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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

SinoFresh Nasal Spray effective against 'swine flu' in animal study

SinoFresh Healthcare Products, Inc. announced today the successful results of its initial pilot animal study testing the efficacy of the SinoFresh Nasal Spray product when used on animals infected with the H1N1 virus. The study data suggests that treatment with SinoFresh allowed the infected animals to recover more rapidly from H1N1 infection than did untreated animals. In addition, pre-treatment with SinoFresh Nasal Spray decreased the severity and/or incidence of infection.

19 Nov 2009

Astellas Pharma and XenoPort submit NDA in Japan for PMDA approval

Astellas Pharma Inc. and XenoPort, Inc. today announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

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

RBM and Covance sign biomarker alliance and services agreement

Rules-Based Medicine, Inc. (RBM) today announced it has entered into a biomarker alliance and services agreement with Covance Inc. that will provide biotechnology and pharmaceutical companies with a powerful combination of biomarker technologies and services for use in drug development. Under terms of the agreement, Covance will use RBM as its exclusive third-party provider of multiplexed protein biomarker testing services, and RBM shall use Covance as its exclusive referral source for laboratory testing services.

19 Nov 2009

New biomarkers can predict patients' response to certain drugs

Recent advances in cancer therapeutics have led to the discovery of biomarkers that can predict patient response to certain drugs. Screening for mutations in the epidermal growth factor receptor (EGRF) prior to non-small cell lung cancer treatment, for example, has been shown to indentify patients who are likely to respond to treatment with erlontinib. This maximizes the drug's impact, and spares patients who are not likely to benefit from being subjected to potentially debilitating side effects.

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

Covance and Rules-Based Medicine enter into biomarker alliance and services agreement

Covance Inc., a leading provider of drug development services, announced today that it entered into a biomarker alliance and services agreement with Rules-Based Medicine, Inc. (RBM), a leading provider of multiplexed protein biomarker testing to the pharmaceutical industry.

19 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

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

Pfizer Canada accepts Prix Galien Canada 2009 Innovative Product Award for CHAMPIX

Pfizer Canada accepted the Prix Galien Canada 2009 Innovative Product Award for CHAMPIX (varenicline tartrate), the first prescription treatment for smoking cessation in adults specifically designed to target nicotine addiction. The award was presented last night at a gala in Ottawa recognizing excellence in pharmaceutical research.

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

SynCon Chikungunya virus DNA vaccine induces protective neutralizing antibody responses in animal model

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today that the company's SynCon™ Chikungunya virus DNA vaccine induced protective neutralizing antibody responses in a preclinical non-human primate model.

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

The Center for Modeling Optimal Outcomes discovers causal path of autism

During its research into the application of neuroscience in business, a New Jersey based think tank, The Center for Modeling Optimal Outcomes®, LLC (The Center) made an inadvertent and amazing discovery.

18 Nov 2009

Cancer-fighting protein successfully placed directly into solid tumors and turned on

Experiments at the Pioneer Valley Life Sciences Institute (PVLSI) at Baystate Medical Center in Springfield, Mass., reported in a recent British Journal of Cancer, confirm that University of Massachusetts Amherst chemical engineer Neil Forbes' delivery and trigger system has for the first time successfully placed TRAIL, a cancer-fighting protein, directly into solid tumors and on cue, turned it on. The treatment improved the 30-day survival time of mice with mammary tumors from 0 to 100 percent.

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

Ambrisentan improves health and exercise capacity of PAH patients, find researchers

In one of the few studies of the long-term effects of medication in the treatment of pulmonary arterial hypertension (PAH) disease, a team of researchers found the health and exercise capacity of PAH patients improved after two years of treatment with ambrisentan, according to a study published in the current edition of the Journal of the American College of Cardiology.

18 Nov 2009

Efficacy News and Research

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

SinoFresh Nasal Spray effective against 'swine flu' in animal study

Astellas Pharma and XenoPort submit NDA in Japan for PMDA approval

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

RBM and Covance sign biomarker alliance and services agreement

New biomarkers can predict patients' response to certain drugs

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

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

Covance and Rules-Based Medicine enter into biomarker alliance and services agreement

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

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

Clinical Data commences patient enrollment in Stedivaze Phase III trial

Pfizer Canada accepts Prix Galien Canada 2009 Innovative Product Award for CHAMPIX

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

SynCon Chikungunya virus DNA vaccine induces protective neutralizing antibody responses in animal model

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

The Center for Modeling Optimal Outcomes discovers causal path of autism

Cancer-fighting protein successfully placed directly into solid tumors and turned on

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

Ambrisentan improves health and exercise capacity of PAH patients, find researchers

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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