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Millennium commences Phase I clinical trial for its second-generation proteasome inhibitor

Millennium: The Takeda Oncology Company today announced it has further expanded its protein homeostasis program with the initiation of a Phase I clinical trial for an oral formulation of MLN9708, the Company’s second-generation proteasome inhibitor. An intravenous formulation of MLN9708 entered clinical trials in March.

18 Nov 2009

Lee's Pharmaceutical granted exclusive license to Jennerex' lead product for HCC

Jennerex, Inc., a clinical-stage biotherapeutics company developing a proprietary breakthrough class of targeted oncolytic virus therapeutics, today announced in conjunction with Lee's Pharmaceutical Holdings, the execution of a collaboration and license agreement for Jennerex's lead product candidate, JX-594, in certain Asian territories.

18 Nov 2009

CytRx plans Phase 2 clinical trial of its doxorubicin prodrug for advanced gastric cancer

CytRx Corporation, a biopharmaceutical company, today announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.

18 Nov 2009

Epiphany Biosciences announces results from its valomaciclovir Phase 2b trial for shingles

Epiphany Biosciences announced results from its Phase 2b dose-ranging study of EPB-348 (valomaciclovir) in patients with shingles (herpes zoster) infection. The study's primary endpoint was non-inferiority of once-daily valomaciclovir compared to thrice-daily valacyclovir in terms of time to complete crusting of the shingles rash.

18 Nov 2009

Data on Synta Pharmaceuticals' STA-9090 synthetic inhibitor of Hsp90 presented

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that preclinical data presented at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics shows that STA-9090, a novel, synthetic inhibitor of heat shock protein 90 (Hsp90), demonstrated strong activity in multiple tumor models.

18 Nov 2009

Recent data from CNSBio's Phase IIa CNSB015 trial to be presented at the Neuropathic Pain conference

CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA.

18 Nov 2009

Clinical Data commences patient enrollment in Stedivaze Phase III trial

Clinical Data, Inc. today announced that it has enrolled the first patient in its initial Phase III trial of Stedivaze™, a potential best-in-class vasodilator for use in cardiac stress testing. The study will evaluate the safety and efficacy of Stedivaze (apadenoson) for use as a pharmacologic stress agent in myocardial perfusion imaging (MPI), a method for detecting defects in the blood supply to the heart.

18 Nov 2009

New pre-clinical data from Alnylam Pharmaceuticals' ALN-VSP program presented

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, today announced new pre-clinical data from its ALN-VSP program presented at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics International conference being held November 15 - 19, 2009 in Boston, Mass.

18 Nov 2009

Positive results from REVIVE, a phase 3 pivotal study of avanafil announced

VIVUS, Inc. today announced positive results from REVIVE (TA-301), a phase 3 pivotal study evaluating the safety and efficacy of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED), in 646 patients.

18 Nov 2009

Phase 2/3 study results of Genzyme's APB announced

Genzyme Corporation today reported results of a phase 2/3 study of its advanced phosphate binder (APB). The trial met its primary endpoint, which was to show that the APB lowered phosphate levels effectively compared to placebo. However, the APB did not show a significant improvement in phosphate lowering compared to Genzyme’s Renvela® (sevelamer carbonate).

18 Nov 2009

Pluristem’s PLX-PAD holds promise for critical limb ischemia

Pluristem Therapeutics Inc. today announced that safety and potential efficacy parameters were demonstrated by the three month follow up data from the first patient ever to receive its placenta derived cell therapy product, PLX-PAD. The patient is participating in a Phase I dose-escalating clinical trial in Europe with PLX-PAD, the company’s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

18 Nov 2009

Findings of Merck's anacetrapib phase IIb study presented at the AHA sessions

In a phase IIb study in 589 patients with primary hypercholesterolemia or mixed hyperlipidemia treated with anacetrapib as monotherapy or co-administered with atorvastatin, there were persistent lipid effects in the higher dose arms in both the monotherapy and co-administration treatment groups eight weeks after stopping active therapy with anacetrapib.

18 Nov 2009

Updated clinical data from Poniard Pharmaceuticals' picoplatin Phase 2 trial announced

Poniard Pharmaceuticals, Inc. today announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC).

18 Nov 2009

NeoPharm presents LE-DT Phase I data at the AACR conference

NeoPharm, Inc. today announced the results of a Phase I clinical trial of Liposome Encapsulated Docetaxel (LE-DT) an active component of Taxotere® at a joint International Conference of the American Association for Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organization for Research and Treatment of Cancer (EORTC) being held in Boston, MA.

18 Nov 2009

Albireo completes A3309 phase 1b study in patients with chronic idiopathic constipation

Albireo today announced the completion of a phase 1b study showing a favorable tolerability and safety profile of A3309 in patients with chronic idiopathic constipation. In addition, the data revealed appropriate efficacy signals in this patient population. A3309 is a first in class compound developed for the treatment of chronic idiopathic constipation and constipation-predominant Irritable Bowel Syndrome (IBS-C).

18 Nov 2009

On-going Phase 2b study conducted by Roche of ITMN-191 modified

InterMune, Inc. today announced that the on-going Phase 2b study conducted by Roche of ITMN-191 (RG7227) combined with standard of care (SOC) PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin) in HCV treatment-naive patients has been modified.

18 Nov 2009

Review of the results of Phase 2b clinical trial on PASCAL announced

ARYx Therapeutics, Inc., a biopharmaceutical company, announced that a review of the results of the Phase 2b clinical trial, PASCAL, testing the efficacy and safety of ARYx’s compound for the treatment of atrial fibrillation, budiodarone, was presented today at the American Heart Association meeting in Orlando, Florida.

18 Nov 2009

Phase 2 clinical trial to test gene therapy treatment for Alzheimer's disease

Mount Sinai School of Medicine is one of 12 sites nationwide participating in the first Phase 2 clinical trial to test gene therapy treatment for Alzheimer's disease. The study is the first multicenter neurosurgical intervention in Alzheimer's research in the U.S.

18 Nov 2009

Phase III randomized clinical trial for Alpharadin to be commenced

International prostate cancer expert Dr. Oliver Sartor of Tulane Cancer Center is the first oncologist in the United States to offer patients an experimental new treatment for late-stage prostate cancer through a multi-center clinical trial that is currently recruiting patients at 100 sites across 20 countries worldwide.

18 Nov 2009

Ongoing Phase 1 study results of XMT-1001 announced by Mersana Therapeutics

Mersana Therapeutics, a platform-based cancer therapeutics company, announced today additional preliminary results from an ongoing Phase 1 study of its lead development candidate, XMT-1001, in patients with advanced solid tumors.

18 Nov 2009