OSIRIS AND IMCLONE
GOOD RESULTS AT WORK

Of all the announcements, besides Dendreon’s comments, news and assessments, nothing is interesting enough to be mentioned except Osiris’ (OSIR) news about its stem cell drug Provacel’s effect on the cardiac muscle post infarction. Also to be followed up on is Imclone’s (IMCL) news about the efficacy of the firm’s drug Erbitux’ on head and neck cancer. Other firms’ postings talk about joining meetings.

What puts Osiris in the spotlight is the firm’s success in developing drugs based on the use of adult stem cells to regenerate organ tissues. Recently, it announced encouraging results with its stem cell product Provacel on the heart post myocardial infarction. When a heart attack (coronary artery occlusion) causes myocardial infarction, an area of the heart muscle is deprived of blood and becomes scarred, losing muscle to a futile fibrous tissue that causes weakness of the heart, which could progress to heart failure.

It is this transformation from muscle to fibrous tissue that Osiris’ drug seems to prevent. Researchers have been trying to figure out ways to solve this problem by building new heart muscle with the use of stem cells. Patients who took Provacel were four times less likely to experience symptoms of infarction, including irregular heartbeats compared to those receiving a placebo. And 42% of the Provacel patients experienced improvement in their overall condition after six months compared to only 11% on the placebo.

The results are, indeed, encouraging. They indicate that adult stem cells are safe and cause a clinical improvement of patients who have suffered a heart attack. According to the firm, the magnitude of the across-the-board improvement was surprising and the data further validate the broad clinical applicability of the firm’s stem cell technology.

Imclone’s drug, Erbitux, was approved for late-stage colon cancer and after its approval many analysts believed that the drug, although shrinks tumors, it does not extend lives of patients. Further trials and analysis began to show that the drug, indeed, helps survival and is also effective in treating cancers other than colon cancer.

Recently, good news of efficacy was announced by the firm and its partner on the drug, BrystolMyers Squibb. In the relatively large multicenter studies, known as EXTREME, Erbitux was used in combination either with cisplatin plus 5-fluorouracil (5-FU) or carboplatin plus 5-FU on late-stage head and neck cancer, which exhausted all available treatments with no success. Compared with the results on patients treated with cisplatin plus 5-FU or carboplatin plus 5-FU alone, the results of Erbitux combination demonstrated much better efficacy. This news is extremely interesting as it could move Erbitux from a treatment for late-stage cancers to early cancers, which is good news for patients, the company and its shareholders. We will hear the details of these results in June at the American Society of Clinical Oncology.