Dr. Zvi Fuks, a renowned radiation oncologist, is one of the principal developers of 3-D conformal radiation therapy, a system for delivering radiation that permits precise shaping and targeting of radiotherapy beams. He has worked for many years at MSKCC (memorial Sloan-Kettering Cancer Center).

Last month Dr. Fuks and a friend agreed to pay a total of $2.77 million to settle a lawsuit accusing them of insider trading in shares of a pharmaceutical company. The drug involved, ImClone’s Erbitux, was tested in clinical trials at MSKCC. A clinical trial of Erbitux for prostate cancer ran at MSKCC starting in 1996.

Dr. Fuks sold his stock on a tip from a company insider, Samuel D. Waksal, the former chief executive of ImClone Systems. At the time, Erbitux (known as C225 and as cetuximab) was running into roadblocks at the FDA over approval.

Mr. Waksal tipped them off that regulators were probably going to reject the company’s cancer drug Erbitux, the Securities and Exchange Commission said yesterday. The settlement covers the losses they avoided when the shares subsequently fell 16 percent.

The story was blown wide open by The Cancer Letter, a small, highly influential journal published by Kirsten Boyd Goldberg and edited by Paul Goldberg.

In 2004, the FDA approved Erbitux (generic name cetuximab) to treat patients with advanced colorectal cancer that has spread to other parts of the body. This made Eribitux the first monoclonal antibody approved to treat this type of cancer. It is “indicated as a combination treatment to be given intravenously with irinotecan, another drug approved to fight colorectal cancer, or alone if patients cannot tolerate irinotecan.”

Erbitux targets the epidemeral growth factor. If the patient has a good, positive response, the drug usually causes a skin rash which may affect the face. But does not suppress bone marrow nor suppress hormones.

For a patient’s view of the impact on patients see Imclone Debacle, What Does it Mean by Bill Aishman

S.E.C. Settles ImClone Insider Trading Suit – New York Times reports that “Mr. Waksal is serving a seven-year sentence. Martha Stewart, another friend of Mr. Waksal, served a five-month prison term for lying to prosecutors about her own sales of ImClone stock…. Dr. Fuks will pay $2.66 million to the S.E.C. Ms. Ben-Yehuda agreed to pay about $110,000. Neither admitted or denied wrongdoing as part of the settlement. Prosecutors dropped a criminal complaint against Dr. Fuks and Ms. Ben-Yehuda in August. The settlement with the S.E.C. is subject to approval by a federal judge in New York.”