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Enzymerx completes enrollment for clinical trial of pegsitacase

EnzymeRx, LLC, a clinical-stage biotechnology company, announced completion of the enrollment of its first clinical trial of pegsitacase (formerly called Uricase-PEG 20), and the recent launch of a second clinical study. Pegsitacase is a pegylated uricase being developed by EnzymeRx for the treatment of refractory gout and for the management of hyperuricemia associated with tumor lysis syndrome.

22 Feb 2010

FDA grants Fast Track designation for Curemark's CM-AT autism treatment

Curemark LLC, a drug research and development company focused on the treatment of neurological diseases, announced that its CM-AT autism treatment, now in Phase III clinical trials, has been designated as a Fast Track drug by the U.S. Food and Drug Administration (FDA).

22 Feb 2010

Alnylam Pharmaceuticals initiates ALN-RSV01 Phase IIb trial in adult lung transplant patients for RSV infection

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has initiated a Phase IIb trial in adult lung transplant patients with ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV) infection. RSV infection in lung transplant patients represents an important unmet medical need; the condition is associated with significant morbidity, including the development of acute lung transplant rejection in 10% to 20% of infected patients.

22 Feb 2010

Emory School of Medicine to enroll nearly 1,140 people for Phase III clinical trial of progesterone for TBI

Researchers at 17 medical centers across the country soon will begin using the hormone progesterone to treat patients who experience traumatic brain injury (TBI). The treatment is part of a randomized, double-blind Phase III clinical trial that will enroll approximately 1,140 people over a three- to six-year period beginning in March, 2010. The trial is funded by a grant to Emory University from the National Institutes of Health.

20 Feb 2010

Polyphor discovers new class of antibiotics effective against multi-drug resistant Gram-negative bacteria

Today, Polyphor Ltd published the discovery of a new class of antibiotics with a novel mode of action (Science, VOL 327, ISSUE 5968). This proprietary new class of antibiotics is effective against multi-drug resistant Gram-negative bacteria, opening up new treatment options for serious and often life-threatening infections. The most advanced drug candidate in this new class, POL7080, selectively kills the dangerous bacteria Pseudomonas aeruginosa.

19 Feb 2010

BioCrossroads' Indiana Seed Fund invests $400,000 in Bioscience Vaccines

BioCrossroads' Indiana Seed Fund has invested in Bioscience Vaccines, Inc. to accelerate the development of biologic materials, which may boost the effectiveness of a wide range of life-saving vaccines.

19 Feb 2010

Data from Novavax's Pivotal 2009 A/H1N1 VLP pandemic influenza vaccine study presented at WHO meeting

Novavax, Inc. today presented to the world's leading pandemic influenza vaccine experts a summary of the recent preliminary safety and immunogenicity data from its Pivotal 2009 A/H1N1 VLP pandemic influenza vaccine study in Mexico.

19 Feb 2010

BioSante Pharmaceuticals' LibiGel clinical update to be presented at 2010 ISSWSH annual meeting

BioSante Pharmaceuticals, Inc., will present a LibiGel clinical update at the 2010 Annual Meeting of the International Society for the Study of Women’s Sexual Health (ISSWSH), being held from February 18-20, 2010 in St. Petersburg, Florida.

19 Feb 2010

Incyte announces 2009 financial results and key fourth-quarter accomplishments

Incyte Corporation today reported fourth quarter and full year 2009 financial results, provided an update on key fourth quarter accomplishments and 2010 objectives, and announced its 2010 financial guidance.

18 Feb 2010

Phase 2 study results: VEGF Trap-Eye improves vision in patients with DME

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare AG announced that VEGF Trap-Eye showed positive results in a Phase 2 study in patients with diabetic macular edema (DME).

18 Feb 2010

PK/PD data demonstrates clear relationship between TBR-652 plasma concentrations and antiviral activity

Pharmacokinetic/pharmacodynamic (PK/PD) data for TBR-652, which is being developed by Tobira Therapeutics for the treatment of HIV infection, show a strong relationship between drug exposure and viral suppression with this next-generation CCR5 receptor antagonist. These data were presented here today at the 17th Conference on Retroviruses and Opportunistic Infections (CROI).

18 Feb 2010

Aprea's AML treatment receives EMEA recommendation for orphan drug status

The European Medicines Agency (EMEA) recommends orphan drug status for Aprea's treatment of acute myeloid leukemia (AML). The treatment is currently undergoing a Phase I clinical study and a final decision from the European Commission regarding status is expected in a few weeks. Aprea is part of the Karolinska Development portfolio.

18 Feb 2010

Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Gilead Sciences, Inc. announced Phase II clinical trial results today showing that its investigational fixed-dose single-tablet “Quad” regimen of elvitegravir, GS 9350 (cobicistat) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection exhibited antiretroviral activity comparable to that of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

18 Feb 2010

Phase III data reveals potential of Merck’s GARDASIL in preventing HPV and HPV-related cancers

Merck & Co., Inc. announced today that in new Phase III data, GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] was 77.5 percent (95 percent CI: 39.6, 93.3) efficacious against anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men. The data were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) conference in Monte Carlo, Monaco.

18 Feb 2010

Phase 3b ODIN study of once-daily PREZISTA in HIV-1 adults presented at CROI 2010

In a new study of treatment-experienced HIV-1-infected adults with no PREZISTA® (darunavir) resistance-associated mutations (RAMs), 72 percent of patients in the PREZISTA/ritonavir (r) (800/100 mg) once-daily arm achieved undetectable viral loads (<50 copies/mL) compared with 71 percent of patients in the PREZISTA/r (600/100 mg) twice-daily arm. The study met its primary objective of non-inferiority. These data from the Phase 3b ODIN study were presented today at CROI 2010, the 17th Conference on Retroviruses and Opportunistic Infections, in San Francisco.

18 Feb 2010

Roche completes enrollment in RG7128 Phase 2b PROPEL study

Pharmasset, Inc. announced today the complete enrollment by Roche of the 12 week RG7128 Phase 2b study (PROPEL) of approximately 400 treatment-naive patients with hepatitis C virus (HCV) genotypes 1 and 4. The study remains blinded to Roche and Pharmasset.

17 Feb 2010

Tioga Pharmaceuticals to utilize $18M equity funding for Phase 3 clinical trial of asimadoline

Tioga Pharmaceuticals, Inc. today announced the closing of an $18 million equity financing. Current investors Forward Ventures, New Leaf Venture Partners and BB Biotech Ventures were joined by new investor Genesys Capital Partners.

17 Feb 2010

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Otonomy, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of OTO-104 in patients with Meniere's disease, a debilitating disorder of the inner ear affecting balance and hearing.

17 Feb 2010

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

Marcadia Biotech Inc. today announced that it has initiated a Phase 1 clinical trial of MAR701, a novel dual agonist of the incretin hormone receptors for glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP). Marcadia plans to initially develop this compound as a treatment for type 2 diabetes with once-weekly dosing. The Phase 1 trial will evaluate MAR701 in healthy volunteers at escalating dose levels.

17 Feb 2010

Fourth-quarter and full-year 2009 results announced by Celsion

Celsion Corporation, a leading oncology drug development company, today announced financial results for the fourth quarter and year ended December 31, 2009. Management also highlighted the progress made in clinical trials of ThermoDox®, Celsion's heat activated liposomal encapsulation of doxorubicin, including the Company's pivotal Phase III trial for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer, and recurrent chest wall breast cancer.

17 Feb 2010

Drug Trial News

Enzymerx completes enrollment for clinical trial of pegsitacase

FDA grants Fast Track designation for Curemark's CM-AT autism treatment

Alnylam Pharmaceuticals initiates ALN-RSV01 Phase IIb trial in adult lung transplant patients for RSV infection

Emory School of Medicine to enroll nearly 1,140 people for Phase III clinical trial of progesterone for TBI

Polyphor discovers new class of antibiotics effective against multi-drug resistant Gram-negative bacteria

BioCrossroads' Indiana Seed Fund invests $400,000 in Bioscience Vaccines

Data from Novavax's Pivotal 2009 A/H1N1 VLP pandemic influenza vaccine study presented at WHO meeting

BioSante Pharmaceuticals' LibiGel clinical update to be presented at 2010 ISSWSH annual meeting

Incyte announces 2009 financial results and key fourth-quarter accomplishments

Phase 2 study results: VEGF Trap-Eye improves vision in patients with DME

PK/PD data demonstrates clear relationship between TBR-652 plasma concentrations and antiviral activity

Aprea's AML treatment receives EMEA recommendation for orphan drug status

Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Phase III data reveals potential of Merck’s GARDASIL in preventing HPV and HPV-related cancers

Phase 3b ODIN study of once-daily PREZISTA in HIV-1 adults presented at CROI 2010

Roche completes enrollment in RG7128 Phase 2b PROPEL study

Tioga Pharmaceuticals to utilize $18M equity funding for Phase 3 clinical trial of asimadoline

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

Fourth-quarter and full-year 2009 results announced by Celsion

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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