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MGH, Iacocca Foundation complete Phase I BCG clinical trial in type 1 diabetes

Massachusetts General Hospital (MGH) and the Iacocca Foundation announce today the completion of the Phase I BCG clinical trial in type 1 diabetes, as well as the submission of all safety reports to the U.S. Food and Drug Administration (FDA) and the MGH data safety monitoring boards. Plans for the Phase II clinical study, which will continue the investigation of bacillus Calmette-Guerin (BCG) vaccination as a treatment for people with existing type 1 diabetes, are actively underway.

29 Jun 2010

BioAlliance Pharma presents abstracts on Loramyc, clonidine Lauriad at MASCC/ISOO 2010 symposium

BioAlliance Pharma SA, a company dedicated to the supportive care and treatment of cancer patients, has presented 2 abstracts on Loramyc® and clonidine Lauriad® at the MASCC/ISOO 2010 International Symposium (Vancouver, June 24-26, 2010). These two products belong to the supportive care pipeline of BioAlliance Pharma.

29 Jun 2010

Forest Laboratories, Gedeon Richter report positive results from radiprodil Phase II study for DPNP pain

Forest Laboratories, Inc. and Gedeon Richter Plc. today announced top-line results from a Phase II placebo and positive comparator-controlled, parallel-arm, double-blind, dose-response clinical trial of the novel, investigational NR2B-selective NMDA (N-methyl D-aspartate) receptor antagonist, radiprodil (RGH-896), for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPNP).

29 Jun 2010

Cell>Point completes cancer diagnostic phase 2 trial; reports favorable trends in primary tumor imaging

Cell>Point announced today that it has closed the Phase 2 portion of its Phase 2/3 trial of 99mTc-EC-G in evaluating patients with non-small cell lung cancer.

29 Jun 2010

ITMTX treatment effective in late stages/progressive forms of MS: Study

The Multiple Sclerosis Research Center of New York (MSRCNY), together with the International Multiple Sclerosis Management Practice (IMSMP), today announced that results from its Intrathecal Methotrexate Treatment in Multiple Sclerosis study have been published in this month's issue of Journal of Neurology. This study reports on the feasibility of using intrathecal methotrexate (ITMTX) in treatment unresponsive multiple sclerosis (MS) patients with progressive forms of the disease.

28 Jun 2010

Intarcia presents ITCA 650 Phase 2 study results at 70th ADA

Intarcia Therapeutics, Inc. presented today the results of a phase 2 clinical study of ITCA 650 (DUROS® continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes as a late-breaker at the Annual Conference of the American Diabetes Association in Orlando, FL (June 25-29, 2010). Results of the phase 2 study demonstrated substantial reductions in HbA1c and body weight during the 12 weeks of treatment with ITCA 650 at both the 20 mcg/day and 40 mcg/day doses.

28 Jun 2010

Zeria reports positive results from Japanese Phase III study of Z-338 for functional dyspepsia

Zeria Pharmaceutical announced today positive results of their Japanese Phase III study of Z-338 (acotiamide hydrochloride hydrate; "acotiamide") for the treatment of functional dyspepsia (FD). FD is a gastrointestinal disease comprised of subjective symptoms including postprandial fullness, early satiation and epigastric pain without any organic abnormality on gastrointestinal tract.

28 Jun 2010

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

Drug Trial News

MGH, Iacocca Foundation complete Phase I BCG clinical trial in type 1 diabetes

BioAlliance Pharma presents abstracts on Loramyc, clonidine Lauriad at MASCC/ISOO 2010 symposium

Forest Laboratories, Gedeon Richter report positive results from radiprodil Phase II study for DPNP pain

Cell>Point completes cancer diagnostic phase 2 trial; reports favorable trends in primary tumor imaging

ITMTX treatment effective in late stages/progressive forms of MS: Study

Intarcia presents ITCA 650 Phase 2 study results at 70th ADA

Zeria reports positive results from Japanese Phase III study of Z-338 for functional dyspepsia

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

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