Posts Tagged ‘Clinical trials’

ASX Company News: Cogstate Secures Another New Contract

Wednesday, November 23rd, 2011

CogState Ltd (CGS) announced that it has signed a contract with an international pharmaceutical company to participate in another phase 2b clinical trial for the treatment of Major Depressive Disorder. Under the contract, which will generate US$0.9 million of revenue for CogState over the study duration, CogState will provide its cognitive testing technology and associated services to 280 patients located in 55 sites around the world. The CogState computerized cognition testing software, and associated on-line site training materials, will be provided in 5 languages. In almost five months since 1 July 2011, CogState has signed sales contracts to the value of US$8.2 million, including the above mentioned contract. To give relevance for the large value of contracts signed since 1 July 2011, it is noted that CogState signed US$9.3 million of clinical trial contracts in the full year to 30 June 2011 – at the time, this result was CogState’s best ever result, in respect of the value of contracts signed.

CogState currently has A$9.9 million of contracted revenue that will be recognised in future periods, of which A$5.5 million is expected to be recognised in the 2012 financial year – this is

in addition to the A$3.2 million revenue recorded during the period 1 July – 31 October 2011. CogState Ltd (CGS) specialises in the development and commercialisation of rapid, computerised

tests of cognition (brain function). To date, CogState has commercialised its technology in two markets – clinical drug trials and concussion management in sport. In the clinical drug trial market, CogState technology and associated services are used by pharmaceutical and biotechnology companies to quantify the effect of drugs or other interventions on human subjects participating in clinical trials.

www.cogstate.com

http://www.traderdealer.com.au/fundamentals/cgs

Post to Twitter

Tags: , , , ,
Posted in ASX Company News | No Comments

Prima BioMed Contracts Fraunhofer Institute To Produce Vaccine

Friday, May 28th, 2010

Australian health care company Prima BioMed Ltd (PRR) is pleased to announce that it has entered into an agreement with the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig, Germany (Fraunhofer IZI) to produce Prima’s CVacTM cancer immunotherapy product for the Company’s European clinical trials.

Preparation for production of CVacTM for the European trial has already commenced, and Prima and the Fraunhofer IZI are working together to prepare the facility to support CVacTM clinical trials in Europe in early 2011. This represents a significant milestone on the pathway to commercialisation of CVacTM in the European market.

The agreement also allows Prima to be eligible for millions of Euros in R&D grants from the Saxony Bank (Sächische Aufbaubank – SAB). The SAB grants are intended to assist small companies in product development to achieve success, and would subsidise a significant part of Prima’s production cost for CvacTM. In addition the agreement with Fraunhofer provides a number of other key benefits to Prima. Fraunhofer is among the foremost R&D institutes in Europe and it has strong collaborative networks throughout academia, government, and industry. Fraunhofer will help enhance the visibility of the CVacTM clinical program in Europe and globally.

Prima Chief Operating Officer and Managing Director for Europe, Matthew Lehman said: “The Fraunhofer Institute is among the foremost research and development organisations in the world and Prima is delighted to enter into this collaborative arrangement. Prima values the strong research partnerships we have, including the well-known Peter MacCallum Cancer Centre, the Burnet Research Institute, Stanford University and Fred Hutchinson Cancer Research Centre.”

Prima BioMed is focused on technologies in the fields of cancer immunotherapy and immunology. Prima’s lead product is the CVacTM ovarian cancer therapy treatment. It has completed two successful clinical trials and is progressing toward eventual commercialisation in the United States, Australia, Europe, and globally. The Company’s broader, long term goal is to develop commercial cancer treatment technologies and programs for global markets.

Fraunhofer IZI  is a member of the Fraunhofer Life Sciences Alliance. Its objective is to find solutions to specific problems at the interface between medicine, life sciences and engineering for partners in medicine-related industries and businesses. The Institute’s core competencies are in regenerative medicine, specifically cell-therapeutic methods of regenerating non-functioning tissue and organs through to the biological substitution with tissue cultivated in vitro (tissue engineering). The Institute works especially closely with hospital institutions, performing quality tests and clinical studies on their behalf. It also provides assistance in obtaining manufacturing licenses and certifications.

www.primabiomed.com.au

Post to Twitter

Tags: , , , ,
Posted in ASX Company News | No Comments

Biotron Commence Clinical Trials On Hepatitis C Drug

Friday, March 19th, 2010

The Directors of Biotron Limited (BIT) are pleased to advise that the Company has signed a major international partner to assist trialling the Company’s revolutionary Hepatitis C drug, BIT225. Biotron Limited (BIT) believes its alliance with the prestigious ACLIRES clinical research group will be critical to its success.

Chief Executive Officer Dr Michelle Miller said ACLIRES specialised in running clinical trials for both Hepatitis C and the HIV virus, with fully accredited facilities in South America and Asia. “It has a long history of running successful Phase I and II trials of new drugs, with international pharmaceutical companies and US biotech companies among its clients,” she said. “ACLIRES also has access to large numbers of eligible patient populations. This really is critical to the successful completion of the trial, as one of the biggest risk factors for trials is access to sufficient suitable patients.”

Unlike other Hepatitis C drugs, Biotron’s drug, BIT 225 works by targeting the p7 protein, a viral  protein essential to virus production and replication. The next stage of development is to determine how the drug works in combination with current approved treatments for HCV, Interferon and Ribavairin. At its helm of ACLIRES is well regarded infectious diseases expert, Professor Rob Murphy, currently the Director of the Centre for Global Health at the prestigious Northwestern University in Chicago, USA.

Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need, with a major focus on HIV and HCV. The Company has BIT225 in clinical development for both HIV and HCV, and also has several earlier stage preclinical and research programs for several other viral infections including influenza, Dengue and Hepatitis B.

www.biotron.com.au

Post to Twitter

Tags: , , , ,
Posted in ASX Company News | 2 Comments

CathRX TO Commence Clinical Trials in Asutralia

Thursday, April 30th, 2009

Cardiac catheter manufacturer CathRx Limited (CXD) today announced the John Hunter Hospital had joined its Australian clinical trial to gather data for Australian Therapeutic Goods Administration (TGA) approval for its quadrapolar and decapolar diagnostic catheters. John Hunter Hospital is a leading teaching hospital and major cardiology and cardiac surgery centre. CathRx’s Australian approval trial began at Westmead Hospital in Sydney in November 2008. 

CathRx Chief Executive Officer Neil Anderson said that while the catheters had already been on sale in Europe, the Australian trial was being conducted to enable CathRx to file for Australian approvals. The protocol at John Hunter Hospital calls for use of CathRx’s diagnostic catheters undergoing electrophysiology procedures that require the use of diagnostic catheters. There will be an equal number of CathRx and control patients. The primary end-point is a confirmation of diagnostic capability. 

CathRx is a medical device company which manufactures and sells advanced cardiac catheter systems for the treatment of cardiac arrhythmias. CathRx’s proprietary diagnostic and therapeutic catheters are designed to give physicians the tools to successfully treat patients with speed, safety and precision. CathRx’s first diagnostic products are now on sale in Europe. 

www.cathrx.com.au

Post to Twitter

Tags: , ,
Posted in ASX Company News | No Comments

ACR Contraception Can Be Applied Like Perfume

Monday, February 23rd, 2009

Acrux (ACR) today announced positive results from the latest clinical trials of Nestorone® MDTS®, its unique contraceptive skin spray.  The spray is designed to be a better choice for women using hormonal contraceptive pills or patches.  

Acrux’s trials in Australia with 40 women tested a number of its skin spray formulations, applied to the forearm once a day over 14 days. The amount of hormones in the blood was measured once a day and every 4 hours on day 14.  

Formulations containing Nestorone® and ethinyl estradiol successfully delivered therapeutic amounts of both hormones across the skin into the blood. All spray formulations were well tolerated, with no serious adverse events recorded. 

The next step in the development of the contraceptive spray is expected to be a Phase 2 dose-ranging clinical trial before conducting Phase 3 global registration trials. Through its alliance with Orion Corporation, Acrux will have the capability to provide commercial manufacture and supply of Nestorone® MDTS®. 

“These multi-dose, steady-state results are very exciting and represent the first extended trial of our unique combination contraceptive sprays”, commented Acrux CEO Richard Treagus. “The results with Nestorone®, together with our formulation work on other contraceptive progestins, now place Acrux in a strong position to make commercial progress in this very large market” he added. 

http://www.acrux.com.au/IRM/content/default.html

Post to Twitter

Tags: , , ,
Posted in ASX Company News | No Comments