BioWorld International Correspondent

BioXell SpA raised €23 million in a third financing round to move its lead drug candidate, BXL-628, into Phase II trials in four indications, all of which will be under way by next year.

BB Biotech, of Zug, Switzerland, led the transaction. Also participating were NIF Ventures, of Tokyo, and QVentures, of Bad Homburg, Germany, as new investors. Existing shareholders MPM Capital, Index Ventures, AlpInvest Partners, Life Science Partners and Investimenti Piccole Imprese participated, as well.

"We're funded through 2007," said BioXell Chief Business Officer Alex Martin. Raising the cash was a relatively straightforward process. "I think they liked the fact that we had a positive Phase II product."

The product in question, a vitamin D3 analogue with multiple biological effects, has completed a Phase II trial in 120 patients with benign prostatic hyperplasia (BPH). Those receiving the drug exhibited a 7.2 percent reduction in prostate volume as compared to those taking placebo.

Milan, Italy-based BioXell initially planned to move the product into a Phase III study but, on advice from its regulatory advisory board, instead opted to pursue a dose-finding Phase IIb study, which will recruit 600 patients. Martin said the trial will have four dosing arms: 75 micrograms, 150 micrograms, combination therapy involving BXL-628 plus an alpha-adrenergic receptor antagonist, and placebo.

The company gained rights to BXL-628 in BPH, secondary hyperparathyroidism, transplant rejection and Type I diabetes when it was spun out of Basel, Switzerland-based F. Hoffmann-La Roche Ltd. in January 2002. In June, it purchased further rights to the compound, covering all non-dermatological and non-topical indications, which paved the way for the additional three trials, all of which are in the urology field. BioXell is targeting overactive bladder, interstitial cystitis and chronic prostatitis. It might conduct trials in the latter two indications in the U.S.

"The diseases are better understood and better characterized over there," Martin said.

Roche retains a 15 percent stake in the company, although it has waived options that gave it first right of refusal on BXL-628.

"We are holding partnering discussions now. My sense is if we get a transformational deal, we'll do it now," Martin said. Otherwise, the company will generate more clinical data before entering an agreement. "It's our lead asset. We want to make sure we do it right," he said.