Washington Editor

Celsion Corp. strengthened its gene therapy portfolio through the acquisition of exclusive worldwide commercialization rights to a package of technologies developed at the National Institutes of Health, company officials said.

In its quarterly conference call with investors, analysts and reporters Tuesday, Augustine Cheung, Celsion's CEO and chief scientific officer, said the licensed technology gives Celsion the right to develop heat-sensitive gene therapy products activated by microwave heat energy.

The technology is covered by a pending patent that deals with the steps involved in creating temperature-sensitive therapeutic genes, and with the use of heat energy to activate and control gene therapy, Cheung said.

"The license gives us much greater freedom to develop and commercialize products in [this] area," Cheung said. "Celsion's goal is to develop temperature genes for cancer that perform only when activated by the energy focused at the tumor."

Regarding the financial contract between the NIH, of Bethesda, Md., and Celsion, of Columbia, Md., Daniel Reale, Celsion's executive vice president and head of the oncology division, told BioWorld Today Celsion would owe the government a royalty if it developed a product from the technology. Other terms of the contract are confidential, he said.

Incorporated in 1982, Celsion, is a biomedical company developing medical treatment systems mainly for breast cancer and benign prostate hyperplasia (BPH, also called enlarged prostate), using its heat technology.

Celsion owns exclusive worldwide rights to a heat-activated, antisense genetic biological modifier developed at Memorial Sloan-Kettering Cancer Center and has the option to acquire from Duke University a technology that uses heat to induce genetic anti-angiogenesis and to regulate immunogene therapy.

Cheung said the company's microwave heating technology, together with the technology covered under the NIH patents, forms a platform from which many controllable tumor-targeting genetic products could be developed.

The company believes it will receive FDA approval late this year or in early 2004 for its BPH product, a minimally invasive microwave urethroplasty treatment system designed to deliver the efficacy of surgical treatments without the risks. Specifically, the system works by using moderate-temperature microwave heat combined with pressure exerted by a balloon catheter to produce a natural stent, unblocking the urethra. The 45-minute treatment given in the doctor's office does not require sedation, and in up to 80 percent of cases, post-operative catheterization is not required.

Boston Scientific Corp., of Natick, Mass., will distribute the product internationally. The two entered the agreement in January, at which time Boston Scientific made a $5 million equity investment in Celsion and agreed to pay another $10 million once the BPH product is approved and launched. Boston Scientific, which owns about 7 percent of Celsion, also has an option to purchase the BPH asset for $60 million over five years, Reale told BioWorld Today.

In the conference call, Celsion said the company has $11 million in cash, 140 million outstanding shares and a burn rate of about $700,000 per month.

Celsion expects its burn rate to increase to $900,000 to $1 million over the next several months as it continues trials for its microwave products. For example, it is currently accruing patients for a randomized, pivotal trial to assess the safety and efficacy of focused microwave thermotherapy treatment plus pre-operative chemotherapy vs. pre-operative chemotherapy alone for cytroreduction of advanced breast cancer in intact breasts.

Celsion's stock (AMEX:CLN) closed Tuesday at $1.17, up 3 cents.

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