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Interim results from Cytheris CYT107 Phase I clinical trial in TCD bone marrow transplant patients

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced interim results from a Phase I clinical trial of its investigational drug candidate, recombinant human Interleukin-7 (CYT107), in the treatment of post-transplant patients with T-cell depleted (TCD) bone marrow or peripheral blood stem cell transplants.

7 Dec 2010

New ways to identify patients most likely to respond to cancer vaccine treatment

A personalized vaccine is a powerful therapy to prevent recurrence among certain follicular lymphoma patients, according to the latest results of ongoing research led by the University of Pennsylvania School of Medicine. The new findings show that when these patients - whose tumors are marked by a specific protein that may be present in up to half of people with this type of cancer -- receive a vaccine made from their own tumor cells, disease-free survival is improved by nearly two years, compared with patients who receive a placebo.

7 Dec 2010

Positive results from PROCHIEVE 8% vaginal progesterone gel Phase III trial to reduce preterm birth risk

Columbia Laboratories, Inc. and Watson Pharmaceuticals, Inc. today announced positive top-line results from the PREGNANT Study, a large, global Phase III clinical trial evaluating PROCHIEVE® 8% vaginal progesterone gel to reduce the risk of preterm birth in women with a short cervical length as measured by transvaginal ultrasound at mid-pregnancy.

7 Dec 2010

Global phase III study to provide novel extended release of topiramate

Data presented yesterday showed that USL255, a novel extended-release (ER) formulation of topiramate, was associated with less fluctuation in topiramate plasma levels than immediate-release (IR) topiramate in healthy volunteers.

7 Dec 2010

No overall cancer risk in people who donate stem cells

American Society of Hematology reveals that there is no increase in overall cancer risk in people who donate stem cells and that the utilization of a double cord blood stem cell transplant is associated with better overall outcomes when used early in the treatment of acute leukemias.

7 Dec 2010

Mayo Clinic scientists say JAK inhibitors may help treat patients with myelofibrosis

Two janus kinase (JAK) inhibitors are substantially improving treatment of myelofibrosis in patients, say Mayo Clinic researchers who are presenting results of several clinical trials at the 52nd annual meeting of the American Society of Hematology (ASH) Dec. 4 in Orlando.

7 Dec 2010

Clinical trial results of ACY-1215 in multiple myeloma published in scientific journal of ASH

Acetylon Pharmaceuticals today announced the publication of favorable results of preclinical safety and efficacy testing of its oral selective HDAC6 inhibitor drug candidate, ACY-1215, in multiple myeloma.

7 Dec 2010

New drug appears to help patients with chronic myeloid leukemia

A new drug appears to help chronic myeloid leukemia patients who are out of treatment options after first- and second-line drugs have failed them or because their cancer cells have a mutation that makes them resistant from the start, researchers reported at the 52nd Annual Meeting of the American Society of Hematology.

7 Dec 2010

Boceprevir drug may cure hepatitis C

The outlook for patients with hepatitis C continues to improve as results from a clinical trial led by a Saint Louis University researcher found that the drug boceprevir helped cure hard-to-treat patients. The findings were reported at the 61st annual meeting of the American Association for the Study of Liver Disease's earlier in November.

7 Dec 2010

FDA accepts for review Bristol-Myers Squibb's ORENCIA sBLA for severe RA

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the subcutaneous formulation of ORENCIA® (abatacept), a treatment for adult patients with moderate to severe rheumatoid arthritis (RA) administered through an injection into the skin. Bristol-Myers Squibb submitted the sBLA to the FDA for the subcutaneous formulation of ORENCIA and received confirmation of its receipt on October 4, 2010.

7 Dec 2010

GeoVax expands Phase 2a clinical trial for MVA62B HIV/AIDS vaccine

GeoVax Labs, Inc., announced today the expansion of the Phase 2a clinical trial testing of its HIV/AIDS vaccine products. The expanded Phase 2a trial will test the administration of three doses of the recombinant poxvirus vaccine MVA62B without the use of the recombinant DNA-vectored vaccine, which was used to prime immune responses in the first part of this trial.

7 Dec 2010

ArQule initiates enrollment in ARQ 736 Phase 1 clinical trial for advanced solid tumors

ArQule, Inc. today announced the commencement of patient dosing in a Phase 1 clinical trial with ARQ 736, a small molecule inhibitor of the RAF kinases.

7 Dec 2010

Achillion Pharmaceuticals to present clinical study data of ACH-1625 at APASL 2011

Achillion Pharmaceuticals, Inc. today announced that data from the Company's ongoing clinical studies of ACH-1625 has been accepted for presentation at the 21st Annual Conference of the Asian Pacific Association for the Study of the Liver to be held February 17-21, 2011 in Bangkok, Thailand.

6 Dec 2010

PAREXEL International opens two new Clinical Logistics Services facilities

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced that it has opened two new Clinical Logistics Services facilities in emerging regions for biopharmaceutical development. PAREXEL's new depot in Singapore and ancillary warehouse in Russia will support its clients in more effectively managing their global clinical trial supply requirements.

From Parexel 6 Dec 2010

Preclinical data of ZIO-101 in various lymphoma models presented at ASH 2010

ZIOPHARM Oncology, Inc. announced today that new preclinical data on the novel mechanism of its organic arsenic darinaparsin (ZIO-101) in various lymphoma models were presented at the 52nd Annual Meeting and Exposition of the American Society of Hematology in Orlando Florida.

6 Dec 2010

Fraunhofer USA CMB receives FDA approval to initiate Phase I clinical trial of H5N1 influenza vaccine

Fraunhofer USA Center for Molecular Biotechnology announced today it has received approval from the Food and Drug Administration to proceed with the first human clinical trial of plant-produced H5N1 influenza vaccine.

6 Dec 2010

NovaBay Pharmaceuticals, Galderma expand their multi-year collaboration agreement

NovaBay Pharmaceuticals, Inc., a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, and Galderma, a global leading pharmaceutical company dedicated exclusively to the field of dermatology, announce the expansion of their multi-year collaboration agreement. Based on positive data assessing the activity of NovaBay's Aganocide compounds against impetigo, Galderma has agreed to exercise its option for this indication.

6 Dec 2010

Phase 1 clinical data: ARRY-520 shows positive preliminary results in treating multiple myeloma

Array BioPharma Inc. today announced the presentation of positive Phase 1 clinical data for its novel kinesin spindle protein inhibitor, ARRY-520. The data, which were presented at the 2010 Annual Meeting of the American Society of Hematology in Orlando, Florida, indicate that ARRY-520 was well tolerated and has shown encouraging preliminary results in the treatment of multiple myeloma.

6 Dec 2010

Research on BCR-ABL inhibitors for treating ALL, CML presented at ASH Annual Meeting

Over the past decade, significant advances have been made in the treatment of leukemia through the ongoing development of gene-based targeted therapies. Research that will be presented today at the 52nd Annual Meeting of the American Society of Hematology provides greater understanding of the optimal use of several BCR-ABL inhibitors for the treatment of acute lymphoblastic leukemia and chronic myeloid leukemia, and how a new gene target functions for several myeloid malignancies.

6 Dec 2010

First patient dosed with rFVIIIFc in A-LONG trial

Biogen Idec and Swedish Orphan Biovitrum today announced that the first patient has been dosed with the companies' long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc) in a global registrational clinical trial. The study, called A-LONG, is an open-label, multicenter, Phase 2/3 study designed to evaluate the safety, pharmacokinetics and efficacy of rFVIIIFc in previously-treated hemophilia A patients.

6 Dec 2010

Clinical Trial News and Research

Interim results from Cytheris CYT107 Phase I clinical trial in TCD bone marrow transplant patients

New ways to identify patients most likely to respond to cancer vaccine treatment

Positive results from PROCHIEVE 8% vaginal progesterone gel Phase III trial to reduce preterm birth risk

Global phase III study to provide novel extended release of topiramate

No overall cancer risk in people who donate stem cells

Mayo Clinic scientists say JAK inhibitors may help treat patients with myelofibrosis

Clinical trial results of ACY-1215 in multiple myeloma published in scientific journal of ASH

New drug appears to help patients with chronic myeloid leukemia

Boceprevir drug may cure hepatitis C

FDA accepts for review Bristol-Myers Squibb's ORENCIA sBLA for severe RA

GeoVax expands Phase 2a clinical trial for MVA62B HIV/AIDS vaccine

ArQule initiates enrollment in ARQ 736 Phase 1 clinical trial for advanced solid tumors

Achillion Pharmaceuticals to present clinical study data of ACH-1625 at APASL 2011

PAREXEL International opens two new Clinical Logistics Services facilities

Preclinical data of ZIO-101 in various lymphoma models presented at ASH 2010

Fraunhofer USA CMB receives FDA approval to initiate Phase I clinical trial of H5N1 influenza vaccine

NovaBay Pharmaceuticals, Galderma expand their multi-year collaboration agreement

Phase 1 clinical data: ARRY-520 shows positive preliminary results in treating multiple myeloma

Research on BCR-ABL inhibitors for treating ALL, CML presented at ASH Annual Meeting

First patient dosed with rFVIIIFc in A-LONG trial

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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