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Riley Hospital for Children commences patient enrollment in clinical trial of cystic fibrosis drug

The Riley Hospital for Children Cystic Fibrosis Center is the first site in the nation to enroll patients ages 6-11 for the first part of a 48-week clinical trial of a promising investigational treatment for cystic fibrosis (CF).

9 Oct 2009

Additional Zenvia Phase III results in multiple sclerosis announced by AVANIR

AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced additional detailed results from the confirmatory double-blind Phase III STAR trial evaluating two doses of the investigational drug Zenvia™ (dextromethorphan/quinidine) compared to placebo in the treatment of pseudobulbar affect (PBA) among patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS). Over the course of the 12-week study in the MS patient subset, Zenvia 30/10 mg met the primary efficacy endpoint by reducing PBA episode rates by an incremental 11.9% beyond placebo

9 Oct 2009

Plexxikon commences patient dosing in PLX3397 Phase 1 clinical trial

Plexxikon Inc. today announced that dosing of cancer patients with PLX3397 has started in a Phase 1 clinical trial. PLX3397 is a novel, oral investigational drug for treating multiple diseases, including metastatic cancer and rheumatoid arthritis.

9 Oct 2009

Lpath reports positive Phase 1 clinical trial results of iSONEP in wet-AMD patients

Lpath, Inc., the category leader in lipidomics-based therapeutics, reported positive summary results of its single-dose Phase 1 clinical trial of iSONEP™ in wet-AMD patients.

8 Oct 2009

Keryx Biopharmaceuticals commences Phase 2 clinical study evaluating KRX-0401 for Chronic Lymphocytic Leukemia

Keryx Biopharmaceuticals, Inc. announced today the initiation of a Phase 2 clinical study to evaluate KRX-0401 (perifosine) as a single agent treatment for relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL).

8 Oct 2009

Paratek Pharmaceuticals and Novartis to collaborate in PTK 0796 broad-spectrum antibiotic development

Paratek Pharmaceuticals, Inc. announced today that it has entered into an exclusive worldwide collaborative development, manufacturing and commercialization license agreement with Novartis for Paratek's lead broad-spectrum antibiotic, PTK 0796, a first-in-class aminomethylcycline (AMC) in Phase 3 clinical trials.

8 Oct 2009

Macuclear and Mystic announce groundbreaking results from Phase Ib Clinical Trial for Macular Degeneration

MacuCLEAR, Inc. and Mystic Pharmaceuticals, Inc., announced today preliminary successful results of a Phase Ib Clinical Trial for the treatment and prevention of the progression of Age Related Macular Degeneration (AMD). The preliminary results indicated that MacuCLEAR’s MC-1101 drug is safe and well tolerated by study participants, and has a biological effect on blood flow in the back of the retina.

8 Oct 2009

Relypsa commences patient enrollment in Phase 2b clinical trial of RLY5016 for treating hyperkalemia

Relypsa, Inc., today announced the initiation of patient enrollment in the PEARL-HF study, a Phase 2b clinical trial of the company’s lead compound, RLY5016. A novel potassium binder designed for chronic use, RLY5016 is being evaluated in the prevention and treatment of hyperkalemia, for which there are no current satisfactory treatments.

7 Oct 2009

Cipher Pharmaceuticals enrolls first patient in Phase III study of CIP-ISOTRETINOIN

Cipher Pharmaceuticals Inc. today announced that it has enrolled the first patient in its Phase III safety study of CIP-ISOTRETINOIN, the Company's novel, patented formulation of isotretinoin, which is used in the treatment of severe, nodular acne.

7 Oct 2009

Zelos Therapeutics commences patient dosing of ZT-034 for treating osteoporosis

Zelos Therapeutics, Inc. has initiated patient dosing in a single dose study of three proprietary subcutaneous formulations of ZT-034 (hPTH (1-34), teriparatide). ZT-034 is being developed to compete with Eli Lilly and Company’s Forteo (teriparatide [rDNA origin]) in its existing market of approximately $800M in annual sales in 2008 for the treatment of osteoporosis.

7 Oct 2009

Idera Pharmaceuticals commences phase 1 IMO-2125 clinical trial for chronic HCV infection

Idera Pharmaceuticals, Inc. today announced that patient treatment has been initiated in a phase 1 clinical trial evaluating IMO-2125 in combination with ribavirin in treatment-naive patients with chronic hepatitis C virus (HCV) infection. IMO-2125 is a novel agonist of Toll-like Receptor (TLR) 9.

7 Oct 2009

Pharmaceutical companies gearing up for cancer vaccine trials following FDA draft guidance

Pharmaceutical companies are gearing up for an increase in running late phase cancer vaccine trials following draft guidance issued by the FDA last week.

From AES - Accelerated Enrollment Solutions 7 Oct 2009

Merz publishes Phase III study results assessing the impact of NT 201 on muscle tone

Data results published this month in Clinical Neuropharmacology, revealed that Merz Pharmaceuticals' NT 201 (botulinum toxin type A free from complexing proteins), also known by the brand name Xeomin in Europe and Canada, was statistically significantly more efficacious than placebo for the treatment of patients with post-stroke upper limb spasticity.

7 Oct 2009

Biovail provides update on its Phase III program with pimavanserin for Parkinson’s disease psychosis

Biovail Corporation today provided an update on its Phase III program with pimavanserin for Parkinson’s disease psychosis (PDP), which is being pursued in collaboration with ACADIA Pharmaceuticals Inc. Following the announcement on September 1st of disappointing top-line results from the first Phase III PDP trial, Biovail and ACADIA remain committed to the successful development of pimavanserin and have established a development strategy that they believe will strengthen the PDP program.

7 Oct 2009

Early Phase II clinical trial for RK-023 to treat androgenetic alopecia

R-Tech Ueno, Ltd. has started early Phase II clinical trial for RK-023, a physiologically active fatty acid derivative developed by the company -- a new compound targeted as a treatment for androgenetic alopecia (male pattern baldness).

7 Oct 2009

Phase 2 clinical study results of TOPICA's luliconazole for athlete's foot announced

TOPICA Pharmaceuticals, a privately-held biotechnology company, today announced positive results from its Phase 2 clinical study evaluating luliconazole, one of the most potent and broad spectrum topical antifungal agents, in patients with tinea pedis (athlete's foot). The study was designed to assess the effectiveness of 1% luliconazole cream applied once daily for 14 days compared with once daily for 28 days.

6 Oct 2009

US Army grants BioDelivery Sciences $1.3M for investigating Bioral Amphotericin B

BioDelivery Sciences International, Inc. has received a $1.3 million grant from the Walter Reed Army Institute of Research for Bioral Amphotericin B, an oral formulation of the fungicidal treatment amphotericin B in BDSI’s patented Bioral drug delivery technology, to further study the formulation in the treatment of Cutaneous Leishmaniasis.

6 Oct 2009

AVANIR's STAR trial Phase III data to be presented at the World Congress on Controversies in Neurology

AVANIR Pharmaceuticals, Inc. today announced it will present detailed data from the Phase III confirmatory STAR trial in the treatment of pseudobulbar affect (PBA) at the 3rd World Congress on Controversies in Neurology (CONy) in Prague, Czech Republic on October 8 - 11, 2009 and the American Neurological Association (ANA) 134th Annual Meeting in Baltimore, MD on October 11 - 14, 2009.

6 Oct 2009

Phase 3 results of Transdel's lead topical pain drug Ketotransdel announced

Transdel Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced positive top-line clinical results for its lead pain drug Ketotransdel®( )in a Phase 3 trial which evaluated the efficacy and safety of the drug in acute soft tissue injuries of the upper and lower extremities.

6 Oct 2009

Vantia Therapeutics announces the start of Phase II proof-of-concept trials of its VA111913 drug

Vantia Therapeutics today announces that its novel oral small molecule drug for the treatment of dysmenorrhoea (painful menstruation) has entered Phase II proof-of-concept trials. In addition, Vantia announces results of the successful Phase I trial of VA111913, which showed the product candidate to be safe and well tolerated.

6 Oct 2009

Drug Trial News

Riley Hospital for Children commences patient enrollment in clinical trial of cystic fibrosis drug

Additional Zenvia Phase III results in multiple sclerosis announced by AVANIR

Plexxikon commences patient dosing in PLX3397 Phase 1 clinical trial

Lpath reports positive Phase 1 clinical trial results of iSONEP in wet-AMD patients

Keryx Biopharmaceuticals commences Phase 2 clinical study evaluating KRX-0401 for Chronic Lymphocytic Leukemia

Paratek Pharmaceuticals and Novartis to collaborate in PTK 0796 broad-spectrum antibiotic development

Macuclear and Mystic announce groundbreaking results from Phase Ib Clinical Trial for Macular Degeneration

Relypsa commences patient enrollment in Phase 2b clinical trial of RLY5016 for treating hyperkalemia

Cipher Pharmaceuticals enrolls first patient in Phase III study of CIP-ISOTRETINOIN

Zelos Therapeutics commences patient dosing of ZT-034 for treating osteoporosis

Idera Pharmaceuticals commences phase 1 IMO-2125 clinical trial for chronic HCV infection

Pharmaceutical companies gearing up for cancer vaccine trials following FDA draft guidance

Merz publishes Phase III study results assessing the impact of NT 201 on muscle tone

Biovail provides update on its Phase III program with pimavanserin for Parkinson’s disease psychosis

Early Phase II clinical trial for RK-023 to treat androgenetic alopecia

Phase 2 clinical study results of TOPICA's luliconazole for athlete's foot announced

US Army grants BioDelivery Sciences $1.3M for investigating Bioral Amphotericin B

AVANIR's STAR trial Phase III data to be presented at the World Congress on Controversies in Neurology

Phase 3 results of Transdel's lead topical pain drug Ketotransdel announced

Vantia Therapeutics announces the start of Phase II proof-of-concept trials of its VA111913 drug

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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