ereska meets primary endpoint

Javelin Pharmaceuticals, Inc. today announced that a reexamination conducted by a third party of pain score measurements from its Phase III study of Ereska™ (intranasal ketamine) showed that top line results for its primary endpoint were statistically significant. Previously, Javelin had reported that the top line results for its primary endpoint were not statistically significant.

12 Feb 2010

Genzyme announces 2-year data from eliglustat tartrate Phase 2 trial for Gaucher disease

Genzyme Corporation announced today two-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate (formerly Genz-112638). Continued improvements were observed across all endpoints, including bone disease, at the two-year timepoint, compared with baseline. The two-year results were presented for the first time today at the Lysosomal Disease Network WORLD Symposium in Miami, Fla.

12 Feb 2010

Positive results from Shire's velaglucerase alfa Phase III study for Type 1 Gaucher disease

Shire plc, the global specialty biopharmaceutical company, today presented positive results from its first Phase III study (TKT 032) evaluating safety and efficacy of velaglucerase alfa, its investigational enzyme replacement therapy for the treatment of Type 1 Gaucher disease. The data were presented in an oral presentation at the Lysosomal Disease Network (LDN) World Symposium in Miami, Florida.

12 Feb 2010

NMDP Phase III filgrastim trial: Biologics to provide pharmacy management services

Biologics, Inc., the leading cancer management company in the United States, announces that its Oncology Clinical Trial Services division has been selected by the National Marrow Donor Program® (NMDP), a nonprofit organization that facilitates unrelated hematopoietic cell transplants.

12 Feb 2010

Second-quarter fiscal 2010 results announced by Pharmacyclics

Pharmacyclics, Inc. today reported financial results for its second fiscal quarter ended December 31, 2009.

12 Feb 2010

Additional data from Phase III clinical trial of taliglucerase alfa in patients with Gaucher disease presented

Protalix BioTherapeutics, Inc., announced today that additional data from the Company's pivotal Phase III clinical trial of taliglucerase alfa in patients with Gaucher disease was presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2010 in Miami, Florida, during an oral session titled, "Novel Enzyme Replacement Therapy for Gaucher Disease: Phase III Pivotal Clinical Trial with Plant Cell Expressed Recombinant Glucocerebrosidase (prGCD) - taliglucerase alfa."

12 Feb 2010

Drug Trial News

Phase III study: GARDASIL prevents 77.5% of pre-cursor lesions to anal cancer

Phase II clinical trial result of abiraterone drug shows promise for advanced prostate cancer

ITS secures £8.65M Series-A equity funding round extension to fund synthetic flu vaccine study

Generx clinical development opportunities: bioRASI to assist Cardium

Cancer Research UK, immatics Biotechnologies sign collaboration agreement to trial IMA950 vaccine for GMB

Positive topline data from Alkermes' phase 1 clinical study of ALKS 37 announced

Oncolytics Biotech receives U.K. MHRA approval for REOLYSIN combination Phase 3 trial

MAP Pharmaceuticals initiates LEVADEX-intravenous DHE comparative trial

Octapharma initiates Phase III studies for new, high purity IVIG in treatment of primary immune deficiency

Positive interim results from Helix BioPharma's Topical Interferon Alpha-2b Phase II pharmacokinetic study

Debiopharm receives AFSSAPS approval of CTA for Debio 0932 inhibitor, triggers milestone payment to Curis

Viral Genetics: Company update

Encouraging results from Circassia's ToleroMune ragweed allergy T-cell vaccine phase II clinical trial

Peregrine Pharmaceuticals' Cotara specifically targets solid tumors and anti-tumor activity

Third party reexamination of Phase III study of Ereska meets primary endpoint

Genzyme announces 2-year data from eliglustat tartrate Phase 2 trial for Gaucher disease

Positive results from Shire's velaglucerase alfa Phase III study for Type 1 Gaucher disease

NMDP Phase III filgrastim trial: Biologics to provide pharmacy management services

Second-quarter fiscal 2010 results announced by Pharmacyclics

Additional data from Phase III clinical trial of taliglucerase alfa in patients with Gaucher disease presented

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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