16 Biotechnology Law Report 181 (Number 2, March-April 1997)

HemoCleanse Receives Approval for Studyof Hyperthermia in Lung Cancer

On February 10, the FDA approved a feasibility study of the Biologic-HTSystem for use during extracorporeal whole-body hyperthermia in patients withmetastatic non-small-cell carcinoma of the lung. The product, which monitorsand balances body chemistry during hyperthermia, is being developed byHemoCleanse, Inc. (West Lafayette, Ind.) and IDT, Inc., a subsidiary ofBiocontrol Technology, Inc. (Pittsburgh, Penn.). Other Biologic Systems arebeing used to support patients during acute hepatic coma and are being testedagainst HIV infection and other life-threatening diseases.

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{BLR 2352} Cell Robotics-

In Vitro Fertilization-

SBIR.

Cell Robotics files for IDE— In Vitro Fertilization Workstation Ready for Testing

ROCKVILLE, MD. 2/7/97 — Cell Robotics International, Inc.(Albuquerque, N.M.) today submitted an Investigational Device Exemption(IDE) application to the U.S. Food and Drug Administration covering thecompany's in vitro fertilization workstation. The device provides a standardizedmethod for examining embryos and offers laser-assisted preimplantationhatching, a technique that has improved the success rate of in vitro fertilizationin a European trial.

Cell Robotics plans to test the workstation at three sites in the UnitedStates and one each in Belgium and Israel.

The day it announced the filing of the IDE application, CRII reportedthat it had received a Small Business Innovative Research (SBIR) grant forapproximately $100,000 to help refine the workstation.

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{BLR 2353} AIDS-

Cidofovir-

Gilead Sciences-

Herpes Simplex.

GlLEAD FILES NDA FOR ClDOFOVIR GEL— Drug Aimed at Refractory Genital Herpes

ROCKVILLE, MD. 1/6/97 — Gilead Sciences, Inc. (Foster City, Cal.) hasfiled a New Drug Application with the FDA covering the use of cidofovir gel(Forvade) to clear genital herpes lesions in patients with AIDS. A double-blindclinical trial conducted to support the NDA enrolled patients whose disease didnot respond to the standard anti-herpes drug, acyclovir. In this trial, patients

16 Biotechnology Law Report 182 (Number 2, March-April 1997)

who received cidofovir had faster pain relief and lesion healing and stoppedshedding virus sooner than patients who were randomized to use the placebo.While the FDA reviews the NDA, Gilead is making the gel available through anexpanded access program.

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{BLR 2354} Information Management-

MDL Information Systems

MDL Signs material transfer agreement with FDA—Nonproprietary Parent Compounds to Be Added toMetabolite Database; ISIS to Be Transferred to Agency

SAN LEANDRO, CAL. 3/4/97—

MDL Information Systems, Inc. todayannounced the signing of a material transfer agreement with the Food and DrugAdministration. Under its terms, information on non-proprietary parentcompounds that has been submitted to the agency in applications for marketingapproval will be added to the Metabolite Database developed by MDL, asupplier of scientific information systems. The additions are expected to makethe Metabolite Database more helpful to pharmaceutical researchers. Theagreement also transfers MDL's integrated scientific information system (ISIS)family of products to the FDA for use by the Center for Drug Evaluation andResearch. The ISIS supports the registration, management, display, andanalysis of scientific information.

At present, the information that will be added to the Metabolite Databasecan be obtained through the Freedom of Information Act but is not easilyaccessed.

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{BLR 2355} Dr. David Kessler.

Press Clippings

"What's clear [as the biotechnology era enters its third decade] is that thebenefits ... are enormous while the hypothetical hazards have proven to belargely illusory. ... The pragmatic U.S. approach to regulating [it] — based onclose cooperation between industry and government — seems to me to beyielding hopeful harvests."

Rudy M. Baum, Managing EditorChemical & Engineering News

7 October 1996

Dr. David Kessler "is an extraordinary and intelligent public servant withpublic health foremost in his mind. [He] inherited an [FDA] that was averse tochange and with a culture that was not sensitive to the biological drug products