CSL shares went for a run Tuesday, jumping $1 (adding $183 million to the value of the company), before fading to end the day square, and then continued lower yesterday.
The shares fell 86c to end at $83.20 yesterday after the strong start on Tuesday which tapered off after a briefing Tuesday afternoon failed to enthuse health care analysts.
The reason for the jump was a press release from the company which suggested the company may have a new drug with the ability to raise the level of so called good cholesterol in the blood, while reducing the volume of plaque in coronary arteries.
Sounds like a sort of medical marvel.
Here’s part of what CSL said in the release;
“SL Limited today announced results from a study published in the Journal of the American Medical Association that suggest infusions of a novel new drug, CSL-111, to acutely raise HDL (“good” cholesterol) levels, may reduce the amount of plaque in the coronary arteries of patients with a recent episode of acute coronary syndrome (ACS).
“CSL advised that the Effect of Reconstituted HDL on Atherosclerosis – Safety and Efficacy (ERASE) trial was a phase 2, randomized, blinded, placebo-controlled study conducted at 17 sites throughout Canada and coordinated by the Montreal Heart Institute.
“The trial examined whether 4 infusions of CSL-111, given at weekly intervals to patients with a recent episode of ACS, could reduce the volume of plaque in the coronary arteries.
“Assessment of the arteries was performed using intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) before and 2-3 weeks after the treatment. IVUS is a technique in which a tiny ultrasound probe is inserted into the coronary arteries to determine the change in plaque during treatment. Coronary angiography is an X-ray examination of the blood vessels.”
Dr Andrew Cuthbertson, CSL’s Chief Scientific Officer, advised that 183 patients had received placebo (n=60), 40 mg/kg (n=111) or 80 mg/kg (n=12) of CSL-111. He noted that the higher dosage of CSL-111 was discontinued early because of transient liver function test abnormalities, but the 40mg/kg dose was safe and generally well tolerated.
“CSL confirmed that the results were based on data from 145 patients who had 2 sequential IVUS procedures. The main findings were that there was a reduction in coronary plaque volume after infusions of CSL-111 of 3.4 percent and after placebo of 1.6 percent, which were not statistically significantly different. However, when compared to baseline, the reduction for patients infused with CSL-111 was statistically significant (p< 0.001), but this was not the case in the placebo group.
“Other assessments of the plaque, such as characterization indexes or changes in plaque that are different than volume measurements, on IVUS and coronary score on QCA, were significantly different between CSL-111 and placebo. Interestingly, the difference in coronary score between patients that had 4 weeks of CSL-111 and those given placebo was similar to those observed after two years of statin treatment (compared with no statin).
“Overall, these results strongly suggest that CSL-111 is biologically active, and that short term infusions of CSL-111 result in a rapid, favourable effect on coronary atherosclerotic plaque,” said Dr. Tardif, Principal Investigator, Montreal Heart Institute.
So if it sounds as promising as that sounds, why did CSL shares retreat and continue easing yesterday? Perhaps it was this report from the US website Marketwatch.
“A new study of a cholesterol drug recently abandoned by Pfizer doesn’t answer the question of why the compound failed or whether similar experimental drugs will be successful.
“The lack of efficacy may be related to the mechanism of this drug class or to molecule-specific adverse events,” says the Pfizer-sponsored research that was unveiled at the annual meeting of the American College of Cardiology.
“The drug is torcetrapib, which Pfizer had hoped would be the successor to Lipitor, the world’s best-selling drug and a contributor of $US3.3 billion 27 per cent last year’s corporate revenue of $US12.9 billion.
“But Pfizer cancelled work on the drug last December after the company said a clinical trial showed that patients receiving torcetrapib plus Lipitor had a higher-than-expected death rate than patients receiving Lipitor alone.
“Pfizer executives were hard-pressed to explain what happened in the 15,000-patient test, whose full results won’t be available until later this year. Monday’s results of another clinical trial of nearly 1,200 patients only offered possible scenarios.
“The latest research found that torcetrapib plus Lipitor failed to significantly reduce the buildup of artery-clogging plaque when compared with Lipitor alone. Patients were tested for 24 months.
“As in the larger clinical trial, researchers found that torcetrapib raised patients’ blood pressure, lowered so-called bad cholesterol and raised good cholesterol. The research was posted online by The New England Journal of Medicine, in advance of publication in its March 29 issue.”
“The study’s authors also told companies working on similar drugs, known as CETP inhibitors, that the Pfizer experience doesn’t automatically translate into bad news for their research efforts.
“Given the potential importance of finding new drugs to raise good cholesterol levels, it would seem imprudent to abandon studies of CETP inhibition,” especially because similar drugs don’t appear to raise blood pressure.
“Merck and Switzerland’s Roche are developing CETP inhibitors, and they are in the process of deciding whether to move from midstage clinical testing to the third round of human tests.
“Phase III testing is the most extensive and expensive clinical trial, and it represents the last clinical research before a drug is submitted to regulators.
“CE
