Cell Therapeutics' Cancer Drug Fails Trial

Cell Therapeutics (CTIC) often talks about the promise of its pipeline, though it has very little cash to do anything about it. The money raise it did today allows the company to postpone a July 1 bankruptcy to the end of the year. The company doesn't have enough money to complete a new pixantrone pivotal trial required by the FDA for approval. Unless its shareholders vote management 400 million more common shares to play with, Cell Therapeutics can't even raise the money.

Cell Therapeutics is notable because it has spent more than $1.4 billion in shareholder money without ever taking a drug through the approval process. It bought an approved drug and failed miserably at trying to market it. Nevertheless, Cell Therapeutics management manages to keep shareholders from revolting by promising that bigger and better things are just around the corner. One of those “better things” was supposed to be brostallicin, a new cancer drug the company is developing.

However, an abstract of next month's American Society of Clinical Oncology (ASCO) meeting reports that brostallicin badly failed an important randomized Phase II trial.

This was a randomized Phase II trial comparing brostallicin to the chemotherapy drug doxorubicin. They theory behind brostallicin was that it was less toxic and either equally or more effective than older drugs.

In this trial, investigators tried this theory out on patients with metastatic soft-tissue sarcoma (cancer). Patients in this trial were over 60 years of age and not fit enough to receive traditional combination chemotherapy. Patients received either brostallicin or doxorubicin. The primary endpoint of the study was tumor stabilization at 26 weeks. To be considered a success, about half the patients in the brostallicin arm needed to have stable disease or better. A total of 118 patients were enrolled.

Brostallicin failed the primary endpoint. Only 5 of 77 (6.5%) patients had stable disease or better where 37 were needed to call the trial a "success." On the other side, 10 of 36 (27.8%) of the doxorubicin patients had a successful outcome.

The secondary endpoints were no better.

On progression-free survival at one year, brostallicin mustered just 6.5% versus doxorubicin at 15.6%. Overall tumor response rate, the combination of complete and partial responses, had doxorubicin at 21.1% compared to only 3.9% for brostallicin.

One doesn't often see such a drug fail a trial as badly as brostallicin failed this trial. Cell Therapeutics touted the start of a brostallicin trial in triple-negative breast cancer in a press release in late April. Given these results, the smart money wouldn't bet on a successful outcome of this new trial.

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