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Alnylam files CTA with the U.K. MHRA to initiate ALN-TTR02 Phase I trial in ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has filed a Clinical Trial Application (CTA) with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase I clinical trial with ALN-TTR02, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis.

7 Jan 2012

Positive topline results from Civitas' CVT-301 Phase 1 trial on PD

Civitas Therapeutics, Inc., a privately-held pharmaceutical company developing transformative therapeutics using the ARCUS(TM) respiratory delivery platform, announced today positive topline results from a Phase 1 clinical trial for CVT-301, an inhaled formulation of levodopa (L-dopa) for the rapid relief from motor fluctuations associated with Parkinson's disease.

7 Jan 2012

KAI commences enrollment in KAI-4169 second Phase 2 study for CKD-MBD

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced initiation of patient enrollment in the second Phase 2 study of KAI-4169, a novel pharmaceutical agent being tested for the treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD) in hemodialysis patients with secondary hyperparathyroidism (SHPT), which is a frequent and serious complication of end-stage renal disease.

6 Jan 2012

Non-eosinophilic disease more prevalent in patients with mild-to-moderate asthma

A large percentage of patients with mild-to-moderate asthma have persistently non-eosinophilic disease which may not respond to currently available anti-inflammatory treatments, according to a new study.

6 Jan 2012

Varenicline may reduce smoking rates before people try to quit

Smokers planning to kick the habit may have more success if they begin using a cessation medication several weeks before they actually try to quit.

6 Jan 2012

Isis announces results from ISIS-TTRRx Phase 1 study on TTR amyloidosis

Isis Pharmaceuticals, Inc. announced today results from a Phase 1 study with ISIS-TTRRx. The results demonstrated that treatment with ISIS-TTRRx produced dose-dependent statistically significant reductions of greater than 80 percent in transthyretin (TTR) protein.

6 Jan 2012

Wake Forest Baptist participates in novel brain tumor vaccine clinical trial

A national clinical trial testing the efficacy of a novel brain tumor vaccine has begun at Wake Forest Baptist Medical Center, the only facility in the Southeast to participate.

6 Jan 2012

Pfizer commences PF-05280602 Phase 1 trial in hemophilia A & B

Catalyst Biosciences, Inc., the leading company in the discovery and development of engineered proteases, today announced that Pfizer Inc. has initiated a Phase 1 clinical trial for PF-05280602, an investigational proprietary, engineered variant of recombinant human Factor VIIa developed by Catalyst Biosciences.

6 Jan 2012

AstraZeneca plans to progress Targacept's AZD1446 as treatment for AD

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced that AstraZeneca has informed the company that it plans to progress the development of Targacept's product candidate AZD1446 as a treatment for Alzheimer's disease.

5 Jan 2012

Baxter commences BAX 855 Phase I trial in hemophilia A

Baxter International Inc. today announced the dosing of the first patients in a Phase I clinical trial of its lead investigational candidate, BAX 855, a longer-acting (PEGylated) form of a full-length recombinant factor VIII (rFVIII) protein.

From Baxter International Inc. 5 Jan 2012

RegeneRx's RGN-259 safe, well tolerated in patients with dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. announced today that it has received the clinical study report for its recently completed Phase 2 clinical trial evaluating RGN-259 for the treatment of dry eye syndrome.

5 Jan 2012

Hepatitis C vaccine succeeds in an early phase clinical trial

An early phase clinical trial of a hepatitis C vaccine has shown promising results, according to researchers at Oxford University. The virus causing Hepatitis C is a difficult one since it changes its appearance, making creation of a vaccine against it a challenge.

5 Jan 2012

Positive results from ProFibrix Phase II Fibrocaps clinical trial

ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that its U.S. multicenter Phase II clinical trial with Fibrocaps in spinal, peripheral vascular and general surgery resulted in a highly statistically significant reduction in mean time to hemostasis (TTH) and incidence of hemostasis at 3, 5 and 10 minutes, as compared to active control.

5 Jan 2012

Probiodrug secures EUR 15M for clinical development of PQ912

Probiodrug AG today announced it has secured EUR 15 million additional financing for the ongoing development of its glutaminyl cyclase (QC) inhibitor program. The lead compound, PQ912, its first QC inhibitor, is in clinical development for the treatment of Alzheimer's disease.

5 Jan 2012

Daily doses of S-equol reduce hot flashes in postmenopausal women

Daily doses of a soy germ-based nutritional supplement containing S-equol significantly improved menopausal symptoms, including significantly reducing hot flash frequency after 12 weeks according to a placebo-controlled study in postmenopausal Japanese women published in the peer-reviewed Journal of Women's Health.

5 Jan 2012

Celldex begins rindopepimut and Avastin Phase 2 combination trial in EGFRvIII-positive GB

Celldex Therapeutics, Inc. today announced that patient screening has initiated in a Phase 2 trial of rindopepimut in combination with Avastin in patients with recurrent epidermal growth factor variant III (EGFRvIII)-positive glioblastoma, called the "ReACT Study."

5 Jan 2012

Bionomics, Ironwood partner to develop and commercialize novel anti-anxiety compound

Ironwood Pharmaceuticals, Inc. and Bionomics Limited today announced that they entered into a collaboration, research, and licensing agreement that will enable Ironwood to develop and commercialize Bionomics' investigational anti-anxiety compound BNC210 and other related compounds.

5 Jan 2012

Positive results from Alkermes ALKS 5461 phase 1/2 study on MDD

Alkermes plc today announced positive topline results from a phase 1/2 study of ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression.

5 Jan 2012

Investigational HSV vaccine shows promise against two genital herpes diseases

An investigational vaccine protected some women against infection from one of the two types of herpes simplex viruses that cause genital herpes, according to findings in the New England Journal of Medicine.

5 Jan 2012

Positive preliminary results from Alnylam's Phase I ALN-PCS trial on severe hypercholesterolemia

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today the achievement of positive preliminary results from its ongoing clinical trial of ALN-PCS, an RNAi therapeutic targeting PCSK9 for the treatment of severe hypercholesterolemia.

5 Jan 2012