UPDATED: New cloud hovers over class of ‘good cholesterol’ drugs

Posted under Blog, cholesterol, Companies, CTEP inhibitors, Diagnostics, Eli Lilly, Funding, HDL, heart disease, heart drug, John LaMattina, Medical Devices, Medical Supply, Merck, Pharmaceuticals, Pipeline, Startups, Universities, Videos by Ryan McBride

Fresh doubts have cropped up for raising "good cholesterol" to combat heart attack risk, after a new study showed that patients genetically programmed to have higher levels of HDL cholesterol didn't appear to be more protected from heart disease than those with low levels. The news comes as Merck ($MRK) and Eli Lilly ($LLY) are spending millions of dollars to develop HDL-raising treatments, aiming to deliver on the blockbuster potential of the CETP drug class.

"I'd say the HDL hypothesis is on the ropes right now," said outside observer Dr. James A. de Lemos, a professor at the University of Texas Southwestern Medical Center, as quoted by The New York Times.

The HDL mechanism took a recent blow last week when Swiss drug giant Roche ($RHHBY) announced that it was nixing development of its contender designed to raise good cholesterol to thwart heart disease because of absent efficacy, following previous failures at Pfizer ($PFE) and Abbott ($ABT). Informed of the new genetic study revealed this week in The Lancet, Merck and Lilly representatives told the Times that the companies were both undeterred and continuing with their massive CETP programs. Yet the findings have dampened expectations for the drugs.

"This will have a sobering effect, it would have to," said John LaMattina, a senior partner at PureTech Ventures and former Pfizer R&D chief, as quoted by Bloomberg. "HDL has always been a controversial area. You have a question that you have to be willing to commit over a billion dollars in order to get the answer, and that is a very daunting commitment."

With billions of dollars in development costs and potential revenues on the line, expect scientists inside and outside of biopharma companies to take heed of the findings and dig deeper into the role of HDL in heart disease. As the Times notes, mouse studies showed that HDL carried cholesterol out of the arteries. But scientists will now look into whether HDL is an indicator or driver of reduced heart-attack risk.

Forbes' Matthew Herper reported that the latest HDL paper might not bring much in the way of new doubt about HDL-raising drugs, which were "already on the ropes" because of conclusions from previous studies. And he noted that The Lancet paper shows a slight 4% reduction in heart attack risk among patients with a mutation to the CETP gene, which might give hope to believers in drugs that target the CETP protein.

- read the NYT's article
- and Bloomberg's report
- see Herper's piece

Related Articles:
Roche abandons potential blockbuster cholesterol drug
Developers spotlight huge potential of new class of cholesterol drugs
Lilly heralds PhII success for mega-blockbuster cholesterol drug contender

Editor's note: Adds analysis of The Lancet paper from Herper's article. 05/20/12.

Pozen shares jump on promising outcome for PhIII studies

Posted under Blog, Companies, Diagnostics, Funding, heart disease, Medical Devices, Medical Supply, Pharmaceuticals, Pozen, Startups, Universities, Videos by John Carroll

Pozen ($POZN) shares took a big bounce this morning after the developer said it reaped positive data from a pair of late-stage studies on an amped-up aspirin for heart disease patients, putting it on the road to an NDA later in the year. Its stock surged 19% in early trading today.

Chapel Hill, NC-based Pozen recruited more than 1,000 patients for the late-stage studies of PA32540, a combination of immediate-release omeprazole and a 325 mg dose of delayed-release aspirin. The primary goal was a reduction of aspirin-associated ulcers among high-risk patients taking aspirin to prevent a cardiovascular event. The studies also met key secondary endpoints, including a reduction "in gastroduodenal ulceration as well as a reduction in discontinuation due to upper gastrointestinal adverse events in subjects."

"This information is essential to progress our PA32540 partnership discussions for the United States, and to allow us to continue to move forward with our preparations for a third-quarter NDA submission for this product candidate," said Pozen CEO John R. Plachetka. The company's release omitted any data, which will be released at a scientific meeting later in the year.

Last fall, Pozen sold its U.S. royalty rights in Treximet, a migraine drug, to a pension fund for $75 million. Treximet had accounted for 80% of its annual revenue. 

- here's the release
- here's the story from The News & Observer

​Related Articles:
Pozen poised for profits after Vimovo wins approval
Pozen touts positive data on new arthritis therapy
Treatment gap: Women get fewer standard heart drugs

Pioneering stem cell therapy mends damaged heart tissue in patients

Posted under Advanced Cell Technology, Blog, Capricor, Companies, Diagnostics, Funding, heart disease, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Stem Cell Therapeutics, Universities, Videos by Ryan McBride

Score one small victory for the troubled field of stem cell therapeutics. A small clinical trial showed that patients' own stem cells could repair damaged heart tissue after they suffered heart attacks, giving California developer Capricor the confidence to push ahead with a larger study, Bloomberg reported.

With an eye toward combating heart failure, 17 patients got the stem cell treatment, and half of what would otherwise be permanent scarring was fixed and muscle tissue grew. There was no significant change in heart function between those who got the experimental stem cell treatment and those who got the standard therapy in the 25-patient trial, but the regeneration of heart tissue marks significant progress in the field, experts told Bloomberg.

"If we can regenerate the whole heart, then the patient would be completely normal," Eduardo Marban, the study's lead author from Cedars-Sinai Heart Institute in Los Angeles, told Bloomberg. "We haven't fulfilled that yet, but we've gotten rid of half of the injury, and that's a good start."

Of course, this stem cell therapy faces a long haul to prove its worth as a treatment for patients at risk of heart failure--which has long been the leading cause of death among Americans. But the promise shown in the trial conducted at Cedars-Sinai and Johns Hopkins University boosts a stem cell field that has taken some blows recently, most notability with embryonic stem cell pioneer Geron's ($GERN) decision to exit the field and sell its ESC assets last year.

Capricor's good news adds to Advanced Cell Technology's ($ACTC) upbeat data from a study of an ESC therapy for combating blindness. So these developers and their never-say-die mentality keep the world watching the stem cell field.

- check out Bloomberg's article
- see The Telegraph's report

Related Articles:
Fetal stem cells from placenta could be heart treatment breakthrough
ACT trumpets positive efficacy data from ESC trial sampling
Geron abandons pioneering stem cell program, lays off 66