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Published on: September 17, 2014
CCI-779 Wyeth
1Hamilton Regional Cancer Center, Ontario, Canada. laurie.elit@hrcc.on.ca
Abstract:
Wyeth Research (formerly Wyeth-Ayerst Research) is developing the sirolimus (rapamycin) analog CCI-779 as a potential treatment for various cancers [320924]. By November 2001, phase III trials had been initiated [428972], [429576]. In October 2001, Raymond James predicted filing in 2003, with a potential launch in 2005 [426718]. In March 2002, CCI-779, was designated for fast-track development by the FDA for the treatment of renal cell carcinoma after failure of initial therapy [442535]; at this time phase III trials for renal cell carcinoma and phase II trials for various solid tumors were ongoing [444030]. In March 2002, Wyeth revealed that filing was anticipated for 2004/2005 [443491]. In June and August 2001, Lehman Brothers predicted sales of US $40 million ($20 million in the US) in 2003, rising to US $75 million ($38 million in the US) in 2004 [418901], [420809]. In October 2001, analysts at Raymond James expected potential sales of the product at US $250 million [426718]. In May 2002, a patent (WO-00240000) was published claiming CCI-779 to be useful for the treatment of cancers of various origins, including renal, breast, cervical, uterine, head and neck, lung, prostate, pancreatic, ovarian, colon, lymphoma and melanoma.
Insights
Wyeth Research is developing CCI-779, a sirolimus analog, for various cancers. Phase III trials are underway, with FDA fast-track designation for renal cell carcinoma, and potential filing anticipated in 2004/2005.
Area of Science:
- Oncology
- Pharmacology
Background:
- Wyeth Research is developing CCI-779, a novel analog of sirolimus (rapamycin).
- CCI-779 is being investigated as a potential therapeutic agent for a range of malignancies.
Purpose of the Study:
- To evaluate the efficacy and safety of CCI-779 in patients with various cancers.
- To secure regulatory approval for CCI-779 as a cancer treatment.
Main Methods:
- Clinical trials, including Phase II and Phase III studies, are being conducted.
- The U.S. Food and Drug Administration (FDA) has granted fast-track designation for renal cell carcinoma treatment.
Main Results:
- Phase III trials for renal cell carcinoma and Phase II trials for solid tumors are ongoing.
- A patent has been published claiming CCI-779's utility in treating diverse cancers, including renal, breast, lung, and melanoma.
Conclusions:
- CCI-779 shows promise as a treatment for various cancers.
- Regulatory filing is anticipated in the 2004/2005 timeframe, with potential market launch in 2005.

