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ChemoCentryx reports one-year study results of Traficet-EN in Crohn's disease patients

ChemoCentryx, Inc., today announced that it reported one-year results from the Company's PROTECT-1 Study (the Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial) of Traficet-EN™ (CCX282-B) in patients with moderate-to-severe Crohn's disease. Traficet-EN, an orally bioavailable CCR9-specific chemokine receptor antagonist showed clinical efficacy in a 12-week Induction period, as well as a 36-week Maintenance period.

28 Oct 2010

EpiCept, FDA reach agreement on regulatory path forward for Ceplene

EpiCept Corporation today announced that it has reached an agreement on all outstanding issues with the U.S. Food and Drug Administration (FDA) on a regulatory path forward for Ceplene® (histamine dihydrochloride), the Company's lead product for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first complete remission. Ceplene® is approved in the European Union for this indication and is marketed there by Meda AB.

28 Oct 2010

Nymox updates NX-1207 Phase 3 pivotal trials for benign prostatic hyperplasia

Nymox Pharmaceutical Corporation provided an update today on the Company's Phase 3 pivotal trials for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH).

28 Oct 2010

New oral drug shrinks IMT sarcoma driven by abnormally activated protein

A new oral drug caused dramatic shrinkage of a patient's rare, aggressive form of soft-tissue cancer that was driven by an abnormally activated protein, physician-scientists from Dana-Farber Cancer Institute report in the Oct. 28 issue of the New England Journal of Medicine.

28 Oct 2010

BDSI to initiate BEMA Buprenorphine Phase 3 program following positive End-of-Phase 2 meeting with FDA

BioDelivery Sciences International, Inc. today announced a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) which took place on September 14, 2010. At that meeting, agreement was reached on the BEMA Buprenorphine development plan for the treatment of chronic pain.

28 Oct 2010

Lotus receives Chinese SFDA approval for R-Bambuterol Hydrochloride Phase I human clinical trials

Lotus Pharmaceuticals, Inc., a fast-growing, profitable developer, manufacturer and seller of medicine and drugs in the People's Republic of China ("PRC"), announced today that it received approval from the State Food and Drug Administration ("SFDA") Ethics Committee to commence Phase I human clinical trials of R-Bambuterol Hydrochloride, the Company's proprietary drug candidate for the treatment of asthma.

28 Oct 2010

Vical to present preclinical results of HSV-2 vaccine program at Keystone Symposium

Vical Incorporated today announced that the company's Vice President of Clinical Development, Richard T. Kenney, M.D., is presenting preclinical results from the company's herpes simplex type 2 (HSV-2) vaccine program in a poster session Friday morning at the Keystone Symposium on Immunological Mechanisms of Vaccination (Seattle, October 27 – November 1).

27 Oct 2010

Intellect obtains initial draft report of OXIGON Phase 1b clinical trial for Alzheimer’s disease

Intellect Neurosciences, Inc. a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has obtained an initial draft report of the Company's Phase 1b clinical trial for its lead Alzheimer's candidate, OXIGON (OX1).

27 Oct 2010

MedAvante's centralized ratings to be used in Rexahn's Serdaxin Phase 2a study in MDD patients

MedAvante, Inc., the leader in centralized expert evaluation of central nervous system (CNS) disorders, and Rexahn Pharmaceuticals, Inc. a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, announced that Rexahn will use MedAvante 's Remote Centralized Ratings™ in their randomized, double-blind, placebo-controlled Phase 2b clinical study assessing the efficacy of Serdaxin® in patients with major depressive disorder (MDD).

27 Oct 2010

Oramed to present data on oral insulin formulation for Type II diabetes at Annual Meeting in Bethesda

Oramed Pharmaceuticals Inc. a developer of oral drug delivery systems, announced today that its work entitled "Extended exposure to an oral insulin formulation yields decreased insulin secretion in Type II diabetes subjects," will be presented at the Tenth Annual Meeting of the Diabetes Technology Society, to be held in Bethesda, Maryland this November.

27 Oct 2010

Oncolytics presents REO 013 clinical trial data for colorectal cancer at International Symposium in Spain

Oncolytics Biotech Inc. announced today that interim data from a U.K. translational clinical trial (REO 013) investigating intravenous administration of REOLYSIN in patients with metastatic colorectal cancer prior to surgical resection of liver metastases was presented at the International Symposium on Cytotoxic T-lymphocytes (CTL) and Immunostimulation being held in Pamplona, Spain.

27 Oct 2010

Keryx completes randomization of last patient in Zerenex Phase 3 study for hyperphosphatemia

Keryx Biopharmaceuticals reported today the randomization of the last patient in its short-term study component of its Phase 3 registration program of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis.

26 Oct 2010

Purdue and Mundipharma assume worldwide development for Infinity's fatty acid amide hydrolase program

Infinity Pharmaceuticals, Inc. today announced that Purdue Pharmaceutical Products L.P. and its independent associated company, Mundipharma International Corporation Ltd., have exercised their right to assume worldwide development and commercialization activities for Infinity's fatty acid amide hydrolase, or FAAH, program. The decision reflects progress made in the development of Infinity's oral FAAH inhibitor, IPI-940.

26 Oct 2010

Agile presents AG200-15 contraceptive patch Phase 2 clinical study results at 66th ASRM

Agile Therapeutics announced results today from a Phase 2 clinical study of AG200-15, Agile's weekly contraceptive patch containing ethinyl estradiol (EE) in combination with levonorgestrel (LNG). According to the clinical findings, AG200-15 provides a low daily dose of estrogen equivalent to 30 micrograms EE, similar to that in low-dose, oral contraceptive (OC) pills.

26 Oct 2010

TransPharma announces positive results of ViaDerm-hPTH Phase 1 trial for osteoporosis treatment

TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced today successful results of a 4 week Phase 1 trial of its new self-applied ViaDerm-hPTH(1-34) for the treatment of osteoporosis.

26 Oct 2010

Tengion presents data on Neo-Kidney Augment at Transplantation's Annual Scientific Exchange

Tengion, Inc. a leader in regenerative medicine, presented new data on Saturday, October 23, 2010 in a podium presentation at the American Society for Transplantation's Annual Scientific Exchange in Orlando, FL. The presentation highlighted new early data from Tengion's Neo-Kidney Augment development program demonstrating promising improvements in kidney function with an autologous cellular therapy approach to kidney regeneration in a canine model of chronic kidney disease.

26 Oct 2010

Phase II data from resminostat SAPHIRE study to be presented at International Hodgkin Lymphoma Symposium

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, announces the presentation of Phase II data from Hodgkin Lymphoma patients treated in the 1st Simon Stage cohort of the ongoing SAPHIRE study with resminostat (4SC-201), an oral pan-histone deacetylase (HDAC) inhibitor, at the 8th International Symposium on Hodgkin Lymphoma in Cologne, Germany.

26 Oct 2010

Genmab begins Phase III head to head study of ofatumumab vs. rituximab in follicular NHL

Genmab A/S announced today the start of a Phase III study of single agent ofatumumab compared to single agent rituximab in patients with follicular non-Hodgkin's lymphoma (NHL) that has relapsed at least 6 months after completion of treatment with a rituximab-containing regimen to which they responded.

26 Oct 2010

Celtic, Resolvyx enter option agreement for RX-10045 to treat dry eye syndrome

Celtic Therapeutics Holdings L.P. a successor firm to Celtic Pharma, and Resolvyx Pharmaceuticals, Inc. (Resolvyx) announced today that they have entered into an option agreement relating to Resolvyx's RX-10045, a late-stage program for the treatment of dry eye syndrome and other ophthalmic conditions.

26 Oct 2010

Sanofi-aventis commences teriflunomide Phase III study in RMS patients treated with interferon beta

Sanofi-aventis announced today the initiation of a multinational Phase III study evaluating the efficacy and safety of two doses of once daily teriflunomide (7mg or 14mg) versus placebo in patients with relapsing multiple sclerosis (RMS) treated with interferon beta (IFN beta).

26 Oct 2010

Drug Trial News

ChemoCentryx reports one-year study results of Traficet-EN in Crohn's disease patients

EpiCept, FDA reach agreement on regulatory path forward for Ceplene

Nymox updates NX-1207 Phase 3 pivotal trials for benign prostatic hyperplasia

New oral drug shrinks IMT sarcoma driven by abnormally activated protein

BDSI to initiate BEMA Buprenorphine Phase 3 program following positive End-of-Phase 2 meeting with FDA

Lotus receives Chinese SFDA approval for R-Bambuterol Hydrochloride Phase I human clinical trials

Vical to present preclinical results of HSV-2 vaccine program at Keystone Symposium

Intellect obtains initial draft report of OXIGON Phase 1b clinical trial for Alzheimer’s disease

MedAvante's centralized ratings to be used in Rexahn's Serdaxin Phase 2a study in MDD patients

Oramed to present data on oral insulin formulation for Type II diabetes at Annual Meeting in Bethesda

Oncolytics presents REO 013 clinical trial data for colorectal cancer at International Symposium in Spain

Keryx completes randomization of last patient in Zerenex Phase 3 study for hyperphosphatemia

Purdue and Mundipharma assume worldwide development for Infinity's fatty acid amide hydrolase program

Agile presents AG200-15 contraceptive patch Phase 2 clinical study results at 66th ASRM

TransPharma announces positive results of ViaDerm-hPTH Phase 1 trial for osteoporosis treatment

Tengion presents data on Neo-Kidney Augment at Transplantation's Annual Scientific Exchange

Phase II data from resminostat SAPHIRE study to be presented at International Hodgkin Lymphoma Symposium

Genmab begins Phase III head to head study of ofatumumab vs. rituximab in follicular NHL

Celtic, Resolvyx enter option agreement for RX-10045 to treat dry eye syndrome

Sanofi-aventis commences teriflunomide Phase III study in RMS patients treated with interferon beta

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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