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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

Amicus Therapeutics presents additional data from Amigal Phase 2 extension study for Fabry disease

Amicus Therapeutics announced today additional positive preliminary data from its ongoing Phase 2 extension study of its investigational drug Amigal™ (migalastat HCl) for Fabry disease at the Lysosomal Disease Network WORLD Symposium in Miami, Florida.

11 Feb 2010

PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

PARI Pharma has enrolled the first patient in its Phase 2b clinical trial studying inhaled liposomal cyclosporine A (L-CsA) delivered via a customized Investigational eFlow Nebulizer System. The multinational study is investigating the safety and efficacy of PARI's L-CsA formulation. In previous clinical trials, reactions from physicians and lung transplant recipients to PARI's drug-device combination were encouraging.

11 Feb 2010

3SBio submits application for Phase I clinical trial of NuPIAO to the Chinese SFDA

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a Phase I clinical trial for NuPIAO to the Chinese State Food and Drug Administration (SFDA).

11 Feb 2010

YM Biosciences to present JAK1/2 inhibiting small molecule and vascular disrupting agent data at Cancer Conference

YM BioSciences Inc., is presenting posters on its JAK1/2 inhibiting small molecule (CYT387) and on its novel vascular disrupting agent (CYT997) at the Lorne Cancer Conference in Lorne, Victoria, Australia. CYT387 is an oral JAK1/2 inhibitor, originating from the seminal discovery of JAK1 and JAK2 kinases by Dr. Andrew Wilks, the founder of Cytopia Limited, now YM Australia. CYT997 is an orally-available agent with dual mechanisms of vascular disruption and cytotoxicity and has the potential to be broadly active against a range of tumor types.

11 Feb 2010

Biodel's VIAject insulin Phase 3 study results to be presented at international diabetes conference in Basel

Biodel, Inc. announced today that its chief executive officer, Dr. Sol Steiner, will present results from the company’s two Phase 3 studies with VIAject® ultra-rapid-acting recombinant human insulin in a platform presentation at the 3rd International Conference on Advanced Technologies and Treatments for Diabetes in Basel, Switzerland, on Friday, February 12, 2010, at 1pm central European time.

11 Feb 2010

4SC AG announces the first treatment in Phase I clinical study of 4SC-205

4SC AG a drug discovery and development company focused on autoimmune and cancer indications, today announced the first treatment in a Phase I study evaluating 4SC-205, an oral Eg5 kinesin spindle protein inhibitor, in patients with solid tumours or malignant lymphomas.

11 Feb 2010

Drug Trial News

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

Amicus Therapeutics presents additional data from Amigal Phase 2 extension study for Fabry disease

PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

3SBio submits application for Phase I clinical trial of NuPIAO to the Chinese SFDA

YM Biosciences to present JAK1/2 inhibiting small molecule and vascular disrupting agent data at Cancer Conference

Biodel's VIAject insulin Phase 3 study results to be presented at international diabetes conference in Basel

4SC AG announces the first treatment in Phase I clinical study of 4SC-205

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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