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Pharmaceutical companies gearing up for cancer vaccine trials following FDA draft guidance

Pharmaceutical companies are gearing up for an increase in running late phase cancer vaccine trials following draft guidance issued by the FDA last week.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

PDS Biotechnology's Versamune-based immunotherapy drug demonstrates safety in preclinical studies

PDS Biotechnology Corporation today announced that the company has completed GLP toxicology studies of its lead HPV-cancer product. The studies, which included pharmacokinetic (PK) and adsorption, bio-distribution and excretion (ADE) studies in addition to the evaluation of toxicity, all demonstrated a very safe profile of the drug and PDS Biotech's platform Versamune((TM)) technology.

6 Oct 2009

OncoGenex' OGX-011 receives additional FDA Fast Track Designation for treating metastatic prostate cancer

OncoGenex Pharmaceuticals, Inc. announced today that OGX-011, also known as custirsen sodium, received an additional Fast Track Designation from the U.S. Food & Drug Administration (FDA) for progressive metastatic prostate cancer in combination with first-line docetaxel treatment.

6 Oct 2009

EP-100 membrane-disrupting peptide drug for cancer being tested at TCRS

A new drug designed to "seek and destroy" common cancers such as breast, prostate, endometrial, pancreatic, ovarian, skin and testicular cancers is being tested at TGen Clinical Research Services (TCRS) at Scottsdale Healthcare.

6 Oct 2009

ThromboGenics presents Phase IIa microplasmin intravitreal injection trial results at the ASRS conference

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative medicines for eye disease, vascular disease and cancer, today announces results of a Phase IIa trial evaluating microplasmin intravitreal injection for the treatment of Diabetic Macular Edema (MIVI II DME).

6 Oct 2009

ArQule completes patient enrollment in ARQ 197 Phase 2 trial for non-small cell lung cancer

ArQule, Inc. (Nasdaq: ARQL) today announced that patient enrollment in a Phase 2 trial with ARQ 197 in non-small cell lung cancer (NSCLC) has been completed.

5 Oct 2009

Alnara to announce Phase 3 study results of liprotamase for treating cystic fibrosis at the 23rd NACFC

Alnara Pharmaceuticals, Inc., a pharmaceutical company developing novel, non-systemic orally-delivered protein therapeutics for the treatment of metabolic diseases, announced today that results from a landmark, international Phase 3 study of the long-term safety and nutritional benefits of liprotamase for the treatment of pancreatic insufficiency in patients with cystic fibrosis (CF) will be presented at the 23rd Annual North American Cystic Fibrosis Conference (NACFC) being held October 15-17, 2009 in Minneapolis, Minnesota.

5 Oct 2009

Drug Trial News

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

PDS Biotechnology's Versamune-based immunotherapy drug demonstrates safety in preclinical studies

OncoGenex' OGX-011 receives additional FDA Fast Track Designation for treating metastatic prostate cancer

EP-100 membrane-disrupting peptide drug for cancer being tested at TCRS

ThromboGenics presents Phase IIa microplasmin intravitreal injection trial results at the ASRS conference

ArQule completes patient enrollment in ARQ 197 Phase 2 trial for non-small cell lung cancer

Alnara to announce Phase 3 study results of liprotamase for treating cystic fibrosis at the 23rd NACFC

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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