�ARYx Therapeutics, Inc., (NASDAQ:ARYX), a biopharmaceutical company, announced the results of a Phase 2b clinical trial testing the safety and efficacy of its prokinetic agent, ATI-7505, in patients with chronic idiopathic impairment. The clinical trial, conducted by Procter and Gamble Pharmaceuticals (P&G), was designed to enrol 400 patients evaluating quatern doses of the agent compared to placebo. As announced last month, the study was terminated other after exclusively 214 patients had been enrolled, as a solution of the termination of the collaboration between ARYx and P&G.
"In nastiness of the early expiry of the study, ATI-7505 achieved statistical significance at the study's primary terminus in the 80 mg twice daily dose. In addition, all doses tested demonstrated a clinically meaningful increase in spontaneous intestine movements over baseline compared to placebo after unitary week of treatment," said Dr. Paul Goddard, Chief Executive Officer and Chairman of ARYx. "From a tolerability linear perspective, ATI-7505 improved patients' ability to see spontaneous gut movements with virtually no reports of diarrhea or nausea from the patients in this trial."
The clinical trial was a Phase 2b, randomized, placebo-controlled study of ATI-7505 in patients with chronic idiopathic constipation conducted at 42 trial sites in 5 countries. Patients were treated for 4 weeks and the primary efficacy end point was the improvement in the tote up number of spontaneous gut movements (SBM) during the first 7 days after randomization compared to placebo. Patients were randomized to either placebo or doses of ATI-7505 of 20 mg twice a mean solar day (bid), 40 mg press, 80 mg bid, or 120 mg bid. Randomization was balanced amongst all treatment blazonry. SBM was defined as a gut movement occurring without the need for a laxative or enema within the preceding 24 hours. Safety assessments were conducted on every patient enrolled.
Utilizing the original statistical analysis plan for the total study, statistical significance (p=0.0031) was achieved at the 80 mg tender dose with an increase of a mean of 3.32 SBMs in the first week compared to service line. In the placebo radical, this increment was only 0.31 SBMs. A preliminary analysis of the overall answerer rate indicates ATI-7505 kept up its prescribed effect over the full 4-week treatment period. In addition, time-to-first SBM using a Kaplan-Meier analysis suggests that many patients on ATI-7505, unlike placebo, sustain their first SBM following the number one dose of the drug and this effect was observed at all doses tested. The 80 mg bid dosage was very well tolerated and in that respect were no reports of diarrhea, nausea or emesis.
"As sweet as these results ar, particularly when coupled to the lately announced results of the Thorough QT study conducted on ATI-7505, ARYx remains committed to focusing our primary efforts on producing the clinical trial results necessary to partner our other deuce Phase 2 clinical candidates, our oral anticoagulant agent ATI-5923 and our oral anti-arrhythmic agent ATI-2042," continued Dr. Goddard. "While we will seek a new development mate for ATI-7505, our partnering efforts will remain focussed on maximizing the value of ATI-5923 and ATI-2042. In the meantime, we will carry on to analyse the results of this chronic impairment study so they whitethorn be presented to potential partners along with the rest of the material data supporting ATI-7505."
About ARYx Therapeutics, Inc.
ARYx Therapeutics is a biopharmaceutical company focussed on development a portfolio of internally discovered products designed to eliminate known safety issues associated with well-established, commercially successful drugs. ARYx uses its RetroMetabolic Drug Design� technology to design structurally unique molecules that retain the efficacy of these original drugs but are metabolized through a potentially safer pathway to avoid specific untoward side personal effects associated with these compounds. ARYx currently has quaternity products in clinical trials: an oral anticoagulant agent for patients at peril for the formation of dangerous blood clots, ATI-5923; an oral anti-arrhythmic agent for the treatment of atrial fibrillation, ATI-2042; a prokinetic agent for the treatment of various gastrointestinal disorders, ATI-7505; and, an agent for the treatment of schizophrenia and other psychiatric disorders, ATI-9242. Please visit our web site at wWW.aryx.com for extra information.
About ATI-7505
ATI-7505 is our product designed to normalize upper and lower gI motility to treat diverse GI disorders. A potent agonist of 5-HT4 receptors which survive throughout the GI tract regulating stomachic emptying and the motility of solid food through the intestines, ATI-7505 is engineered to maintain the efficaciousness of cisapride, a do drugs that reached peak sales of $1.0 gazillion a year prior to being recluse from the market in 2000 due to severe cardiac toxicities. However, unlike cisapride, ATI-7505 is non dependent upon a rate-limiting cytochrome P450 enzyme in the liver for metamorphosis and hence is designed to avoid the progress of drug levels associated with cisapride's toxicities. In addition, ATI-7505 is more than selective than cisapride having minimal activity on the hERG television channel in the heart and virtually no activity at the 5-HT3 or other serotonergic receptors. To rein.
ARYx Therapeutics, Inc.
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Wednesday, 3 September 2008
Wednesday, 6 August 2008
Dave Stewart and The Spiritual Cowboys
Artist: Dave Stewart and The Spiritual Cowboys
Genre(s):
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Discography:
Dave Stewart and The Spiritual Cowboys
Year: 1990
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Friday, 27 June 2008
Gary Dourdan: The Fat Man Cometh
Former "CSI" douche Gary Dourdan emerged thicker in L.A. on Wednesday, after copping to drug charges and hitting up rehab last month.Unfortunately, with his scarf-tie thingy, necklaces, rings, cuff, bracelet, watch and wallet chain, Dourdan is now guilty of possessing way too many damn accessories. Just say no, Gary.
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Genre(s):
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Tracks: 4
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Nomansland
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Friday, 13 June 2008
Temperatures Plummet Ahead Of Isle Of Wight Festival
A mixture of rain and sunny spells will greet festivalgoers heading to the Isle of Wight Festival this weekend.
Forecasters are predicting heavy showers tomorrow (June 13th), the first day of the festival, and a maximum temperature of 17 decrees Celsius.
Although the cool temperatures will remain, conditions are expected to brighten over the course of the weekend with sunny spells breaking up the rain showers.
As previously reported, this years Isle of Wight festival will feature headlining performances from Kaiser Chiefs, The Police and Sex Pistols.
Tickets for the festival have sold out. For all the latest information on all this year's festivals, check out our new look Festival Guide.
Are you going to the Isle of Wight Festival? If so, let Gigwise readers know your plans by posting a comment below. Sign up to see your thoughts appear automatically.
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Friday, 6 June 2008
50 Cent - 50 Cent Blaze Part Of Arson Spree
The arson attack on 50 CENT's New York home was part of a string of similar blazes, investigators suspect.
The rapper's Long Island mansion went up in smoke on Friday (30May08) while his ex-girlfriend Shaniqua Tompkins and his ten-year-old son Marquise were at home.
They escaped unhurt.
Tompkins claims the rapper was involved, but police are trying to establish a link to two other fires which started nearby less than an hour before.
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Saturday, 31 May 2008
American Idol - Father Of Idol Top-three Finalist Booted Out Of Rehearsals
Jeff Archuleta, the father of American Idol top-three finalist David Archuleta,
has been banned from attending rehearsals, published reports said Friday, citing
a person working for the show. The report, which originally appeared on the gossip
website TMZ.com, claimed that producers made their decision after Jeff Archuleta's decision
to change lyrics of a song his son performed Tuesday night resulted in the program's
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