BioWorld International Correspondent

Algeta ASA is embarking on an IPO roadshow buoyed by an unexpected bonus. The company's Phase II clinical trial of its alpha-particle-emitting radionuclide Alpharadin, which had been powered to demonstrate a delay in disease progression in patients with hormone-refractory prostate cancer, also has yielded positive survival data.

The Oslo, Norway-based company reported the survival data at the American Society of Clinical Oncology (ASCO) Prostate Cancer Symposium in Orlando, Fla., last week. At 18 months follow-up, 15 patients in the drug treatment group (n=33) still were alive, whereas just six in the placebo group (n=31) were alive.

The median additional survival time was almost 25 weeks: 71 weeks in the treatment group compared to 46.4 weeks in the placebo group, for patients treated according to the study protocol. Patients receiving Alpharadin had a 53 percent lower risk of mortality (p=0.02) at any given time point versus those on placebo, the company said.

The primary endpoint of the study was to demonstrate a delay in disease progression as measured by reductions in prostate-specific antigen (PSA).

Those in the treatment group exhibited a 23.8 percent fall in PSA from baseline to four weeks after the last Alpharadin injection, whereas those in the placebo group exhibited a 44.9 percent increase. Previously disclosed data also indicated a positive impact on bone metastases, as measured by reductions in serum bone alkaline phosphatase.

The program is as yet unpartnered, and Algeta plans to take it into a pivotal trial itself. "In parallel to the Phase III trial, we will have discussions with interested parties to look at possible partnering arrangements. There's no immediate need to find a partner," CEO Thomas Ramdahl told BioWorld International.

The company raised €23 million (US$28.8 million) in a financing round last fall, which, unusual for Norwegian biotechnology, attracted several international venture capital funds. (See BioWorld International, Sept. 7, 2006.)

Algeta said at the beginning of this month it would seek a listing on the Oslo Stock Exchange. The IPO should be priced shortly. "That will be during March sometime," Ramdahl said.

Alpharadin, which contains the alpha emitter radium-223, currently is undergoing two other Phase II clinical trials, both involving about 100 patients. One is assessing its effects on disease progression, while the other is examining its contribution to relieving pain. Each will report early in 2008, Ramdahl said.

The current trial involved 11 centers in Norway, Sweden and the UK. The pivotal study will be more broadly based. "We are aiming to do a trial on both sides of the Atlantic," Ramdahl said.

Algeta is targeting the same indication as satraplatin, the orally available platinum compound for which GPC Biotech AG recently completed an NDA. GPC, of Martinsried, Germany, is due to report survival data from its Phase III clinical trial of satraplatin later this year.

That study already has demonstrated a 40 percent reduction in risk of disease progression. (See BioWorld International, Sept. 27, 2006.)

GPC presented those data, along with a more conservative analysis that put the reduction in the risk of disease progression at 33 percent, at the same ASCO symposium last week.

"Overall survival is still the gold standard for registration," Ramdahl said. Alpharadin will be positioned for the same patient population and could suit those patients unable to take chemotherapy.

"If you look at the side effects profile, they certainly have more side effects for their treatment than [we do]," he said.

The two compounds potentially could be used in combination as well, he added.