The News Review:
- Framework to be developed to help S’pore fight infectious diseases
- Gene therapy unlikely cause in death
- Researchers acknowledge potential link between vaccine and increased…
- Netherlands Corporate News – Biogen Idec en Elan komen met update…
- Targeted Genetics Announces Positive Interim Phase I/II Results for…
Framework to be developed to help S’pore fight infectious diseases
Channel News Asia – Nov 10, 2007
The focus of the current phase of the Biomedical Sciences Initiative is to bring innovations quickly and safely into clinical practice which will ultimately result in better patient care. But Dr Tan said while translational work is done more effort needs to be put into one other area. “A significant part of the work will have to be done with human subjects and they have to be informed they have to give permission they have to be volunteers so it is necessary to have a public education program to explain why translational and clinical research is beneficial” he explained. Dr Tan added that as more drugs are developed there may be a need to conduct clinical trials in neighbouring countries as well.
Gene therapy unlikely cause in death
Seattle Times – Nov 10, 2007
Philip Mease chief of rheumatology clinical research at Swedish Medical Center and lead investigator for the Targeted Genetics clinical trial said that the independent data-monitoring committee for the study also had concluded the company’s compound “had nothing to do with her reason for death. Mease is scheduled to make a presentation on the Targeted Genetics therapy this afternoon at a scientific meeting in Boston. Another NIH panel is scheduled to meet early next month to discuss the complete data. The FDA has yet to decide whether the Targeted Genetics clinical trial can be resumed. Ángel González: 206-515-5644 or agonzalez@seattletimes.comCopyright © 2007 The Seattle Times CompanyMore Business & Technology headlines.
Researchers acknowledge potential link between vaccine and increased…
Seattle Gay News – Nov 10, 2007
That is those volunteers who received the vaccine and who had very high levels of immunity to Ad5 because of earlier exposure to it were more likely to acquire HIV. “The data from this trial are remarkably complex. We are analyzing the data to try to determine if the results are due to immune responses induced by the vaccine differences in study populations or some other biological phenomenon we don’t yet understand or simply due to chance” said Keith Gottesdiener M. Vice President of Merck’s Vaccine and Infectious Disease Clinical Research. “It will take some time before we understand why the vaccine did not work and why there was a trend toward more cases of infection in volunteers who received the vaccine. ” Last week a clinician involved with the Seattle STEP trials echoed the need to take caution in analyzing that trend.
Netherlands Corporate News – Biogen Idec en Elan komen met update…
Netherlands Corporate News – Netherlands Corporate News (persbericht) – Nov 10, 2007
“Neurologists and patients are increasingly choosing TYSABRI givenits significant impact on clinically meaningful and relevantendpoints including relapses and disability progression. Ultimatelywe believe the full potential of TYSABRI will be realized making itthe leading MS therapy” said Michael Panzara MD MPH Vice Presidentand Chief Medical fficer Neurology Strategic Business Unit BiogenIdec. “Continued patient experience and ongoing clinical research willfurther differentiate TYSABRI as a valuable treatment option for MSpatients around the world. TYSABRI is currently approved in more than20 countries and we hope to offer this therapeutic alternative tomore patients in the future” said Gordon Francis MD Senior VicePresident Global Clinical Development Elan. About TUCH and TYGRIS Before initiating treatment all US patients prescribers andinfusion sites must be enrolled in the TUCH Prescribing Program(TYSABRI utreach: Unified Commitment to Health). TUCH is designed todetermine the incidence of and risk factors for serious opportunisticinfections (Is) including PML and to monitor patients for signs andsymptoms of PML while promoting informed benefit-risk discussionsprior to initiating TYSABRI treatment. Physicians report on PMLserious Is deaths and discontinuation of therapy on an ongoingbasis.
Targeted Genetics Announces Positive Interim Phase I/II Results for…
Genetic Engineering News – Genetic Engineering News (press release) – Nov 10, 2007
clinical professor at the University ofWashington School of Medicine chief of rheumatology clinical researchat the Swedish Medical Center practicing physician with SeattleRheumatology Associates and the lead investigator on the trialreported data from 66 subjects enrolled in the Phase II portion ofthe trial who were given a self-administered patient questionnaire todetermine improvements in joint symptoms and pain management. Ahigher percentage of subjects who received tgAAC94 reportedimprovement in joint symptoms function and pain compared to theplacebo injected group:– 40% of tgAAC94 compared to 19% placebo injected patients reported a 30% decrease in injected joint global symptoms on visual-analog scale– 32% of tgAAC94 compared to 19% placebo injected patients reported a 30% improvement in injected joint function on visual-analog scale– 12% of tgAAC94 compared to 6% placebo injected patients reported 2- point decrease in injected joint pain on visual-analog scale These interim data also indicated that tgAAC94 is well-tolerated fordoses up to 5×1013 DNase Resistant Particle (DRP). The most commonadverse events noted were injection site reactions seen in 10% ofpatients treated. Mease reviewed data generated in the investigation of the causeof the July SAE.
