Six NIH technologies that have been developed into commercial products are featured in Federal Technology Transfer 2006, a new booklet from the Federal Laboratory Consortium (FLC).

The booklet is a compilation of some of the most promising projects from FLC's member laboratories and agencies during the past year. It highlights the benefits of technology projects that were developed through American investment in federal research and development.

Kepivance®, sold by Amgen, improves the quality of life of approximately 11,000 cancer patients per year. It reduces the severity and duration of mucositis (ulceration in the lining of the mouth) in patients who are undergoing radiation and/or chemotherapy prior to bone marrow transplantation. Musositis makes everyday activities such as eating, drinking, and swallowing painful or impossible, and prior to Kepivance®, there was no effective treatment for this condition. The active component of Kepivance®, keratinocyte growth factor (KGF), was discovered by scientists at the National Cancer Institute (NCI), and was developed into a clinically effective drug by NCI and its corporate partner, Amgen.

Thyrogen® allows thyroid cancer patients to avoid hormone withdrawal symptoms during annual cancer recurrence checks. More than 25,000 cases of thyroid cancer are diagnosed each year, and patients require annual follow-up testing to assure that they remain cancer-free. Thyroid hormone withdrawal leads to symptoms including fatigue, weight gain, and impaired memory and concentration. An alternative to stopping hormone replacement was found when scientists at the National Institute of Diabetes, Digestive and Kidney Disease (NIDDK), studying recombinant human thyroid stimulating hormone (rhTSH), partnered with Integrated Genetics (now part of Genzyme Corporation). Under a Cooperative Research and Development Agreement (CRADA), rhTSH was developed, approved by the FDA, and marketed as Thyrogen®.

Taxus Express2™ is a device that has revolutionized the treatment of many victims of cardiovascular disease, which causes 40% of all deaths in the US. After a heart attack, patients may undergo angioplasty, a less-invasive alternative to bypass surgery, and a device called a stent is placed into the artery to keep it open. However, restenosis (or reblocking) of the artery is a common side effect. Scientists at the National Institute of Aging (NIA) tested in animal models a stent coated with a drug-releasing polymer designed to prevent restenosis. After the original discovery, the technology was licensed by Angiotech, who collaborated with Boston Scientific to refine the original prototype and test it in humans. Since coming to market, this revolutionary drug-device combination has dramatically reduced restenosis rates to 3 to 6 percent in angioplasty patients.

Velcade™ provides hope to patients with resistant myeloma, and is the first treatment in over a decade to be approved by the FDA for this indication. Myeloma accounts for 2 percent of cancer deaths each year, and myeloma often recurs after treatment with currently available drugs. Velcade™ is the first in a new class of drugs called proteasome inhibitors, and its development and approval was one of the most rapid for a cancer treatment. The active ingredient was discovered by Myogenetics (later renamed ProScript), and preclinical studies were conducted with institutions that included the National Cancer Institute (NCI). Under a Cooperative Research and Development Agreement (CRADA), the formulation of the compound was improved, and Millennium Pharmaceuticals, which had acquired ProScript, licensed it for further development. Velcade™ is being clinically tested against a wide variety of other cancers.

Synagis®, a monoclonal antibody therapy from MedImmune, helps protect chronically ill or premature infants from a life-threatening respiratory infection. Respiratory Syncitial Virus (RSV) often manifests as a cold in older children or adults; however, for very young patients with compromised lungs, this infection may require a trip to the hospital, with limited treatment options. Each year, 125,000 infants in the US are hospitalized with severe RSV infections. Synagis® is a monoclonal antibody therapy that prevents RSV infection, and is the first monoclonal antibody successfully developed for an infectious disease. Monoclonal antibodies against RSV were developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), and were subsequently licensed to MedImmune under a Biological Material License. MedImmune continued developing this therapy and guided it to FDA approval. Synagis® treatment has resulted in a 55% reduction in the RSV hospitalization rate in high-risk infants.

Laser capture microdissection (LCM) technology allows the reliable retrieval of specific cells from microscopic tissue samples. This is a vital component of cancer research, where a pure cell population for analysis enables researchers to trace molecular events leading to pathogenesis. Scientists from the National Cancer Institute (NCI), who formed the idea of tissue sample microdissection, teamed up with scientists from the National Institute of Child and Human Development (NICHD) to develop a prototype LCM unit. Under a Cooperative Research and Development Agreement (CRADA), Arcturus Engineering, Inc. collaborated with NIH to further develop and commercialize this technology. LCM is now used widely in research on breast, prostate, and pancreatic cancers, with over 700 articles published that utilize this technology.

An electronic version of the Federal Technology Transfer 2006 booklet (PDF) can be viewed at http://www.federallabs.org/pdf/Federal_T2_2006.pdf.