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Nymox reports positive new results from pooled analysis of NX-1207 clinical trials for BPH

Nymox Pharmaceutical Corporation reported today positive new results from pooled analysis of completed clinical trials of NX-1207, the Company's investigational drug for BPH. The trial data shows that patients receiving NX-1207 recorded significant quantitative improvement in the important symptom of urgent need to urinate.

8 Jul 2010

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

GlaxoSmithKline and XenoPort, Inc. announced today that GSK1838262/XP13512 (gabapentin enacarbil) did not demonstrate a statistically significant improvement compared to placebo as a prophylactic treatment for migraine headaches. This phase 2b dose-ranging study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headache (with or without aura) according to the International Headache Society criteria.

8 Jul 2010

Olaparib shows promising results against inherited forms of breast and ovarian cancer

Olaparib, a new type of experimental drug called a PARP inhibitor, has shown promising results against inherited forms of breast and ovarian cancer in two small clinical trials led by scientists at the Breakthrough Breast Cancer Research Unit at King's College London.

8 Jul 2010

NOXXON to commence multiple ascending dose study of MCP-1 targeting anti-inflammatory Spiegelmer NOX-E36

NOXXON Pharma AG announced today that it has permission to commence a multiple ascending dose study of its Monocyte Chemoattractant Protein-1 (MCP-1) targeting anti-inflammatory Spiegelmer®, NOX-E36. NOXXON plans to develop NOX-E36 for the treatment of diabetic nephropathy and other diabetes related complications.

7 Jul 2010

Neoprobe initiates third multi-center Phase 3 clinical study of Lymphoseek

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced that a third multi-center Phase 3 clinical study of Lymphoseek (NEO3-09) has received investigational review board approval and begun enrollment of subjects diagnosed with breast cancer or melanoma.

7 Jul 2010

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it has initiated dosing in a Phase I human clinical study with ALN-TTR01. The study is aimed at evaluating the safety and tolerability of ALN-TTR01 in patients with transthyretin -mediated amyloidosis, and is also designed to provide preliminary data on human proof of concept based on measurements of TTR serum levels.

7 Jul 2010

Nile completes dosing in CD-NP Phase II study for acute decompensated heart failure

Nile Therapeutics, Inc., a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, today announced that it has completed the dosing of the last patient in NIL-CDNP-CT005, an open-label, single-blind, placebo-controlled Phase II study of CD-NP in patients with acute decompensated heart failure, or ADHF. The study was designed to provide additional information on the safety and tolerability of CD-NP when infused for up to 72 hours in patients with ADHF and mild to moderate renal insufficiency.

7 Jul 2010

Data on activity of Nektar's NKTR-102 in gastrointestinal cancer presented at ESMO 12th World Congress

Nektar Therapeutics announced today that data presented at the European Society for Medical Oncology (ESMO) 12th World Congress on Gastrointestinal Cancer demonstrates that NKTR-102, the company's lead oncology compound, exhibits superior activity compared to irinotecan as part of either a monotherapy or combination regimen in tumor models of gastrointestinal cancers.

7 Jul 2010

Combination of Biothera's Imprime PGG and Erbitux doubles response rate in colorectal cancer patients

The combination of Biothera's experimental drug Imprime PGG® and Erbitux® (cetuximab) doubled the historical overall response rate and the time to progression of second- and third-line metastatic colorectal cancer patients treated with Erbitux monotherapy. The data was released last weekend at the 13th World Congress on Gastrointestinal Cancer at the European Society for Medical Oncology (ESMO).

7 Jul 2010

Capstone Therapeutics to continue AZX100 Phase 2a trial in dermal scarring to planned 12-month endpoints

Capstone Therapeutics announced today it has completed a limited analysis of a subset of data from its ongoing AZX100 Phase 2a clinical trial in trocar site scarring following arthroscopic shoulder surgery. Based on this analysis, the clinical trial will continue to its planned 12-month endpoints.

7 Jul 2010

Genentech submits BLA for trastuzumab-DM1 in advanced HER2-positive breast cancer

Genentech, a member of the Roche Group, today announced that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trastuzumab-DM1 (T-DM1) in people with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies.

7 Jul 2010

Debiopharm's achievement of Phase I milestone in Debio 0932 trial triggers $3M milestone payment to Curis

Curis, Inc. announced today that its licensee Debiopharm S.A. has treated the fifth patient in its ongoing Phase I clinical trial for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305. Under the terms of the August 2009 license agreement between Curis and Debiopharm, Curis will receive a $3 million milestone payment from Debiopharm for the achievement of this development objective.

7 Jul 2010

Initial Phase II study results of ofatumumab in patients with RRMS announced

Genmab A/S announced today positive interim results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis.

7 Jul 2010

FDA accepts DBV Technologies' IND for clinical study of VIASKIN for desensitization to peanut allergy

DBV Technologies (DBV), a biotech company specializing in food allergy with innovative products for diagnosis and treatment, announced today the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application. DBV Technologies will begin clinical investigation of its lead food allergy desensitization candidate, VIASKIN® PEANUT, for the desensitization to peanut allergy. The Company expects to commence recruitment of peanut allergy patients at several medical centers in the U.S. this month.

7 Jul 2010

Phase Ia clinical trial of SYL040012 for treating elevated intraocular pressure, glaucoma completed

Sylentis, a biopharmaceutical subsidiary of Grupo Zeltia and a pioneer in the research and development of new drugs based on gene silencing (interference RNA, RNAi), has completed Phase Ia of its first clinical trial with SYL040012 in the form of ophthalmic drops to treat elevated intraocular pressure and glaucoma.

7 Jul 2010

Crux Biomedical commences enrollment in Retrieve 2 pivotal U.S. IDE trial of new Vena Cava Filter

Crux Biomedical®Inc. announced today that it has successfully enrolled the first patient in its Retrieve 2 pivotal U.S. IDE trial. The trial will evaluate the safety and efficacy of Crux's new Vena Cava Filter (VCF). The Crux VCF is a retrievable, implantable filter which is designed to trap blood clots that can lead to a potentially fatal pulmonary embolism (PE). It is the first VCF to be developed that is bidirectional and thus permits insertion or retrieval from either the femoral or jugular veins.

7 Jul 2010

PuraMed BioScience completes clinical study of LipiGesic M for treating acute migraine

PuraMed BioScience, announced today that a clinical study of LipiGesic M has been completed. The study design was a double blind, placebo controlled, multi-site study measuring the effectiveness of LipiGesic™ M for the treatment of acute migraine attacks. The next steps include completion of the manuscript, submission for publication in a peer-reviewed medical journal and actual publication. In an effort to maximize the potential for publication, an embargo has been placed on the disclosure of any of the results of this study.

7 Jul 2010

FDA grants Angion Biomedica's BB3 therapeutic Fast Track and Orphan Drug product designations

Angion Biomedica Corp., a biopharmaceutical company dedicated to the discovery and development of novel therapeutics that enhance quality of life, eradicate disease and save lives by modulating the body's protective, reparative and regenerative systems, announced today that its lead therapeutic BB3 was accepted into the Fast Track program of the U.S. Food and Drug Administration (FDA) and has also been designated an Orphan Drug product by FDA.

7 Jul 2010

Adeona completes $1 million equity financing and provides update on Zinthionein ZC clinical study

Adeona Pharmaceuticals, Inc., announced today that on July 6, 2010, it completed an equity financing of $1 million with a single institutional investor, Seaside 88, L.P. The financing involved the sale of 1,212,121 registered shares of common stock and no warrants. Enclave Capital served as placement agent and will receive a 7% cash commission and 5-year warrants to acquire 60,606 shares of Adeona at $1.32 per share. The use of proceeds is intended for general corporate purposes.

6 Jul 2010

$CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL$

CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL

Cell Therapeutics, Inc. announced today that it has submitted an expanded Pediatric Investigation Plan to the European Medicines Agency, as part of the process for its submission for a Marketing Authorization Application for pixantrone in the E.U. for the treatment of relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL).

6 Jul 2010

Drug Trial News

Nymox reports positive new results from pooled analysis of NX-1207 clinical trials for BPH

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

Olaparib shows promising results against inherited forms of breast and ovarian cancer

NOXXON to commence multiple ascending dose study of MCP-1 targeting anti-inflammatory Spiegelmer NOX-E36

Neoprobe initiates third multi-center Phase 3 clinical study of Lymphoseek

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Nile completes dosing in CD-NP Phase II study for acute decompensated heart failure

Data on activity of Nektar's NKTR-102 in gastrointestinal cancer presented at ESMO 12th World Congress

Combination of Biothera's Imprime PGG and Erbitux doubles response rate in colorectal cancer patients

Capstone Therapeutics to continue AZX100 Phase 2a trial in dermal scarring to planned 12-month endpoints

Genentech submits BLA for trastuzumab-DM1 in advanced HER2-positive breast cancer

Debiopharm's achievement of Phase I milestone in Debio 0932 trial triggers $3M milestone payment to Curis

Initial Phase II study results of ofatumumab in patients with RRMS announced

FDA accepts DBV Technologies' IND for clinical study of VIASKIN for desensitization to peanut allergy

Phase Ia clinical trial of SYL040012 for treating elevated intraocular pressure, glaucoma completed

Crux Biomedical commences enrollment in Retrieve 2 pivotal U.S. IDE trial of new Vena Cava Filter

PuraMed BioScience completes clinical study of LipiGesic M for treating acute migraine

FDA grants Angion Biomedica's BB3 therapeutic Fast Track and Orphan Drug product designations

Adeona completes $1 million equity financing and provides update on Zinthionein ZC clinical study

CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL

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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