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Initiation of Phase I/IIa clinical trial of IL-7 announced

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the initiation of a Phase I/IIa clinical trial of IL-7 in support of tumor lysate/KLH pulsed dendritic cell vaccines in a pilot study of tumor vaccination in patients with metastatic or recurrent pediatric solid tumors and altered T cell homeostasis, including patients with Ewing’s sarcoma family of tumors (ESFT), rhabdomyosarcoma, neuroblastoma, synovial cell sarcoma, desmoplastic small round cell tumor, undifferentiated sarcoma, and embryonal sarcoma.

23 Nov 2009

POZEN commences enrollment in PA32540 phase 3 study

POZEN Inc. announced today the start of enrollment for the phase 3 studies for PA32540. PA32540 is a fixed-dose combination of 325 mg of enteric coated aspirin and 40 mg of immediate release omeprazole, under investigation for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers.

20 Nov 2009

Genta announces preliminary results from study of Genasense Injection for advanced melanoma

Genta Incorporated announced preliminary results that show a high objective response rate in a pilot study of patients with advanced melanoma that incorporates the Company’s lead oncology product, Genasense® (oblimersen sodium) Injection, administered for the first time as a 1-hour high-dose intravenous (IV) infusion.

20 Nov 2009

EMEA's CHMP recommends approval of Merck's ELONVA

Merck & Co., Inc. today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVA® (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program.

20 Nov 2009

Inovio Biomedical announces positive test results of its consensus influenza vaccines

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today that a combination of its synthetic consensus H1N1, H2N2, H3N2, and H5N1 influenza vaccine candidates achieved protective antibody responses against several different influenza sub-types and strains in ferrets.

20 Nov 2009

Positive results from recently completed phase II clinical study of ToleroMune therapy announced

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced positive results from a recently completed phase II clinical study of its ToleroMune(R) cat allergy therapy, which successfully identified the optimal dosing regimens to progress into late-stage development.

20 Nov 2009

Data from second positive pivotal study of PSD502 for treatment of PE presented

At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC ("Plethora")., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE).

20 Nov 2009

Curemark begins enrolling patients in Phase III clinical trials for CM-AT

Curemark LLC, (www.curemark.com), a drug research and development company focused on the treatment of neurological diseases, announced that the company has begun enrolling patients in Phase III clinical trials for CM-AT, its autism treatment, at three additional clinical trial sites.

20 Nov 2009

Aegera Therapeutics commences AEG35156 Phase 2B study for AML

Aegera Therapeutics Inc. announced today the dosing of the first patient in a randomized Phase 2B study of AEG35156, a targeted antisense therapeutic in mid-stage development for multiple oncology indications.

19 Nov 2009

Adamas Pharmaceuticals expands its Phase 2 TCAD therapy study for influenza A

Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has expanded its Phase 2 clinical study of a proprietary investigational triple-combination antiviral drug therapy for influenza to include centers in the United States, Canada and Europe. The study, which was initiated in August 2009 in the Southern Hemisphere, is designed to investigate Adamas' triple combination antiviral drug (TCAD) therapy as a treatment for influenza A, including novel influenza A/H1N1, the cause of the current flu pandemic.

19 Nov 2009

Altair Therapeutics initiates its IL-4 receptor alpha inhibitor bronchoprovocation phase 2 trial

Altair Therapeutics, Inc., a privately-held, biopharmaceutical company developing novel therapeutics for respiratory diseases, today announced the commencement of its IL-4 receptor alpha inhibitor bronchoprovocation trial. Study AIR645-CS2 is a phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of inhaled AIR645 in suppressing the asthmatic response in subjects with mild asthma. Results are expected in the third quarter of 2010.

19 Nov 2009

Positive results from Sciele Pharma's second pivotal study of PSD502 for the treatment of PE

At the annual meeting of the Sexual Medicine Society of North America, Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company, and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC, today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE).

19 Nov 2009

Interim data from Geron's ongoing imetelstat trial presented at the AACR-NCI-EORTC conference

Geron Corporation today announced the presentation of interim data from its ongoing trial of imetelstat (GRN163L), a telomerase inhibitor drug, in patients with refractory, advanced solid cancers at the 2009 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

19 Nov 2009

AFFiRiS to commence Phase II trial of its Alzheimer's vaccine candidate

AFFiRiS AG will focus its Alzheimer's vaccine program on one product candidate at an unexpectedly early stage of development: the vaccine candidate AD02 is planned to enter into Phase II clinical trial early in 2010. This decision by the company immediately follows the completion of two Phase I trials with the candidates AD01 and AD02. The company based its fast decision on the first interim analysis of the secondary endpoints at the six month time point.

19 Nov 2009

Final results from ImmuPharma's Phase IIb trial of LUPUZOR

ImmuPharma PLC the specialist discovery and development pharmaceutical company is pleased to announce today the final results from a Phase IIb trial of LUPUZOR™ in active patients with Systemic Lupus Erythematosus (SLE). Lupuzor™ administered at 200 mcg once-a-month for 3 months plus standard of care achieved a clinically significant improvement in patient response rate as measured by the combined score compared to placebo plus standard of care.

19 Nov 2009

Data from Phase 1 safety study of SB-728-T announced

Sangamo BioSciences, Inc. announced today that data from the University of Pennsylvania investigator sponsored Phase 1 safety study of Sangamo's zinc finger nuclease (ZFN) based product, SB-728-T, for HIV/AIDS were inadvertently and prematurely disclosed on the internet.

19 Nov 2009

Results from Phase IIa clinical trial evaluating VT-111 reported by Viron Therapeutics

Viron Therapeutics Inc., a biotechnology company pioneering the development of immune-modulating protein therapeutics derived from pathogens, today reported results from a Phase IIa clinical trial evaluating VT-111 (Serp-1), an anti-inflammatory protein derived from the myxoma virus.

19 Nov 2009

Once-a-day dosing clinical study of udenafil for erectile dysfunction completed

Dong-A Pharmaceutical Co., Ltd. and Dong-A PharmTech, Co. Ltd. announced today that it has completed a 240 patient once-a-day dosing clinical study of udenafil, its new long acting phosphodiesterase type 5 (PDE-5) inhibitor for erectile dysfunction (ED).

19 Nov 2009

Interim data from an ongoing phase 1 dose-escalation trial of XL147 reported

Exelixis, Inc. today reported interim data from an ongoing phase 1 dose-escalation trial of XL147 (SAR245408) in combination with the EGFR inhibitor erlotinib in patients with advanced solid tumors.

19 Nov 2009

Key findings from AstraZeneca's phase II studies of ticagrelor

AstraZeneca today announced the results of the phase II studies, ONSET/OFFSET and RESPOND for ticagrelor (BRILINTA(TM)) at the annual American Heart Association (AHA) Scientific Sessions in Orlando, FL,with ONSET/OFFSET study results being simultaneously published in the medical journal Circulation.

18 Nov 2009