By Brady Huggett
One way to keep a low profile is to keep silent, and Corgentech Inc. has been doing just that.
But the privately held company now has its shoulder against the Phase III door with an unpartnered product ¿ which is just the way it wants things.
Corgentech, of Palo Alto, Calif., received approval to initiate Phase III trials with its lead product, the E2F Decoy, for the treatment of peripheral bypass graft surgery. The trial is scheduled to begin next month, and that step would bring Corgentech closer to putting what it believes is a potential blockbuster product on the market.
¿Nobody has really heard of us and we are on the verge of Phase III with very nice data,¿ said John McLaughlin, Corgentech¿s CEO and president. ¿We¿ve been very quiet, but we are starting to get some visibility now.¿
The first of 1,400 Phase III patients is expected to be enrolled by mid-September, McLaughlin said, and patients will be examined after one, three, six and nine months before the trial ends at one year. The E2F Decoy, which has been granted fast-track status, works to prevent occlusion in grafted veins ¿ in the case of this trial, leg veins.
¿It¿s a short strip of DNA that binds to a consensus region of a transcription factor,¿ McLaughlin said. ¿What we are doing is shutting down the proliferation of smooth muscle cells by binding E2F and preventing the activation of its target genes which cause those cells to proliferate.¿
In the course of surgery, the vein is removed from the patient¿s leg, then soaked in the compound and put under extremely low, non-distending pressure in a device that is part of the E2F Decoy treatment. Once that is complete, the vein is ready for grafting.
The primary endpoint in the trial will be a comparison between the treatment and placebo groups regarding the need for surgical revision of the graft, or amputation. The secondary endpoint will compare incidences of graft occlusion.
McLaughlin said that when a leg vein is occluded, whether it be through cardiovascular disease, diabetes or some other cause, and a bypass vein is implanted, 30 percent to 50 percent of grafted veins fail over a ten-year cycle. In a Corgentech Phase I/II trial with its E2F Decoy, that failure rate was reduced by 58 percent over a 12-month period.
The Phase III trial will look for a 30 percent difference between the placebo group and the E2F Decoy-treated group.
A second Phase III trial will examine the product in coronary bypass graft failure; it is scheduled to start in the fourth quarter. When data from both trials are gathered and analyzed, Corgentech will be ready to file. McLaughlin said that as the trials progress, Corgentech would get a clearer picture of a filing timeline.
Corgentech is ¿in the midst¿ of a Series C private financing, McLaughlin said. It raised $13 million in its Series B, closed in May, and has raised $15.5 million to date. In a slumping market and with Corgentech having plenty on its plate, McLaughlin said the company would not worry about an initial public offering this year. (See BioWorld Today, May 4, 2001.)
With a late-stage product and still privately held, Corgentech has not partnered the E2F Decoy. But that doesn¿t mean it won¿t, but it will do so on its terms.
¿We¿ve been approached by several partners for worldwide deals ¿ we are not interested in worldwide deals,¿ McLaughlin said. ¿We will look at deals in Asia and the [European Union], but in the United States we would like to hold onto the product ourselves and market it ourselves.¿
¿We see an area where we can build a franchise,¿ McLaughlin added. ¿There aren¿t a lot of companies working on this.¿ Those that are, McLaughlin said, are using different methods, such as conduits and pumps, which leaves an area Corgentech would love to dominate. McLaughlin estimated that the E2F Decoy could generate as much as $650 million in worldwide sales merely a couple of years following launch. Those are big numbers, potential blockbuster numbers.
¿There aren¿t many of those floating around,¿ he said.
The key to biotechnology gigantism is not only a big-market product, but also a well-developed pipeline, something Corgentech is aware of.
¿We also have four research-stage programs and one should get into the clinic next year,¿ McLaughlin said. ¿This is a technology with the ability to very rapidly generate clinical candidates. We aren¿t talking about years, we are talking in terms of months.¿