Good article on ONXX (4/9/02) from Forbes.com
Notes for comparison to Oncolytics:
- "Onyx-015 is in late-stage trials, but those trials have hardly moved forward since a partnership between Pfizer and Onyx was suspended in February."
- "At that time, Onyx sent a letter to shareholders saying that it was shifting focus away from Onyx-015 to another compound with Bayer."
- Adenovirus is "a particularly nasty common cold".
- Onyx-015 is a mutated adenovirus that seems to copy itself only in cells that lack a functioning copy of a gene called p53 that repairs damaged or mutated DNA.
- "But the drug has not been tested by the kind of clinical trials that determine definitively whether the drug actually works."
- "Manufacturing issues or no, Pfizer's decision not to continue is not exactly a ringing vote of confidence."
forbes.com
Biotechnology
Stock Pops, But Anti-Cancer Virus Is Unproven
Matthew Herper, 04.09.02, 3:11 PM ET
NEW YORK - Shares in a small cancer therapeutics company, Onyx Pharmaceuticals, yesterday skyrocketed 17% to nearly $6 in their heaviest trading this year. The so-called news: positive results on Onyx-015, an anti-cancer virus. But it turns out the results were not that new, new clinical trials of the virus are not ongoing, and the stock gave back 13% this morning.
Onyx's (nasdaq: ONXX - news - people ) pop is indicative of the problems often faced by investors in small biotechnology companies, where important news is often difficult to understand or incomplete, and well-publicized companies are already often overvalued. Its problems point to wider difficulties in using what are essentially common cold viruses to hunt and kill cancer cells or to act as messengers for genes that will cause cancer cells to commit suicide.
Onyx-015 is in late-stage trials, but those trials have hardly moved forward since a partnership between Pfizer (nyse: PFE - news - people ) and Onyx was suspended in February. At that time, Onyx sent a letter to shareholders saying that it was shifting focus away from Onyx-015 to another compound with Bayer (nyse: BAY - news - people ).
However, says Chief Executive Hollings Renton, a researcher associated with Onyx, will present some new data on a previously published study today at a meeting at the American Association of Cancer Researchers. The data, to be presented by Stanford University's Tony Reed, uses chemical markers and other data to measure how much Onyx-015 is helping them.
Onyx is trying to fight cancer with an adenovirus, a particularly nasty common cold. Onyx-015 is a mutated adenovirus that seems to copy itself only in cells that lack a functioning copy of a gene called p53 that repairs damaged or mutated DNA. If the DNA is too smashed up to be repaired, p53 instructs the cell to self-destruct. Since cancer occurs when DNA becomes so badly battered that it stops regulating cell growth and behavior, it is not surprising p53 has stopped working in more than half of human tumors.
Because Onyx-015 can copy itself only in cells that lack p53, it should kill tumor cells, but not healthy ones. But the drug has not been tested by the kind of clinical trials that determine definitively whether the drug actually works. Manufacturing issues or no, Pfizer's decision not to continue is not exactly a ringing vote of confidence.
Although Onyx is farthest in trying to mutate cold viruses so that they selectively hunt and kill cancer cells, other firms are also using adenovirus to attack p53. Schering-Plough (nyse: SGP - news - people ) and Introgen (nasdaq: INGN - news - people ) are also both using the virus as a cancer fighter, according to Stephens analyst Jason Zhang, who puts together a comprehensive annual report on biotech cancer research.
The Schering-Plough and Introgen approaches are very different from Onyx's approach. Instead of using adenovirus to kill cancer cells, they are using it as a messenger. In a gene therapy approach, the adenovirus is used to get working copies of the p53 gene into cells. In theory, at least, this should cause the cancer cells, which have badly damaged DNA, to self-destruct. But firms' viruses are in late-stage (Phase III) clinical trials.
It has been very difficult to produce drugs that work by repairing p53 function, says Zhang. The only non-viral p53 drug Zhang lists in Phase III trials is Genta's (nasdaq: GNTA - news - people ) Genasense.
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