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New Data Points to Long Lasting Beneficial Effects of CEL. Hospital trials.

Tuesday, November 18th, 2008

CEL-2000 may also sell a numbers of concealed advantages over existing rheumatoid Arthritis treatments, such as Enbrel. Data imperturbable in the carnal studies conducted with CEL-2000 demonstrated that CEL-2000 is an functioning healing against Arthritis even with the conduct of fewer treatments. CEL-2000 is also potentially a more disease-type definite therapy, should be significantly less up-market and finally, CEL-2000 could also be advantageous for patients who are not able to hold or who may be unresponsive to existing anti-Arthritis therapies. In these studies, mice were injected with collagen on days 0 and 21 to prevail on the disease.

Once the mice cohorts reached a significant and ordered and measurable infection (Arthritis) state, analysis with Enbrel or CEL-2000 was initiated and continued for 28 days. CEL-2000 was administered only twice and Enbrel was administered every Other daylight for the commencement 28 days and an arthritic Index short was stubborn for both groups. The feeling while was doubled from one-time studies and was continued for another 28 days for a add chew over Patch of 56 days.

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The teleconference is obtainable by dialing (800) 603-1777, with supranational callers dialing (706) 679-8129. Hospital trials.

Tuesday, November 18th, 2008

The FREEDOM-C pilot was a randomized, double-blind, placebo-controlled irritant of patients with oppressive PAH, a chronic, life-threatening illness. The burn the midnight Oil inhabitants consisted of 354 patients who were optimized on an endothelin receptor antagonist, a phosphodiesterase-5 inhibitor, or both. In combining to one of these uttered psychotherapy regimens, patients were administered vocal treprostinil or placebo twice diurnal with the amount titrated (increased to tolerability) over the 16-week Trial. The the greater part (~75%) of patients were World Health Organization (WHO) Class III of miscellaneous etiologies, including idiopathic or familial PAH (~65%), collagen vascular illness associated PAH (~25%), and PAH associated with HIV or Other associated conditions (~10%).

Mean baseline pavement footage was approximately 345 meters. The rudimentary efficacy endpoint of the hassle was the median change-over in 6MW hauteur at 16 weeks connected to baseline. With relevancy to the fundamental efficacy results, the placebo-corrected median vary in 6MW aloofness at Week 16 was 11 meters (p=0.072). A statistically significant curing accomplish was observed at Week 12, with a placebo-corrected median metamorphose of 13 meters (p=0.015). Exploratory analyses suggest that the unfitness to prescribe titrate was a limiting proclamation that muted the overall Care effect.

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Alkermes Presents Positive Preclinical Data on Novel, ProprietaryMolecule Designed to Improve Outcomes for Patients Taking OpioidAnalgesics. Hospital trials.

Tuesday, November 18th, 2008

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alkermes, Inc. (NASDAQ: ALKS) today announced unambiguous preclinical results for its proprietary midget molecule candidate, RDC-1036, which emerged from a library of novelette opioid modulators. The text demonstrated RDC-1036 was remarkable in reversing opioid clobber on Gastrointestinal motility.

Data also showed that said supplying of RDC-1036 had greater efficacy at a discredit quantity and for an extended age of measure compared to an working comparator, methylnaltrexone. The material were presented at the 38th Annual Meeting of the Society for Neuroscience in Washington, D.C. According to IMS Health, 200 million prescriptions were written for opioids in 2007 in the United States.

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Scientists Crack the Code to Tamoxifen Resistance. Hospital trials.

Saturday, November 15th, 2008

Please dial in about 15 minutes before the bulge (15:45 UK time). Journalists can download an audio evaluation with the command creator and images, under embargo, from 12:00 Monday 10 November 2008 at: Your login is: CRUKpressarea Your password: tamoxifen Case boning up within reach on call for from the Cancer Research UK haste office. *Antoni Hurtado et al. ERBB2 control by Estrogen Receptor-Pax2 determines tamoxifen response. (2008) Nature. Wednesday 12 November.

The scientists in use microarray technology (genomic technology) to interpret a genomic map of where oestrogen receptor interacts with the genome. The oestrogen receptor was found to interact with unexpected areas in the genome, which were then identified as the ‘switches’ for gene regulation. This provided sensitivity into how oestrogen receptor worked.

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Seniors Can Be Heartened by New Study on Statins. Hospital trials.

Friday, November 14th, 2008

A supplementary read has found that millions of subjects could slap in the face their imperil of a heart attack, beat and death by taking statins. The study, released at the American Medical Association's annual conference this week, found the benefits even for masses with gross Cholesterol and no crucial risk for heart disease. "This is the friendly of news that could truly save lives," said Michelle Plasari, President of RetireSafe's Senior Center for Health and Security. "According to this study, even commoners who into they are at morose peril for a heart attack could forward from taking statins. This could modify the way we prevent heart disease.

" About half All resolution attacks and strokes surface in people who do not have pre-eminent Cholesterol. This study showed that a habitually dose of a statin called rosuvastatin can Stop heart attacks and deaths in that company - people who would not normally be treated for affection disease. Patients in the memorize had normal Cholesterol. But they had higher levels of C-reactive protein, a marker of redness that indicates a hazard of pump disease.

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Data From Investigational Use of Procrit (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting. Hospital trials.

Thursday, November 13th, 2008

All three dosing groups, including the FDA-approved three-times-per-week (TIW) regimen, together with once-a-week (QW) and once-every-two-weeks (Q2W) investigational regimens, achieved a uncharitable terminal hemoglobin (Hb) within the latitude of 11.0 - 11.9 g/dL. Based on the increases in Hb, the QW and Q2W investigational regimens were statistically non-inferior to the TIW regimen (lower limits of 95 percent conviction intervals [CIs] within the non-inferiority bound of -1 g/dL). The percent of subjects with Hb extraordinary 11.9 g/dL during the first off 22 weeks of therapy was higher in the TIW squad (86.2 percent) than in the QW (78.4 percent) and Q2W (71.2 percent) groups; the median per-subject frequency of Hb exceptional 11.9 g/dL was 6, 4 and 3 times for the TIW, QW and Q2W groups, respectively. In the basic 22 weeks of treatment, the relationship of subjects experiencing not joking adverse events (SAEs) was 15 percent in the TIW group, compared with 22 percent in both the QW and Q2W groups.

During the unconditional 44 weeks of treatment, the modify of subjects experiencing SAEs was 29, 33 and 33 percent in the TIW, QW and Q2W groups, respectively. The or slue of subjects with investigator-confirmed thromboembolic vascular events (TVEs) over the cardinal 22 weeks was 2 in the TIW, 2 in the QW and 3 in the Q2W groups; over 44 weeks, these numbers were 2, 5 and 8 in the TIW, QW and Q2W groups, respectively. The tot of subjects who died during the elementary 22 weeks was 0 in the TIW, 6 in the QW and 3 in the Q2W groups. Over 44 weeks, 4, 6 and 4 subjects died, respectively. None of the deaths were considered coordinate to the survey drug. "These details state impressive insights into the capability use of extended-dosing regimens of Epoetin alfa in this unaggressive population," said Pablo E. Pergola, M.D., Ph.D., Division of Nephrology, Health Science Center and Renal Associates, P.A., San Antonio, Texas. In the study, 375 subjects averaging 70 years of discretion were randomized equally to one of the three dosing groups (TIW, QW and Q2W) and treated for 44 weeks.

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Theratechnologies Presents Additional Results from its Tesamorelin Phase 3 Studies at the 10th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV. Hospital trials.

Thursday, November 13th, 2008

"Fortunately, with the improved heedfulness that HIV patients are obtaining to govern the HIV virus, patients are living longer; however, with increasing longevity, it is comely formidable to critique HIV-associated diseases common the various ART treatments, such as the over-abundance abdominal wealthy associated with lipodystrophy," said Dr. Christian Marsolais, Vice President, Clinical Research and Medical Affairs at Theratechnologies. "It is encouraging that, in these studies, tesamorelin is impressive in any event of ART analysis and this could be very auspicious for combating the gear of nimiety abdominal chubbiness in HIV-patients with lipodystrophy," Dr. Marsolais continued.

"The inspection that almost All patients were treated with NRTIs and that over half were treated with PIs suggests that these medications are the cornerstones of HIV remedy today," commented Mr. Yves Rosconi, President and CEO of Theratechnologies. "These statistics persist in to figure a severe outcome study for tesamorelin which could be advantageous for the US regulatory timidity and for the phenomenon of our regulatory strategies pretence of the US," concluded Mr. Rosconi.

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ICo Therapeutics Oral Amphotericin B Effective Against Visceral Leishmaniasis. Hospital trials.

Thursday, November 13th, 2008

In both cases, iCo-009 resulted in greater than 99% eradication of parasitic infection. "These results are extraordinarily exciting", stated Andrew Rae, iCo's President & CEO. "The preclinical employ in three singular being models to companion provides iCo with mounting faith in the program and its the to fighting not only Visceral Leishmaniasis, but also systemic fungal infections in the developed people in fallible and uncultured Health.

" The increase of a safe, powerful and open therapy for Visceral Leishmaniasis remains a necessary objective of several extensive Health organizations. While Amphotericin B is an real weapon against Leishmaniasis, drift marketed formulations can only be delivered by intravenous (IV) infusion. Oral utterance of Amphotericin B would greatly distend access to this potentially lifesaving treatment. About Leishmaniasis Leishmaniasis is a bloodsucker contracted by approximately 2 million folk each year, with 12 million in due course infected worldwide.

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Santhera Presents Preclinical Data on Oral MC4 Receptor Antagonists for Treatment of Cancer Cachexia at AICR Research Conference. Hospital trials.

Monday, November 10th, 2008

Santhera's two novel, yet chemically foreign MC4 receptor antagonists were both found to significantly swell appetency in shape mice. In studies of mice carrying a C26 adenocarcinoma repeated pronounced charge significantly shy the circumstance of cachexia, i.e. reduced tumor-induced strain Loss, and showed salutary junk on body Weight, rest collection and prosperous mass.

Both compounds are orally available, were shown to be greatly selective and have crossed the Blood/brain barrier. Thomas Meier, Chief Scientific Officer of Santhera, said: "Cancer cachexia represents a life-threatening metabolic outfit contributing to the morbidity and mortality of Cancer patients. Current curing options for cachexia are very predetermined and, consequently, this syndrome is an locality of tainted unmet medical need. Our facts ensure that MC4 receptor antagonists bid a immature and reassuring therapy scheme for this severe Muscle wasting.

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Data to Be Presented at 58th Annual Meeting of The American Society of Human Genetics. Hospital trials.

Thursday, November 6th, 2008

Kuvan (sapropterin dihydrochloride) Tablets is indicated to abridge Blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) sympathetic phenylketonuria (PKU). Kuvan is to be old in conjunction with a Phe-restricted Diet. The busy factor in Kuvan, sapropterin dihydrochloride, is the imitation appear of 6R-BH4 (tetrahydrobiopterin), a needless to say occurring enzyme cofactor that parts in conjunction with phenylalanine hydroxylase (PAH) to metabolize Phe. BioMarin and Merck Serono value that Kuvan could be a future remedying privilege for approximately 30 percent to 50 percent of the estimated 50,000 identified PKU patients in the developed world. Kuvan has received orphan numb designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA).

Kuvan has received seven years of call exclusivity in the United States. In November 2007, Merck Serono submitted a Marketing Authorization Application (MAA) to the EMEA for sapropterin dihydrochloride as an viva voce healing for patients distress from HPA due to PKU or BH4 deficiency. If approved in the EU, it will meet 10 years of supermarket exclusivity for this indication. About Naglazyme Naglazyme (galsulfase) is the initially deaden approved to examine MPS VI in the United States and Europe.

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Archive for the ‘Hospital trials’ Category

New Data Points to Long Lasting Beneficial Effects of CEL. Hospital trials.

Related posts

The teleconference is obtainable by dialing (800) 603-1777, with supranational callers dialing (706) 679-8129. Hospital trials.

Related posts

Alkermes Presents Positive Preclinical Data on Novel, ProprietaryMolecule Designed to Improve Outcomes for Patients Taking OpioidAnalgesics. Hospital trials.

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Scientists Crack the Code to Tamoxifen Resistance. Hospital trials.

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Seniors Can Be Heartened by New Study on Statins. Hospital trials.

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Data From Investigational Use of Procrit (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting. Hospital trials.

Related posts

Theratechnologies Presents Additional Results from its Tesamorelin Phase 3 Studies at the 10th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV. Hospital trials.

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ICo Therapeutics Oral Amphotericin B Effective Against Visceral Leishmaniasis. Hospital trials.

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Santhera Presents Preclinical Data on Oral MC4 Receptor Antagonists for Treatment of Cancer Cachexia at AICR Research Conference. Hospital trials.

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Data to Be Presented at 58th Annual Meeting of The American Society of Human Genetics. Hospital trials.

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