ImClone: Non-Justifiable Scientific Downgrades Refuted

Aug. 6.08 | About: ImClone Systems (IMCL)

The recent findings of clinical trials on the safety and efficacy of ImClone Systems' (IMCL) Erbitux in regard to advanced colo-rectal cancer refute the frivolous claim/downgrade by Friedman, Billings Ramsey & Co. analyst Jim Reddoch.

The above mentioned analysts, who have absolutely no medical training in evaluating clinical trials, cited the following concerns:

1. Though the response rate for the Eibitux in combination with chemotherapy hit 52 percent versus 38 percent for patients treated with chemotherapy alone, survival rates did not significantly differ between the two groups.

Contrary to what the analysts state above, on June 3, 2008, according to results shown at the American Society of Clinical Oncology conference in Chicago, Erbitux and chemotherapy given to colorectal cancer patients not only produced a dramatic increase in the treatment response rate, but increased the survival rate by 26% compared to subjects who received chemotherapy alone. Moreover, statistical variance analysis on the methodology of the trial's design did not suggest any shortcoming factors, such as placebo affects or lack of variable controls.

Furthermore, In addressing the analysts' concern regarding the insignificant survival rates between the two groups in the study, it's important to note that the study involved 238 people, though it was originally meant to enroll 2,200. Results were obtained from a cancer and leukemia Group B randomized clinical trial (CALGB-80203) of ERBITUX in the treatment of patients with previously untreated metastatic colorectal cancer. An expert in the field of clinical trials would understand that he number of subjects tested was considered a small population and was well below the average of 560-- which the majority of phase 3 clinical trials enroll.

Because enrollment was closed at 238 patients, the results represented only 11% of the intended power to account for an evolving standard of care. Simply stated, the survival and progression free survival endpoints were not sufficiently powered to reach statistical significance. That said, analysts from both firms were wrong in advising clients that results from this study could foreshadow other similar studies on Erbitux in combination with other treatments.

This assumption is not only un-scientific, but also without constructive criticism. Allen Venook, M.D., Professor, Clinical Medicine, University of California, San Francisco, was the principle investigator in the study.

2. The data calls into question Erbitux's long-term value and could diminish the likelihood of an acquisition with a significant premium.

The long term value of Erbitux is evident by its safe and efficacious data, which proved to prolong the lives of the terminally ill. As to the likelihood of an acquisition, if a bid of 60 dollars/share (rise from a 6-month average of 41) is not significant, I don't what is.

Moreover, in the most recent study, Markus Borner, M.D., of the Institute of Medical Oncology, Inselspital, Berne, Switzerland, presented preliminary results from a Swiss Group for Clinical Cancer Research randomized Phase II study of capecitabine and oxaliplatin with or without ERBITUX as first line treatment of patients with metastatic colorectal cancer.

Objective response rate was the primary endpoint of the study. A total of 74 patients were recruited for the study and evaluable for preliminary response after follow up for at least nine weeks. Following a median of four treatment cycles, response rates were 43% (21/44) in the chemotherapy alone arm and 61% (23/44) in the combination ERBITUX and chemotherapy arm. The rate of disease control was 76% and 87% in the chemotherapy and chemotherapy plus ERBITUX arms, respectively.

Disclosure: none