`
`08-06-2001 Comments (0)
`
`Celgene has demonstrated in a Phase I trial that its lead pipeline drug,the immunomodulator Revimid (CDC501), is safe and has some efficacy in
`the treatment of solid tumors. Revimid is a smallmolecule analog of thalidomide, which Celgene markets as Thalomid for an inflammatory
`complication of epilepsy (Marketletters passim) and which has shown promise in other indications, including some forms of cancer, and will be
`filed for multiple myeloma later this year.
`
`Revimid has been designed to improve upon the safety and and efficacy of Thalomid, which achieved sales of $62 million last year, and has
`already shown preliminary activity in multiple myeloma. Analysts have predicted that a safer version of the drug would have a high sales potential,
`given the number of indications in which thalidomide may be a therapeutic option. Thalomid is also being tested in renal cell, colorectal, bone and
`prostate cancer.
`
`The latest trial of Revimid involved 20 patients with solid tumors, including 13 with metastatic melanoma, two with pancreatic cancer, two with
`nonsmall cell lung cancer, two with breast cancer and one with metastatic renal cancer. The patients were treated with 5mg, 10mg, 25mg and
`50mg/day of Revimid. No laboratory abnormalities were noted in the study at any dose, and the only side effect was numbness in one hand of the
`renal cancer patient.
`
`A total of 13 patients had evidence of disease stabilization while on Revimid therapy and are continuing to receive the drug on a named-patient
`basis in an extension of the study. Eight patients in this group of responders had melanoma, and six of them had evidence of disease regression.
`Celgene has suggested that, if all goes well in future trials, Revimid could be on the market in 2003/2004.
`
`Files IND for breast cancer therapy
`
`Meantime, Celgene has also filed an Investigational New Drug application with the US Food and Drug Administration to start an openlabel, dose-
`escalation Phase I trial of SPC8490, a selective estrogen receptor modulatoralpha, to identify the maximum tolerated dose effective in the
`treatment of patients with metastatic breast cancer.
`
`Previous animal studies of SPC8490 showed that it was orally effective in treating breast cancer and demonstrated equal or superior efficacy to
`AstraZeneca's antiestrogen therapy Nolvadex (tamoxifen). In addition, the compound was active in tamoxifenresistant tumor cell lines and one
`hormonallyresponsive ovarian cancer cell line.
`
`Alpha
`
`AstraZeneca
`
`Nolvadex
`
`Prolastin
`
`tamoxifen
`
`Thalidomide
`
`Thalomid
`
`DR. REDDY’S LABS., INC. EX. 1013 PAGE 1
`
`