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Company's End-of-Phase II Meeting with FDA Set for Sept. 29
LA JOLLA, Calif., June 30 /PRNewswire/ -- TorreyPines Therapeutics,
Inc. (Nasdaq: TPTX ) today announced that data presented at the 50th Annual
Scientific Meeting of the American Headache Society showed that, in
addition to mee...
...survey was conducted online between March 25 and April 1, 2009, by Harris Interactive. There were 1801 completed surveys received from respondents who met the screening criteria. The survey included 889 U.S. women with postmenopausal osteoporosis and 912 postmenopausal women who did not have osteoporosis...
...the PAS-Port and control grafts. Over 90 percent of the patients received these angiograms. The data published show that the PAS-Port system met the primary efficacy endpoint of non-inferiority in patency at nine-month follow up compared to hand-sewn anastomoses. In addition, of the 12 major ad...
...ic toxicities. Activity was demonstrated in a number of solid tumor types. A phase II study of brostallicin in relapsed/refractory soft tissue sarcoma met its pre-defined activity and safety hurdles and resulted in a first-line phase II study that is currently being conducted by the European Organization...
...ertainty was applied. ARTEN follow-up is currently planned to continue for a total of 144 weeks. "We're pleased to see that the ARTEN study met its primary endpoint," said Peter Piliero, M.D., executive director of Medical Affairs, Virology for Boehringer Ingelheim Pharmaceuticals, Inc. "The s...
...BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) met the primary endpoint in BLISS-52, the first of two...ofile was comparable overall to placebo. BENLYSTA met the primary endpoint in this Phase 3 study at a ro...on an intention-to-treat (ITT) analysis, belimumab met its primary efficacy endpoint of superior...
...o-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to...
...nver Health Hospital. Testing was performed at Great Basin Scientific's lab in Longmont, Colo. "The results of the pre-clinical study completely met our expectations and keep us right on track as we approach clinical trials," said Rob Jenison, Great Basin Scientific's chief technology officer and v...
...ality of life data were collected again at weeks eight and sixteen(3). Tadalafil increased 6MWD in a dose-dependent manner, only the 40 mg dose met the pre-specified level of statistical significance of less than 0.01 (p<0.01). Overall, the placebo-corrected treatment effect was 33m (95 percent...
...ents studied did not have aortic valve replacement surgery even though they met established criteria Symptoms of severe aortic stenosis are under-dia...er 75 percent did not have valve replacement (AVR) surgery even though they met echocardiographic criteria. "Patients are not being referred for aorti...
...of 21 patients have an MRD response. Currently, 13 of 16, or 81% of evaluated patients have shown an MRD response, thus qualifying the trial as having met its primary endpoint before the completion of the study. Patients in all subgroups responded to treatment with blinatumomab, including bcr-abl positiv...
...rtic insufficiency) were similar between treatment groups. Lorcaserin met the primary safety endpoint of no significant difference in rates of valvul...t contains two alternate efficacy benchmarks, only one of which needs to be met for approval. The guidance provides that, in general, a product can be cons...
...DAI) score of at least 70 points over the course of 12 weeks; the more stringent criterion of at least a 100 point decrease in the CDAI score was also met by week 12. In addition, Traficet-EN treatment resulted in colonoscopic evidence of improvement. These data, reported from the Induction Stage of th...
...of Clinical Oncology (ASCO) meeting in Orlando. Results show that the study met its primary endpoint, demonstrating that the addition of vandetanib to doce...ting a statistically significant prolongation of PFS for vandetanib was not met in this study, in a pre-planned non-inferiority analysis, vandetanib was sh...
...ompared to the subjects receiving the H5N1 influenza vaccine alone. Thus this was the first time that a single dose of H5N1 pandemic influenza vaccine met the level of protection suggested in U.S. Food and Drug Administration guidance that a pandemic vaccine needs to achieve immune response levels in at ...
...d the GeoVax Labs awareness campaign as an advocate of the Company's promising HIV/AIDS Vaccine, currently in Phase 2a human trials. Mr. Panozzo met GeoVax's lead scientist, Dr. Harriet Robinson, at a recent awareness campaign in Ybor City, Tampa, Florida. He noted, "I was sincerely touched by her...
...edicted Forced Vital Capacity (FVC) at Week 72 was met with statistical significance in CAPACITY 2 (p=0.0...ival (PFS) and categorical change in FVC were also met with statistical significance. The primary endpoint was not met in CAPACITY 1 (p=0.501), but supportive evidence o...
...ouble-blind, placebo-controlled, long-term study was conducted to evaluate the effect of RISPERDAL(R) CONSTA(R) as maintenance therapy in patients who met DSM-IV criteria for Bipolar I Disorder who were stable on medications or experiencing an acute manic or mixed episode. In the first phase of the study...
...vious successful randomized, placebo-controlled, Phase II trials which both met their primary endpoint with supporting results on the secondary endpoints. ...om two randomized placebo-controlled Phase II trials. Both Phase II trials met their primary endpoint with supporting results on the secondary endpoints. ...
...dings on INTUNIV (guanfacine) extended release, a selective alpha-2A-agonist, at a major psychiatric meeting. This randomized placebo controlled trial met its primary objective, which was to evaluate the effects of INTUNIV on oppositional symptoms in children aged 6 to 12 years with a diagnosis of ADHD a...
... CARLSBAD, Calif., May 17 /PRNewswire/ -- Essentialis Inc, a clinical stage pharmaceutical company, announced today that it met its primary endpoint of statistically significant triglyceride reduction in a 90-patient Phase 2b trial of DCCR in dyslipidemic patients. The study en...
...h/20090413/LA97352LOGO ) Dr. Louie presented the positive top-line results that the Company had previously announced in November 2008. The trial met its primary endpoint with fidaxomicin achieving clinical cure compared to Vancocin(R). In addition, patients treated with fidaxomicin experienced a re...
...today announced that the MDX-1100 Phase 2 proof-of-concept trial in patients with active rheumatoid arthritis (RA) receiving methotrexate successfully met its primary endpoint. The top-line results from the recently completed 70-patient multi-center, randomized, double-blind, placebo-controlled Phase 2 t...
...ered to patients within 96 hours of an Acute Coronary Syndrome (ACS) event, met its primary endpoint of a reduction in Low Density Lipoprotein Cholesterol ...y and several secondary endpoints, clinical data from the FRANCIS study has met and/or exceeded our expectations and we hope to present the entire data set...
Primary Endpoint Met in Phase 2 Trial of Daclizumab in Patients With Relapsing Multiple Sclerosis
- Anti-IL-2 receptor antibody significantly reduced the number of new or enlarged lesions compared to placebo; data to be submitted for presentation at upcoming medical meeting - CAMBRIDGE, Mass. and FREMONT, Calif., March 12, 2007 /PRNewswire-FirstCall/ -- Biogen Idec, Inc. and PDL BioPharma, Inc...Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009
...omozygous FH patients. We reported that the study met its primary endpoint with a 25% reduction in LDL-C... 3 data in patients with homozygous FH. The study met its primary endpoint, with a 25% reduction in LDL-..., vs. 3% for placebo (p<0.001). The study also met each of its three secondary endpoints of reduction...Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
...was the change in total PANSS score from baseline to endpoint. Each of the three additional acute treatment studies involving INVEGA(R) SUSTENNA(TM) met its primary endpoint of significantly improving PANSS scores relative to placebo. The efficacy of INVEGA(R) SUSTENNA(TM) in maintaining symp......survey was conducted online between March 25 and April 1, 2009, by Harris Interactive. There were 1801 completed surveys received from respondents who met the screening criteria. The survey included 889 U.S. women with postmenopausal osteoporosis and 912 postmenopausal women who did not have osteoporosis...
...the PAS-Port and control grafts. Over 90 percent of the patients received these angiograms. The data published show that the PAS-Port system met the primary efficacy endpoint of non-inferiority in patency at nine-month follow up compared to hand-sewn anastomoses. In addition, of the 12 major ad...
...ic toxicities. Activity was demonstrated in a number of solid tumor types. A phase II study of brostallicin in relapsed/refractory soft tissue sarcoma met its pre-defined activity and safety hurdles and resulted in a first-line phase II study that is currently being conducted by the European Organization...
...ertainty was applied. ARTEN follow-up is currently planned to continue for a total of 144 weeks. "We're pleased to see that the ARTEN study met its primary endpoint," said Peter Piliero, M.D., executive director of Medical Affairs, Virology for Boehringer Ingelheim Pharmaceuticals, Inc. "The s...
First Potential Lupus-Specific Treatment in Sight
...lop new, safe, and effective therapies for lupus. We are greatly encouraged by the positive top-line data which shows that HGS' 52-week BENLYSTA study met its primary endpoint. These results provide hope that this complex chronic autoimmune disease can be brought under control and that, eventually, a cur......BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) met the primary endpoint in BLISS-52, the first of two...ofile was comparable overall to placebo. BENLYSTA met the primary endpoint in this Phase 3 study at a ro...on an intention-to-treat (ITT) analysis, belimumab met its primary efficacy endpoint of superior...
...o-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to...
Landmark Study for GSK's Cervical Cancer Vaccine Published in The Lancet
...ntrol=9325) Total vaccinated cohort-naive (TVC-naive; vaccine=5822; control=5819) ATP-E included all women who met eligibility criteria, complied with the trial protocol and received all three doses of study vaccine TVC included all women who received at le...MADIT-CRT Trial Meets Primary Endpoint
...-- Boston Scientific Corporation (NYSE: BSX ) and the University of Rochester Medical Center today announced that the landmark MADIT-CRT trial has met its primary endpoint. Preliminary results show Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) to be associated with a si...Inspiration for 'My Sister's Keeper' Speaks Out
... Cameron Diaz on Friday. With the help of Denver infertility specialist Dr. William B. Schoolcraft, the Nashes were able to select an embryo that met two criteria: it didn't carry the genetic abnormality that would cause Fanconi Anemia (FA), an often-fatal genetic disease, and it was a tissue match ......nver Health Hospital. Testing was performed at Great Basin Scientific's lab in Longmont, Colo. "The results of the pre-clinical study completely met our expectations and keep us right on track as we approach clinical trials," said Rob Jenison, Great Basin Scientific's chief technology officer and v...
CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Advanced Breast Cancer
...ion (Nasdaq: CRGN ) announced today that its Phase I/II Trial evaluating CR011-vcMMAE for the treatment of patients with advanced breast cancer has met the efficacy criteria for advancement to the second stage of enrollment. To date, 29 patients have been enrolled in this trial, including 15 in the Ph......ality of life data were collected again at weeks eight and sixteen(3). Tadalafil increased 6MWD in a dose-dependent manner, only the 40 mg dose met the pre-specified level of statistical significance of less than 0.01 (p<0.01). Overall, the placebo-corrected treatment effect was 33m (95 percent...
...ents studied did not have aortic valve replacement surgery even though they met established criteria Symptoms of severe aortic stenosis are under-dia...er 75 percent did not have valve replacement (AVR) surgery even though they met echocardiographic criteria. "Patients are not being referred for aorti...
...of 21 patients have an MRD response. Currently, 13 of 16, or 81% of evaluated patients have shown an MRD response, thus qualifying the trial as having met its primary endpoint before the completion of the study. Patients in all subgroups responded to treatment with blinatumomab, including bcr-abl positiv...
...rtic insufficiency) were similar between treatment groups. Lorcaserin met the primary safety endpoint of no significant difference in rates of valvul...t contains two alternate efficacy benchmarks, only one of which needs to be met for approval. The guidance provides that, in general, a product can be cons...
WORLD'S First Robotic Assisted Kidney Transplant Performed at Saint Barnabas Medical Center
...m and Maureen Schrader, it was transformational. When Jim and Maureen met five years ago, they knew they were a perfect love match but they never rea...lant Division at Saint Barnabas Medical Center. Once at the hospital, they met the transplant team and learned about the road ahead. They discussed all o...CuraGen Updates CR011-vcMMAE Data at ASCO
.... Of the patients enrolled, 94% had Stage IV disease of which two-thirds were classified as M1c, the poorest risk group. The study successfully met its primary activity endpoint, with 5 objective responses (1 unconfirmed) observed in 34 evaluable patients, and median duration of response of 5.3 mo......DAI) score of at least 70 points over the course of 12 weeks; the more stringent criterion of at least a 100 point decrease in the CDAI score was also met by week 12. In addition, Traficet-EN treatment resulted in colonoscopic evidence of improvement. These data, reported from the Induction Stage of th...
...of Clinical Oncology (ASCO) meeting in Orlando. Results show that the study met its primary endpoint, demonstrating that the addition of vandetanib to doce...ting a statistically significant prolongation of PFS for vandetanib was not met in this study, in a pre-planned non-inferiority analysis, vandetanib was sh...
...ompared to the subjects receiving the H5N1 influenza vaccine alone. Thus this was the first time that a single dose of H5N1 pandemic influenza vaccine met the level of protection suggested in U.S. Food and Drug Administration guidance that a pandemic vaccine needs to achieve immune response levels in at ...
Stand Up To Cancer Awards $73.6 Million for Novel, Groundbreaking Cancer Research
... and then eight. At that point, finalists were invited to submit full-blown research proposals. The leaders of each of the eight finalist teams met in-person with the SAC to present the plans for their research, and respond to questions about their projects - a level of interaction between applica...PharmAthene Submits SparVax(TM) Regulatory Strategy to FDA
...tions with HHS under the proposals process. David P. Wright, President and Chief Executive Officer of PharmAthene, noted, "We are pleased to have met our stated goal of submitting our regulatory plan to FDA by May 21st, well ahead of the June 15th submission deadline. We feel we have presented a co......d the GeoVax Labs awareness campaign as an advocate of the Company's promising HIV/AIDS Vaccine, currently in Phase 2a human trials. Mr. Panozzo met GeoVax's lead scientist, Dr. Harriet Robinson, at a recent awareness campaign in Ybor City, Tampa, Florida. He noted, "I was sincerely touched by her...
...edicted Forced Vital Capacity (FVC) at Week 72 was met with statistical significance in CAPACITY 2 (p=0.0...ival (PFS) and categorical change in FVC were also met with statistical significance. The primary endpoint was not met in CAPACITY 1 (p=0.501), but supportive evidence o...
...ouble-blind, placebo-controlled, long-term study was conducted to evaluate the effect of RISPERDAL(R) CONSTA(R) as maintenance therapy in patients who met DSM-IV criteria for Bipolar I Disorder who were stable on medications or experiencing an acute manic or mixed episode. In the first phase of the study...
...vious successful randomized, placebo-controlled, Phase II trials which both met their primary endpoint with supporting results on the secondary endpoints. ...om two randomized placebo-controlled Phase II trials. Both Phase II trials met their primary endpoint with supporting results on the secondary endpoints. ...
...dings on INTUNIV (guanfacine) extended release, a selective alpha-2A-agonist, at a major psychiatric meeting. This randomized placebo controlled trial met its primary objective, which was to evaluate the effects of INTUNIV on oppositional symptoms in children aged 6 to 12 years with a diagnosis of ADHD a...
... CARLSBAD, Calif., May 17 /PRNewswire/ -- Essentialis Inc, a clinical stage pharmaceutical company, announced today that it met its primary endpoint of statistically significant triglyceride reduction in a 90-patient Phase 2b trial of DCCR in dyslipidemic patients. The study en...
...h/20090413/LA97352LOGO ) Dr. Louie presented the positive top-line results that the Company had previously announced in November 2008. The trial met its primary endpoint with fidaxomicin achieving clinical cure compared to Vancocin(R). In addition, patients treated with fidaxomicin experienced a re...
...today announced that the MDX-1100 Phase 2 proof-of-concept trial in patients with active rheumatoid arthritis (RA) receiving methotrexate successfully met its primary endpoint. The top-line results from the recently completed 70-patient multi-center, randomized, double-blind, placebo-controlled Phase 2 t...
Autism Studies Presented at Mid-Atlantic Research Consortium Meeting
...Mid-Atlantic Research Consortium (MAC) of the federally sponsored Intellectual and Developmental Disabilities Research Centers (IDDRC). The consortium met on April 27 to focus on autism studies. The Children's Hospital of Philadelphia hosted the full-day research symposium, which brought together scienti...BioCryst Provides Peramivir Update and Reports First Quarter 2009 Financial Results
...nd 600 mg. i.v. peramivir for the treatment of seasonal influenza in the outpatient setting. The Phase 2 study, which was also sponsored by Shionogi, met its primary endpoint of time to alleviation of symptoms for both the 300 mg dose (p=0.0046) and 600 mg dose (p=0.0046). Forodesin...FDA Approves Vanda Pharmaceuticals' Fanapt(TM) for the Treatment of Schizophrenia
...pt(TM) for the treatment of schizophrenia was supported by two placebo-controlled short-term (4- and 6-week) trials. Both trials enrolled patients who met the DSM-III/IV criteria for schizophrenia, and Fanapt(TM) was shown to be superior to placebo in controlling symptoms of schizophrenia across doses of......ered to patients within 96 hours of an Acute Coronary Syndrome (ACS) event, met its primary endpoint of a reduction in Low Density Lipoprotein Cholesterol ...y and several secondary endpoints, clinical data from the FRANCIS study has met and/or exceeded our expectations and we hope to present the entire data set...
Pharmaxis Announces Positive Results of Phase 3 Cystic Fibrosis Trial
...ured by a change in Forced Expiratory Volume in 1 second (FEV1) when administered 400 mg twice per day for six months. The clinical trial comfortably met this endpoint. Patients treated with Bronchitol had a statistically significant improvement in lung function from baseline of 6.6% (p=0.001 versus pla...Other TagsSinusitisSpasmSpeechOther Contentsplaqueplaqueplaqueplaqueplaqueplaqueplaqueplaqueplastidplateauplateauplateauplateletsplateletsplateletsplateletsplateletspleiotropypleurapleura
SimianSinusitisSjogrenSlippedSnakebiteSolderSneezeSneezingSomatizationSpasmSpasmodicSpasticitySphygmomanometerSpeech
(Date:12/14/2009)... of Alberta researchers are part of an international team ... fossilized bones, to revise the history of North America,s ... U of A Earth and Atmospheric Sciences professor Duane ... based on radiocarbon dating of bones and teeth. That ... mammals in North America (the ,megafauna,) disappeared about 13,000 ...
(Date:12/14/2009)... clean-burning, renewable fuel that could help wean the nation ... ozone, compared with gasoline, especially in winter, according to ... Ozone production from both gasoline and E85, a blend ... is greater in warm sunny weather than during the ... and sunlight contribute to ozone formation. But E85 produces ...
(Date:12/14/2009)... study to date of the proteins in a species ... clues to how similar regeneration could be induced in ... at Indiana University-Purdue University Indianapolis and colleagues investigated over ... a type of salamander that has the unique natural ... with the hope that this knowledge will contribute to ...
Breaking Biology News(10 mins):Ethanol-powered vehicles generate more ozone than gas-powered ones 2Ethanol-powered vehicles generate more ozone than gas-powered ones 3IUPUI researchers tackle protein mechanisms behind limb regeneration 2Whats for Dinner 3F Brain Chemical Helps People Decide 61250 1Whats for Dinner 3F Brain Chemical Helps People Decide 61250 2Coffee break 3A Compound brewing new research in colon breast cancer 61247 1Coffee break 3A Compound brewing new research in colon breast cancer 61247 2Coffee break 3A Compound brewing new research in colon breast cancer 61247 3Coffee break 3A Compound brewing new research in colon breast cancer 61247 4Coffee break 3A Compound brewing new research in colon breast cancer 61247 5Coffee break 3A Compound brewing new research in colon breast cancer 61247 6Mechanical ventilation for patients with lung damage dont always work as planned 61244 1Mechanical ventilation for patients with lung damage dont always work as planned 61244 2Mechanical ventilation for patients with lung damage dont always work as planned 61244 3(Date:12/15/2009)... today launches SafeConsole 4.0, the web management software for SafeStick, ... provide better usability for employees and more control for administrators ... options. , ... Washington, DC (PRWEB) ... provider of secure USB devices, today launches SafeConsole 4.0, the ...
(Date:12/15/2009)... cardiovascular event, suicide goes up within a week ... 15 (HealthDay News) -- Emotional stress can put ... for cardiovascular events and suicide, a new study ... Swedish men diagnosed with prostate cancer between 1961 ... experienced a cardiovascular event within a year of ...
(Date:12/15/2009)... proud to announce the addition of David Tokofsky to ... Director of Development in the State of California and ... ,, David Tokofsky was elected to the Los ... 1995. As the Board Member for District Five, he ... Los Angeles through East Los Angeles to the Southeast ...
(Date:12/15/2009)... LEXINGTON, Ky., Dec. 15 Virtual Health ... that VHGI Gold (a wholly owned operating subsidiary ... to the VHGI advisory board to assist with ... properties into production as quickly as possible. Additionally, ... parties that they intend to schedule a Live ...
(Date:12/15/2009)... Dec. 15 Reportlinker.com announces ... is available in its catalogue: ,, ... Diseases Therapeutics - Market Forecasts to ... Deals Analysis ,, ... ,, The author has released its ...
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