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Phase 1 SAD study of PSI-938 for HCV initiated

Pharmasset, Inc. announced today that dosing has initiated in a phase 1, single ascending dose study in healthy volunteers with PSI-938, a third generation purine nucleotide analog polymerase inhibitor of hepatitis C virus. Pharmasset recently filed an Investigational New Drug Application with the Food and Drug Administration.

8 Apr 2010

OncoGenex Pharmaceuticals recognized with BIOTECanada's Gold Leaf Award

OncoGenex Pharmaceuticals, Inc. announced today that the Company will be presented with BIOTECanada's Gold Leaf Award as biotech company of the year. The award recognizes a biotech company that has distinguished itself from its peers with strong overall performance as a company, demonstrated leadership and shown significant achievement.

8 Apr 2010

Enrollment completes for Inovio Biomedical's dose escalation phase I trial of cervical cancer vaccine

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today that the company has completed enrollment of all subjects for its therapeutic cervical cancer vaccine (VGX-3100) phase I trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18, and is delivered via in vivo electroporation.

8 Apr 2010

Telaprevir-based regimens increase rates of SVR in patients with genotype 1 HCV infection

In a clinical trial known as PROVE 3 published in this week's New England Journal of Medicine, treatment with telaprevir-based regimens significantly increased rates of sustained viral response (SVR) in patients with genotype 1 hepatitis C virus (HCV) infection who did not achieve SVR with at least one prior course of pegylated-interferon and ribavirin therapy.

8 Apr 2010

Phase III trial of brentuximab vedotin for post-transplant Hodgkin lymphoma initiated

Seattle Genetics, Inc., Takeda Pharmaceutical Company Limited and its wholly owned subsidiary Millennium: The Takeda Oncology Company today announced the initiation of a phase III clinical trial of brentuximab vedotin (SGN-35) for post-transplant Hodgkin lymphoma patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, which is expressed on malignant Hodgkin lymphoma cells.

8 Apr 2010

Results of M118 EMINENCE clinical trial published in Circulation

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex mixture drugs, today announced that the results of the M118 EMINENCE clinical trial have published in Circulation.

8 Apr 2010

Phase II clinical trial of Avastin and Tarceva in patients with glioblastoma multiforme

Patients suffering from recently diagnosed malignant brain tumors called glioblastoma multiforme or a rare variant called gliosarcoma may be eligible to participate in a Phase II clinical trial at Cedars-Sinai Medical Center that combines two innovative drugs.

8 Apr 2010

Encouraging results from OptiNose's sumatriptan Phase II study for migraine

OptiNose, a leader in nasal drug delivery systems, is pleased to announce the publication in Cephalalgia of results from its Phase II clinical study investigating the efficacy and tolerability of its novel, intranasal drug/device product for the treatment of migraine.

8 Apr 2010

MAP Pharmaceuticals initiates PD trial comparing LEVADEX to IV DHE

MAP Pharmaceuticals, Inc. today announced that the Company initiated a pharmacodynamics (PD) trial to compare the acute effect of LEVADEX™ orally inhaled migraine therapy to intravenous dihydroergotamine mesylate (IV DHE) and placebo on pulmonary artery pressure as measured by echocardiography.

8 Apr 2010

Avid Radiopharmaceuticals, PETNET Solutions collaborate in manufacture of Florbetapir F 18

Avid Radiopharmaceuticals, Inc. and PETNET Solutions, Inc., a wholly-owned subsidiary of Siemens Medical Solutions, USA, Inc., marked the first dose shipped from a PETNET Solutions manufacturing facility as part of its collaboration with Avid on Florbetapir F 18 (18F-AV-45 or Florbetapir), Avid's molecular imaging agent for positron emission tomography (PET) imaging of β-amyloid deposits in the brain, a key pathological component of Alzheimer's disease.

8 Apr 2010

King Pharmaceuticals commences Phase IIb clinical trial of ELADUR for chronic low back pain

DURECT Corporation announced today that its licensee, King Pharmaceuticals, has begun a Phase IIb clinical trial to evaluate ELADUR™ (TRANSDUR™-Bupivacaine) for the treatment of chronic low back pain. ELADUR is an investigational transdermal drug patch intended to deliver bupivacaine for up to 3 days from a single application.

7 Apr 2010

Calistoga Pharmaceuticals commences CAL-101 trial in combination with Rituxan and/or Treanda

Calistoga Pharmaceuticals, Inc., the leader in the development of isoform-selective phosphatidylinositol 3 kinase (PI3K) inhibitors for the treatment of cancer and inflammatory diseases, today announced the initiation of a Phase 1 trial of CAL-101, the Company's oral, PI3K delta inhibitor, in combination with standard of care agents Rituxan® (rituximab) and/or Treanda® (bendamustine) in patients with relapsed or refractory indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

7 Apr 2010

Cytrx to commence Phase 2 trial of bafetinib for advanced prostate cancer

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced plans to initiate a Phase 2 proof-of-concept clinical trial in the second half of 2010 to evaluate the effectiveness and safety of its oncology drug candidate bafetinib (formerly known as INNO-406) in patients with an advanced form of prostate cancer known as metastatic hormone-refractory prostate cancer.

7 Apr 2010

MAP Pharmaceuticals to present additional data from FREEDOM-301 Phase 3 trial of LEVADEX at AAN meeting

MAP Pharmaceuticals, Inc. today announced the Company will present additional post-hoc analyses from the FREEDOM-301 Phase 3 trial of its investigational LEVADEX™ orally inhaled migraine therapy in two patient subpopulations that are often difficult to treat with current triptan migraine therapies: menstrual migraine and migraine with allodynia.

7 Apr 2010

Nile Therapeutics to fund ongoing Phase II clinical trial of CD-NP with proposed public offering

Nile Therapeutics, Inc., a company focused on the development of novel therapeutics for heart failure patients, announced today that it intends to offer units consisting of shares of its common stock and warrants to purchase shares of its common stock in a public offering. Maxim Group LLC is acting as the sole book-running manager for this offering, with Ladenburg Thalmann & Co. Ltd. as co-manager.

7 Apr 2010

Nationwide Phase III clinical trial of OncoVEX for advanced melanoma

Rush University Medical Center is leading a nationwide Phase III clinical trial to determine whether a promising vaccine for advanced melanoma can effectively treat the deadly skin cancer.

7 Apr 2010

Optimer Pharmaceuticals to present data from fidaxomicin Phase 3 studies at 20th ECCMID

Optimer Pharmaceuticals, Inc. announced that data from the fidaxomicin Phase 3 clinical studies will be presented at the 20th annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna, Austria.

7 Apr 2010

MMRC initiates Phase Ib/II study of Treanda in combination with Revlimid and dexamethasone

The Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a Phase Ib/II study of bendamustine (Treanda®), an anticancer agent currently approved for the treatment of chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin's lymphoma (NHL), in combination with lenalidomide (Revlimid®) and dexamethasone in patients with relapsed multiple myeloma. The trial, led by Shaji Kumar, MD, of Mayo Clinic, is open for enrollment at Mayo Clinic (Rochester, Minn.), City of Hope Cancer Center (Duarte, Calif.) and the University of Chicago (Chicago, Ill).

7 Apr 2010

Three scientific posters featuring Zenvia to be presented at AAN Annual Meeting

AVANIR Pharmaceuticals, Inc., today announced it will present three scientific posters featuring detailed Zenvia™ (dextromethorphan/quinidine) safety and efficacy data from the double-blind phase and the open label extension of the Phase III confirmatory STAR trial at the American Academy of Neurology Annual Meeting in Toronto, Canada, taking place April 10 - 17, 2010.

6 Apr 2010

Keryx Biopharmaceuticals' perifosine receives FDA Fast Track Designation

Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.

5 Apr 2010

Drug Trial News

Phase 1 SAD study of PSI-938 for HCV initiated

OncoGenex Pharmaceuticals recognized with BIOTECanada's Gold Leaf Award

Enrollment completes for Inovio Biomedical's dose escalation phase I trial of cervical cancer vaccine

Telaprevir-based regimens increase rates of SVR in patients with genotype 1 HCV infection

Phase III trial of brentuximab vedotin for post-transplant Hodgkin lymphoma initiated

Results of M118 EMINENCE clinical trial published in Circulation

Phase II clinical trial of Avastin and Tarceva in patients with glioblastoma multiforme

Encouraging results from OptiNose's sumatriptan Phase II study for migraine

MAP Pharmaceuticals initiates PD trial comparing LEVADEX to IV DHE

Avid Radiopharmaceuticals, PETNET Solutions collaborate in manufacture of Florbetapir F 18

King Pharmaceuticals commences Phase IIb clinical trial of ELADUR for chronic low back pain

Calistoga Pharmaceuticals commences CAL-101 trial in combination with Rituxan and/or Treanda

Cytrx to commence Phase 2 trial of bafetinib for advanced prostate cancer

MAP Pharmaceuticals to present additional data from FREEDOM-301 Phase 3 trial of LEVADEX at AAN meeting

Nile Therapeutics to fund ongoing Phase II clinical trial of CD-NP with proposed public offering

Nationwide Phase III clinical trial of OncoVEX for advanced melanoma

Optimer Pharmaceuticals to present data from fidaxomicin Phase 3 studies at 20th ECCMID

MMRC initiates Phase Ib/II study of Treanda in combination with Revlimid and dexamethasone

Three scientific posters featuring Zenvia to be presented at AAN Annual Meeting

Keryx Biopharmaceuticals' perifosine receives FDA Fast Track Designation

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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