Trials in Biological Technology

Catalyst Pharmaceutical Partners Reports Second Quarter 2009 Financial Results

... us to pursue future clinical and non-clinical trials of CPP-109." "We are currently evaluating ... CPP-109, including the clinical and non-clinical trials that will be required for us to file an NDA for ... the NIH umbrella, for future vigabatrin addiction trials and to provide a portion of the required funding ...

InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

... reflecting completion of the CAPACITY clinical trials in early 2009, partially offset by expenses ... endpoint in one of its two pivotal clinical trials and there can be no assurance that the regulatory ... (ix) the results of the InterMune CAPACITY trials of pirfenidone differ in some respects from those ...

Curis and Debiopharm Sign an Exclusive License Agreement Covering the HSP90 Inhibitor CUDC-305

... Genentech's ongoing Phase II clinical trials of GDC-0449, a Hedgehog Pathway Inhibitor, in ... corporate benefits of any advancement of clinical trials of GDC-0449;. Forward-looking statements used in ... Genentech may not be able to replicate in later trials any favourable outcomes from ...

GeoVax Labs, Inc. Provides Clinical Studies Update

... This trial was initiated by the HIV Vaccine trials Network (HVTN) in February this year and we are ... quarter of 2010." Preventative Clinical trials - Phase 2a The preventative trial, designated ... (NIAID), is the largest worldwide clinical trials network dedicated to the development and testing ...

Shire plc: Core Portfolio of Products Delivers 20% Sales Growth

... We are also initiating Phase 2 pilot clinical trials to assess the efficacy and safety of VYVANSE in ... - Shire is conducting Phase 2 pilot clinical trials to assess the efficacy and safety of ... Results from the first of the three Phase 3 trials were positive, and achieved statistically ...

The Foundation for National Institutes of Health Announces Unprecedented Product Donation by sanofi-aventis in the U.S.

... therapies for ongoing use in clinical trials and other therapeutic treatments at the National ... "At a time when the costs of managing clinical trials are on the rise and budgets are extremely tight, ... of which are clinical trials. These clinical trials play a crucial role in evaluating potential ...

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

... double-blind, placebo-controlled clinical trials in acute GI GVHD with orBec((R)). The first trial ... and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, ... due to difficulties or delays in clinical trials or due to lack of progress or positive results ...

Palatin Technologies, Inc. Receives U.S. Patent Allowance for Heart Failure Drug Candidate

... PL-3994 Palatin has completed two clinical trials with PL-3994, a Phase 1 trial in healthy ... to establish and successfully complete clinical trials and pre-clinical studies and the results of those trials and studies, dependence on its partners for ...

OmniComm Systems Acquires EDC Assets of Leading Phase I Clinical Software Vendor - Logos Technologies, Ltd.

... data capture (EDC) solutions for clinical trials announced today that the company has acquired the ... Phase I clinical trials. Phase I clinical trials are the first stage of the US or International ... management. Regular EDC solutions for later stage trials do not include a pro-active data collection ...

Jatropha Couple Oil Crop Cultivation Technology Commercially Released

... The years of continuous research, experiments and trials have given Centre for Jatropha Promotion & ... The years of continuous research, experiments and trials have given Centre for Jatropha Promotion & ... years of continuing research, experiments and trials has provided an adage to find and develop 2nd ...

Terrosa Technologies Assigned as Exclusive Reseller for Inclinicalperform CTMS/SaaS Clinical Trials Collaboration Software

... information that is created during the clinical trials process. Thousand ... information that is created during the clinical trials process. With this agreement, Terrosa will ... information that is created during the clinical trials process. "Our software makes the clinical ...

ERT Reports Second Quarter 2009 Results

... Sponsors may delay the running of Thorough QT trials until later in the drug development cycle, though ... of ECGs, increased use of ePRO in clinical trials and increasing our market share." 2009 ... and services to streamline the clinical trials process by enabling its customers to automate the ...

Sunesis Reports Financial Results for the Second Quarter 2009

... presented new data from three ongoing clinical trials demonstrating that voreloxin shows promising ... various reasons, the risk that Sunesis' clinical trials for voreloxin may not demonstrate safety or ... that Sunesis' nonclinical studies and clinical trials may not satisfy the requirements of the FDA or ...

Seasoned Dermatologist Nissan Pilest of Irvine, CA, Joins SDS Clinical Trials as Clinical Investigator for Dermatology Division

... Nissan Pilest , has been selected by SDS Clinical trials located in California to participate in their ... Board Certified Dermatologist, will carry out the trials at his medical and cosmetic dermatology clinic, ... brought him to the attention of SDS Clinical trials administrator Nanci Hook-Seid. "We're ...

Northwest Biotherapeutics Announces Plans to De-list From AIM and Consolidate its Stock Market Listing in U.S.

... to raise additional capital to fund its clinical trials and other operating activities, and repay ... III trial in prostate cancer, and for Phase I trials in five other cancers. The Company has started, ... ability to enroll patients in its clinical trials and complete ...

Dow AgroSciences, Monsanto Complete U.S. and Canadian Regulatory Authorizations for SmartStax Corn; Plans Set to Launch Seed Platform on 3 Million- to 4 Million-Plus Acres

... Plans Two years of pre-registration field trials conducted by Dow AgroSciences shows that ... traits currently on the market. In corn rootworm trials during 2007 and 2008, SmartStax more ... than first generation insect traits. Results of trials conducted by Dow AgroSciences against the most ...

BioMS Medical announces second quarter 2009 results

... this year. This is the first of our two pivotal trials evaluating dirucotide in patients with secondary ... BioMS is conducting two pivotal clinical trials and one open-label follow-on trial of dirucotide ... being evaluated in two pivotal phase III clinical trials for Secondary Progressive MS patients, MAESTRO-01 ...

VIA Pharmaceuticals Receives Anticipated Notice From NASDAQ

... our ability to successfully complete our clinical trials of VIA-2291 on expected timetables and the ... and implementing cardiometabolic clinical trials using surrogate endpoints in Phase 1 and Phase 2 clinical trials which may differ from the ultimate endpoints ...

Encorium Group Completes Sale of its U.S. Business to Pierrel Research USA; Announces Management Changes

... and management capabilities for clinical trials and patient registries to many of the world's ... in the design and management of complex clinical trials and Patient Registries for the pharmaceutical, ... (iii) the size, duration and timing of clinical trials we are currently managing may change ...

Sumavel(TM) DosePro(TM) (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System

... adverse events observed in controlled clinical trials with sumatriptan injection were injection site ... lasted for only a short time. In clinical trials comparing the safety and tolerability of Sumavel ... 9,000 injections have been delivered in clinical trials in healthy volunteers using the DosePro ...

Covance to Sell Its Interactive Voice and Web Response Services and Enter Into a Multi-Year Marketing Agreement with Phase Forward

... used in the management and oversight of clinical trials such as electronic data capture, bedside data ... integrated data management solutions for clinical trials and drug safety. Phase Forward's products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial ...

University of Florida Shands Cancer Center Selects OnCore(r) to Support its Collaborative Research Goals

... "We began looking for a new clinical trials management system primarily because of our ... Moore-Higgs, Assistant Director of Clinical trials at UFSCC. "We wanted a system that would ... to accomplish this, the cancer center clinical trials office will roll-out the system first. Once that ...

DOR BioPharma Announces Issuance of European Patent for its LPM(TM) Oral Drug Delivery Technology

... and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, ... due to difficulties or delays in clinical trials or due to lack of progress or positive results ... requirement that DOR conduct additional clinical trials to demonstrate the safety and efficacy of ...

New Report Just Published: World Prostate Cancer Therapeutics Market Report

... Delay Market Approval II-12 Ongoing Clinical trials in Hormone Refractory Prostate Cancer II-12 Challenges Encountered in Clinical trials II-12 Notable Prostate Cancer Drug Failures ... Developing Countries II-13 2. Clinical trials II-14 Drugs in Pipeline II-14 Select ...

GeoVax Labs, Inc. Announces Resignation of Director

... vaccines have moved forward in human clinical trials conducted by the HIV Vaccine trials Network (HVTN) based in Seattle, Washington. The ... Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing ...

Encorium Group Updates Expected Timeframe with Respect to the Sale of its U.S. Business

... and management capabilities for clinical trials and patient registries to many of the world's ... in the design and management of complex clinical trials and Patient Registries for the pharmaceutical, ... (iii) the size, duration and timing of clinical trials we are currently managing may change ...

Peregrine Awarded European Patent for Innovative Labeling Technology Featured in New Study in The Journal of Nuclear Medicine

... antibody Cotara(R), currently in Phase II trials for the treatment of glioblastoma multiforme, a ... to produce Cotara for our ongoing brain cancer trials and can report that it works as well in clinical ... of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral ...

DOR BioPharma Announces Publication of orBec(R) Clinical Pulmonary Data in Bone Marrow Transplantation

... placebo-controlled Phase 2 and 3 clinical trials evaluating orBec(R), for the treatment of acute ... 109: 4557 - 4563, 2007). "While these trials were not designed to look at pulmonary endpoints, ... ingestion of an oral pro-drug (BDP). Clinical trials examining this novel pulmonary delivery system in ...

Cordex Completes Production of ATPace(TM) Clinical Trial Material

... clinical trials. The protocol of these clinical trials has been approved by the U.S. Food and Drug ... Inc. The CTM will be used in the planned clinical trials for the acute treatment of patients presenting ... ATPace(TM) and the use of the CTM in the planned trials and the use of the European data as part of the ...

OncoGenex Pharmaceuticals Files Shelf Registration Statement

... shelf registration to fund our Phase 3 clinical trials for OGX-011." OncoGenex elected to terminate ... that has completed five Phase 2 clinical trials in prostate, lung and breast cancers, is designed ... clinical trials, the timing and costs of clinical trials and regulatory approvals will be different than ...

Preclinical Proof-of-Concept Studies Published for Novavax Seasonal Influenza Virus-Like-Particle Vaccine

... of this study, which supported the human clinical trials of our seasonal influenza VLP vaccine," said Dr. ... progress of its preclinical studies and clinical trials and other research and development activities; ... if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe ...

OncoGenex Pharmaceuticals Completes Amendment to Phase 3 Special Protocol Assessment for Confirming Survival Benefit in Patients Receiving OGX-011 with First-Line Docetaxel for Metastatic Prostate Cancer

... as well as both endpoints, in our Phase 3 trials better positions the availability of OGX-011 ... resistance, and has completed Phase 2 clinical trials in prostate, lung and breast cancer. Based on ... intends to conduct two Phase 3 registration trials with OGX-011 in metastatic castrate resistant ...

YM BIOSCIENCES REPORTS DAIICHI-SANKYO ENROLLS FIRST PATIENTS IN PHASE II, FIRST-LINE LUNG CANCER TRIAL WITH NIMOTUZUMAB

... "This is the latest of eleven Phase II and III trials currently being conducted by YM and/or its four ... description of the completed and ongoing trials being conducted by YM and the other licensees of ... partners will complete their respective clinical trials within the timelines communicated in this ....

Amgen to Participate in Reproductive Health Drugs Advisory Committee Meeting in August

... forward to discussing the data from our denosumab trials in these settings with the members of the ... BLA submission contains data from six Phase 3 trials involving more than 11,000 patients and ... of time that it takes for us to complete clinical trials and obtain regulatory approval for product ...

GeoVax Signs HIV/AIDS Vaccine Proposal With Health and Hospital System of Cook County, Illinois

... against HIV/AIDS by accelerating the clinical trials of the DNA/MVA and MVA/MVA vaccines developed by ... the surrounding region to participate in clinical trials of vaccines with the potential to protect against ... CORE Center conducting some of the clinical trials in Cook County. The participation proposed would ...

Data Presented at Society of Nuclear Medicine 2009 Annual Meeting Supports Potential of Peregrine's Cotara(R) for the Treatment of Brain Cancer

... of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral ... of Cotara or the risk that results from larger trials may not be consistent with the results of earlier ... with completing preclinical and clinical trials for our technologies; the early stage of product ...

Sinovac Completes Construction of H1N1 Virus Seed Bank

... of the first batch and initiate clinical trials of an H1N1 vaccine by the end of July 2009. ... track and we look forward to initiating clinical trials by the end of next month. Sinovac's rapid ... subsidiary, Tangshan Yian, is conducting field trials for independently developed inactivated animal ...

New Phase 3 Data Continue to Indicate that Wyeth's Investigational 13-valent Vaccine Has the Potential to Broaden Coverage Against Pneumococcal Disease

... -- New data from Phase 3 European clinical trials reinforce that Wyeth's (NYSE: WYE ) ... frequently reported adverse events in the Phase 3 trials included injection site reactions, (redness, ... is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected ...

Human Genome Sciences Reports Positive Long-Term Data for BENLYSTA(TM) (Formerly LymphoStat-B(R)) in Patients With Active Systemic Lupus Erythematosus

... if Phase 2 results are confirmed in the Phase 3 trials that are currently ongoing." BENLYSTA(TM) ... BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. BENLYSTA is ... as the primary efficacy endpoint of the Phase 3 trials (defined by an improvement in SELENA SLEDAI score ...

Orexigen(R) Therapeutics Presents Additional NB-302 Contrave(R) Data at American Diabetes Association (ADA) 69th Scientific Sessions

... secondary findings from the first of four Phase 3 trials of its lead investigational product Contrave(R) ... year. Results from the three other Phase 3 trials (NB-301, NB-303, NB-304) are expected to be ... in the central nervous system. Based on clinical trials completed to date, Contrave is believed to ...