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Eisai, Morphotek receive clearance for MORAb-022 Phase I clinical trial for rheumatoid arthritis

Eisai Inc. and Morphotek®, Inc. announced today that the Medical Ethical Review Committee and Central Committee on Research Involving Human Subjects of the Netherlands cleared its Clinical Trial Application to test the investigational new drug MORAb-022 in a Phase I clinical trial that will include both normal healthy volunteers and subjects diagnosed with rheumatoid arthritis.

28 Jun 2010

MorphoSys, Xencor sign worldwide exclusive license, collaboration agreement for XmAb5574 antibody program

MorphoSys AG and US-based biopharmaceutical company Xencor, Inc., announced today the signing of a worldwide exclusive license and collaboration agreement for an antibody in Phase 1 clinical development. The agreement provides MorphoSys with an exclusive worldwide license to XmAb5574, a high potency monoclonal antibody developed by Xencor for the treatment of B-cell malignancies.

28 Jun 2010

Clinical study results show no increased risk of CV events associated with SYMLIN injection

Amylin Pharmaceuticals, Inc. today announced results from an analysis of an integrated database of clinical studies that showed no increased risk of cardiovascular events associated with SYMLIN (pramlintide acetate) injection use compared to a pooled comparator group treated with either placebo or rapid-acting insulin. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

Tolerx presents data from otelixizumab Phase 3 DEFEND-1 clinical trial in type 1 diabetes patients

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today presented an analysis of baseline data from the Phase 3 DEFEND-1 clinical trial of otelixizumab in patients with autoimmune new onset type 1 diabetes.

28 Jun 2010

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA (exenatide) injection added to Lantus (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

Aeterna Zentaris, Almac collaborate on study of AEZS-108 doxorubicin LHRH targeted conjugate compound

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced a collaborative study with Almac's Diagnostics division for the Company's doxorubicin luteinizing hormone-releasing hormone (LHRH) targeted conjugate compound, AEZS-108, aimed at determining LHRH receptor expression through the development of a companion diagnostic tool.

28 Jun 2010

Tolerx initiates confirmatory Phase 3 clinical trial to evaluate otelixizumab in new-onset type 1 diabetes

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced the initiation of a confirmatory Phase 3 clinical trial to further evaluate otelixizumab in autoimmune new-onset type 1 diabetes. The confirmatory Phase 3 clinical trial is called DEFEND-2 (Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes) and immediately follows successful completion of enrollment in the initial Phase 3 clinical trial, DEFEND-1, with results from DEFEND-1 expected in the first half of 2011.

28 Jun 2010

RiVax intradermal administration protects from mucosal, systemic ricin intoxication

Soligenix, Inc., a late-stage biopharmaceutical company, announced today the publication of an article in the June 2010 edition of Vaccine, which describes protection from mucosal and systemic ricin intoxication by intradermal administration of RiVax™, the Company's vaccine against ricin toxin.

28 Jun 2010

ADVANCE study provides new insights into the management of SHPT in CKD patients

Results from the ADVANCE study presented in a late breaking clinical trial session at the ERA-EDTA 2010 Congress provide new insights into the management of secondary hyperparathyroidism in chronic kidney disease patients. ADVANCE (A randomiseD VAscular calcificatioN study to evaluate the effects of CinacalcEt) is a randomised, controlled open label study to evaluate the effects of treatment with Mimpara (cinacalcet) plus low-dose vitamin D, compared to flexible doses of vitamin D alone, on the progression of vascular and valvular calcification in dialysis patients with SHPT.

28 Jun 2010

Linagliptin mono- and combination therapy improves blood glucose control

Linagliptin phase III data were presented for the first time this week at the 70th Scientific Sessions of the American Diabetes Association (ADA), showing that this investigational compound, a dipeptidyl peptidase (DPP)-4 inhibitor, achieved significant, sustained and clinically meaningful reductions in blood glucose as measured by haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and postprandial glucose (PPG) concentrations.(1-6) Linagliptin is being investigated by Boehringer Ingelheim as a once-daily oral treatment in type 2 diabetes.

28 Jun 2010

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Raptor Pharmaceutical Corp. announced that it has enrolled the first patient in a pivotal Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

28 Jun 2010

Final results of VIAject vs. RHI Phase 3 study in type 2 diabetes patients presented at 70th ADA

The final results of a six-month, multi-center, open-label Phase 3 study of VIAject® (more-rapid-acting injectable human insulin) versus regular human insulin (RHI) in 471 patients with type 2 diabetes were presented today by Helena Rodbard, M.D., at the 70th Scientific Sessions of the American Diabetes Association. Dr. Rodbard was a principal investigator of this study, which was designed to evaluate the safety and efficacy of VIAject® versus regular human insulin when used in combination with insulin glargine.

28 Jun 2010

Halozyme presents new data from Ultrafast Insulin development program at 70th ADA

Halozyme Therapeutics, Inc. today announced Phase 2 results demonstrating that the subcutaneous coinjection of rHuPH20 (recombinant human hyaluronidase, PH20) with lispro significantly improves postprandial hyperglycemia, reduces hypoglycemia, and accelerates the absorption of mealtime insulin in patients with type 2 diabetes.

28 Jun 2010

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

Ipsen a global biopharmaceutical group, today announced that its partner Roche disclosed results of five Phase III 24-week studies for taspoglutide for type 2 diabetes at the American Diabetes Association's (ADA) 70th Annual Scientific Sessions. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen's research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.

28 Jun 2010

Orexigen Therapeutics announces data from CORDiabetes trial for Contrave

Orexigen Therapeutics, Inc. today announced data from the CORDiabetes trial for Contrave (naltrexone sustained release (SR)/bupropion SR) showing that after 56 weeks of treatment, overweight or obese patients with type 2 diabetes lost significantly more weight and achieved greater improvement in glycemic control than those treated with placebo.

28 Jun 2010

Arena's lorcaserin reduces body weight across patient subgroups

Arena Pharmaceuticals, Inc. today reported pooled Week 52 data from more than 6,000 patients in lorcaserin's pivotal Phase 3 clinical trial program that demonstrate lorcaserin 10 mg dosed twice daily reduced body weight in all patient subgroups evaluated, as defined by gender, age, ethnicity and starting body weight and Body Mass Index (BMI). Greater improvements in cardiovascular risk factors were also achieved with lorcaserin treatment compared to placebo overall and in most subgroups.

28 Jun 2010

Tolerx presents preclinical data on TRX518 anti-GITR immunotherapy for cancer

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, presented results from preclinical studies with TRX518, an early-stage agent Tolerx is developing as a treatment for cancer. TRX518 is a monoclonal antibody to glucocorticoid-induced tumor necrosis factor receptor (GITR) and is designed to enhance the immune system's ability to attack tumors by activating and rendering T effector cells resistant to T regulatory cell suppression.

28 Jun 2010

Phase 2 proof-of-concept data for Novo Nordisk's degludec presented at ADA 2010

Novo Nordisk today presented phase 2 proof-of-concept data for its investigational insulin degludec, an ultra-long-acting basal insulin, which demonstrated the potential to help achieve target glycemic control when used once daily or three times weekly. These data were presented at the 70th Scientific Sessions of the American Diabetes Association.

28 Jun 2010

Lantus and Apidra injections improve glycemic control, reduce hospital complications: Study

Sanofi-aventis announced today that results from the RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes Undergoing General Surgery (RABBIT-2 Surgery) found that treatment with a basal-bolus regimen that included Lantus (insulin glargine [rDNA origin] injection) once-daily and Apidra (insulin glulisine [rDNA origin] injection) before meals improved glycemic control and reduced hospital complications, compared to "sliding scale" insulin in general surgery patients with type 2 diabetes.

28 Jun 2010

Phase III clinical trials: Linagliptin achieves significant, sustained reductions in blood sugar

Data from four pivotal Phase III clinical trials demonstrate that linagliptin achieved statistically significant and sustained reductions in blood sugar as measured by hemoglobin A1c, fasting plasma glucose and postprandial glucose. Boehringer Ingelheim Pharmaceuticals, Inc. is investigating the dipeptidyl peptidase 4 inhibitor as an oral once-daily tablet, as monotherapy and combination therapy, to treat type 2 diabetes.

28 Jun 2010

Drug Trial News

Eisai, Morphotek receive clearance for MORAb-022 Phase I clinical trial for rheumatoid arthritis

MorphoSys, Xencor sign worldwide exclusive license, collaboration agreement for XmAb5574 antibody program

Clinical study results show no increased risk of CV events associated with SYMLIN injection

Tolerx presents data from otelixizumab Phase 3 DEFEND-1 clinical trial in type 1 diabetes patients

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Aeterna Zentaris, Almac collaborate on study of AEZS-108 doxorubicin LHRH targeted conjugate compound

Tolerx initiates confirmatory Phase 3 clinical trial to evaluate otelixizumab in new-onset type 1 diabetes

RiVax intradermal administration protects from mucosal, systemic ricin intoxication

ADVANCE study provides new insights into the management of SHPT in CKD patients

Linagliptin mono- and combination therapy improves blood glucose control

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Final results of VIAject vs. RHI Phase 3 study in type 2 diabetes patients presented at 70th ADA

Halozyme presents new data from Ultrafast Insulin development program at 70th ADA

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

Orexigen Therapeutics announces data from CORDiabetes trial for Contrave

Arena's lorcaserin reduces body weight across patient subgroups

Tolerx presents preclinical data on TRX518 anti-GITR immunotherapy for cancer

Phase 2 proof-of-concept data for Novo Nordisk's degludec presented at ADA 2010

Lantus and Apidra injections improve glycemic control, reduce hospital complications: Study

Phase III clinical trials: Linagliptin achieves significant, sustained reductions in blood sugar

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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