Medivir AB (sto:MVIRB)(omx:MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announces the start of a phase Ib clinical trial with TMC649128 intended for the treatment of chronic hepatitis C virus (HCV) infection.
TMC649128 is a nucleoside NS5B polymerase inhibitor developed in collaboration with Tibotec Pharmaceuticals. TMC649128 has demonstrated an attractive pre-clinical profile and displays in vitro activity across multiple HCV genotypes and a high genetic barrier to resistance. A clinical phase Ia double-blind, randomized, placebo-controlled single-ascending dose trial to assess the safety, tolerability and pharmacokinetics in healthy volunteers has now successfully been completed.
The TMC649128 phase Ib study that now is underway is a double-blind, randomized and placebo-controlled trial in genotype 1 HCV-infected patients to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of multiple ascending doses of TMC649128 given as monotherapy and in combination with pegylated interferon and ribavirin.
It is anticipated that TMC649128 will be used in combination with other HCV direct acting antiviral agents, given its high genetic barrier to resistance and antiviral activity across multiple HCV genotypes.
"We are delighted to see TMC649128, our first HCV nucleoside inhibitor, advance into clinical phase Ib studies in HCV patients", stated Bertil Samuelsson, CSO of Medivir. "The start of this phase Ib trial underscores our commitment to develop new and innovative treatments for hepatitis C infected patients. We view nucleoside inhibitors, such as TMC649128, and protease inhibitors, such as TMC435, as cornerstone components of future direct acting antiviral combinations for HCV therapy."
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
About Medivir's Commitment to HCV
Medivir and Tibotec are also jointly developing the once daily protease inhibitor TMC435 for treatment of hepatitis C virus infections (HCV).
About Medivir
Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development. Medivir has a strong R&D portfolio and has recently launched its first product Xerese(TM)/Xerclear(R). Medivir's key pipeline asset, TMC435, a protease inhibitor, is in global phase 3 clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.
2011年6月22日星期三
2011年4月23日星期六
Rolen shelved by sore shoulder
Reds third baseman Scott Rolen is still dealing with a sore left shoulder. How long he’ll be out of the lineup is the question. He was out Friday night for the series opener against the St. Louis Cardinals. “It’s the day-to-day thing,” Reds manager Dusty Baker said. “I told him to 'let me know where you are without me really pressuring you about it.' Anybody who’s ever had anything wrong, the question you hate to hear is the how-do-you-feel question. Usually, you don’t feel a whole bunch better one day to the next.”
Rolen doesn’t know when he’ll return. Could he play this weekend?
“Anything’s feasible,” he said.
The matter is made worse for the Reds by the fact Juan Francisco, Rolen’s backup at third, is on the disabled list.
“This was supposed to be Francisco’s time,” Baker said. “It’s a terrible series of events.”
Last year, Rolen missed nine games with a sore right hamstring but never went on the DL. Have the Reds thought about putting him on the DL to give the shoulder two weeks to heal?
“There’s that thought,” Baker said. “But it’s too early to think that. It’s only been two days. Last time, we waited as long as we could and it worked out. If you get him for four days rather than lose him for two weeks ... it’s a delicate balance. We’re not there yet. We’ll see what treatment does.”
The shoulder led to back and neck pain as well. Rolen saw Dr. Tim Kremchek after the game Thursday and again Friday morning. He was given two cortisone injections.
An MRI of his neck checked out OK.
“I tracked it back to San Diego,” Rolen said. “I don’t know if you guys have noticed, but I haven’t been excelling. I’m not pointing fingers but I’ve been struggling a bit with my shoulder for seven to 10 days.”
Rolen, 35, was 4-for-29 the previous eight games with two RBI and was batting .217 overall with two homers and 12 RBI.
“It's got to be a neck and back thing -- the same thing as last year,” Rolen said. “The shoulder started bothering me a little bit. I didn’t pay much attention to it at first. When that happens to me, I normally go to the mirror and video in the batting cage. I was trying to get over the hump. It gets to a certain point where you start going in the wrong direction.
“I’m trying to figure out how to catch up to 87, 88. Wait a minute. I’m trying to figure out how to finish the game. These are the thoughts in my mind. It was going the wrong way.”
Generally, it takes Rolen two or three days to get relief from the cortisone injection.
He was more sore Friday than Thursday. But the injections have taken care of the problem in the past. That’s why he wanted to take care of it now.
“Let’s hit this right now, whatever it is,” he said. “Let’s not have this drag into June and July.”
Baker was hoping to get Rolen to June and July healthy.
“Like I said in beginning of the year, I was trying to get Scottie to the hot weather,” Baker said. “The hot weather seems to help. This has been a very cold, damp spring which doesn’t lend itself to lubricating your rusty joints.”
Rolen had surgery on the shoulder in 2005. He’s dealt with it since.
“I’ve made changes to keep stress off it,” he said. “Definitely, it’s affected me. I don’t know if bothered is right word. I was on the field all last year.”
Rolen, for example, has held his hands lower in batting stance.
“I know if I look at the video, I’ll see my hands creeping up,” he said. “I’ve got to be a little more conscious of it. I went two years in Toronto and last year until a single swing in September (and) here we go again. There were two full years where it was working.
“I’ve got to pay attention to it. I’ve got to address now. I’ve got shoulder, neck and back ... It’s neck and back because of the shoulder. Knock the shoulder out, does that take care of the neck and back situation?”
Whether or not he plays, Rolen anticipated no lingering resentment between the teams from last year’s brawl in early August in Cincinnati.
“I hope it’s baseball on the field, I hope that’s where the rivalry is,” Rolen said. “I hope the rivalry is two teams that hopefully are going to be at the top of the division and fighting down the stretch for the National League Central.
“We have a good ballclub and I think they do over there.”
Cardinals center fielder Colby Rasmus also expected the focus to be on the game.
“I see them as another team that I’m just trying to go out and beat,” Rasmus said. “I don’t see them as a bitter rival, I’ve got some friends on the team.”
Rolen doesn’t know when he’ll return. Could he play this weekend?
“Anything’s feasible,” he said.
The matter is made worse for the Reds by the fact Juan Francisco, Rolen’s backup at third, is on the disabled list.
“This was supposed to be Francisco’s time,” Baker said. “It’s a terrible series of events.”
Last year, Rolen missed nine games with a sore right hamstring but never went on the DL. Have the Reds thought about putting him on the DL to give the shoulder two weeks to heal?
“There’s that thought,” Baker said. “But it’s too early to think that. It’s only been two days. Last time, we waited as long as we could and it worked out. If you get him for four days rather than lose him for two weeks ... it’s a delicate balance. We’re not there yet. We’ll see what treatment does.”
The shoulder led to back and neck pain as well. Rolen saw Dr. Tim Kremchek after the game Thursday and again Friday morning. He was given two cortisone injections.
An MRI of his neck checked out OK.
“I tracked it back to San Diego,” Rolen said. “I don’t know if you guys have noticed, but I haven’t been excelling. I’m not pointing fingers but I’ve been struggling a bit with my shoulder for seven to 10 days.”
Rolen, 35, was 4-for-29 the previous eight games with two RBI and was batting .217 overall with two homers and 12 RBI.
“It's got to be a neck and back thing -- the same thing as last year,” Rolen said. “The shoulder started bothering me a little bit. I didn’t pay much attention to it at first. When that happens to me, I normally go to the mirror and video in the batting cage. I was trying to get over the hump. It gets to a certain point where you start going in the wrong direction.
“I’m trying to figure out how to catch up to 87, 88. Wait a minute. I’m trying to figure out how to finish the game. These are the thoughts in my mind. It was going the wrong way.”
Generally, it takes Rolen two or three days to get relief from the cortisone injection.
He was more sore Friday than Thursday. But the injections have taken care of the problem in the past. That’s why he wanted to take care of it now.
“Let’s hit this right now, whatever it is,” he said. “Let’s not have this drag into June and July.”
Baker was hoping to get Rolen to June and July healthy.
“Like I said in beginning of the year, I was trying to get Scottie to the hot weather,” Baker said. “The hot weather seems to help. This has been a very cold, damp spring which doesn’t lend itself to lubricating your rusty joints.”
Rolen had surgery on the shoulder in 2005. He’s dealt with it since.
“I’ve made changes to keep stress off it,” he said. “Definitely, it’s affected me. I don’t know if bothered is right word. I was on the field all last year.”
Rolen, for example, has held his hands lower in batting stance.
“I know if I look at the video, I’ll see my hands creeping up,” he said. “I’ve got to be a little more conscious of it. I went two years in Toronto and last year until a single swing in September (and) here we go again. There were two full years where it was working.
“I’ve got to pay attention to it. I’ve got to address now. I’ve got shoulder, neck and back ... It’s neck and back because of the shoulder. Knock the shoulder out, does that take care of the neck and back situation?”
Whether or not he plays, Rolen anticipated no lingering resentment between the teams from last year’s brawl in early August in Cincinnati.
“I hope it’s baseball on the field, I hope that’s where the rivalry is,” Rolen said. “I hope the rivalry is two teams that hopefully are going to be at the top of the division and fighting down the stretch for the National League Central.
“We have a good ballclub and I think they do over there.”
Cardinals center fielder Colby Rasmus also expected the focus to be on the game.
“I see them as another team that I’m just trying to go out and beat,” Rasmus said. “I don’t see them as a bitter rival, I’ve got some friends on the team.”
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