Celsion Corp. said yesterday that patient enrollment in a pivotal human test of its treatment for enlarged prostates has picked up after a slow start and could be fully enrolled by the end of October.
The Columbia-based company said in a letter to shareholders that it still anticipates that it could get government approval for the prostate treatment as soon as spring or early summer. But Jim McCamant, editor-at-large of the Medical Technology Stock Letter, based in Berkeley, Calif., and an analyst with Boston-based Moors & Cabot, said the delays in patient enrollment likely mean that the company won't get approval for the treatment until the fourth quarter of 2002.
Meanwhile, Celsion is slowing human testing of its experimental breast-cancer treatment so it can focus on getting the prostate treatment to market, conserving its limited cash. Both treatments work by using a device designed to focus heat on problem areas while preserving surrounding healthy tissue.
Celsion is counting on the treatments to push it to profitability. It said yesterday that it had $4.6 million in cash at the end of June, giving it enough money to operate through year's end. Celsion said it intends to raise additional money in the fall.
"They've learned that getting patients enrolled and getting clinical trials going is not as easy" as it seems, McCamant said. But, he said, "I would expect the stock to begin responding" to good news.
The company's shares, which closed at a six-month high of $1.60 in late February on the American Stock Exchange, dived to 60 cents in late June and since have traded under $1. The decline came after Celsion was dropped from the reconfigured Russell 3000 index of the 3,000 largest U.S. companies, prompting certain mutual funds to sell shares, Chief Financial Officer Anthony Deasey said.
Pressure on the stock also came as holders of convertible preferred shares, which Celsion issued in January 2000, gained the right to convert them to common shares beginning Feb. 1, Deasey said. The conversion pushed the number of Celsion shares outstanding to 76.7 million, up from 64.5 million on Jan. 31.
In its letter to shareholders, the company emphasized recent steps to improve clinical trial enrollment, including the hiring of Daniel S. Reale as president of the division overseeing development of the benign prostatic hyperplasia (BPH) treatment. Reale formerly was managing director of international sales for the privately held biotechnology firm Intracel Corp. To handle the trials, Celsion signed up 10 urologists' offices that collectively treat tens of thousands of patients monthly.
Through the end of July, 18 patients had been treated in the BPH tests begun in October. The trial aims to treat 160 patients, 120 of whom will be treated with Celsion's experimental technology and 40 of whom will be treated with the drug Proscar for comparison.