Dr. Agnes Schulte is awarded for her publication entitled "Two immunotoxicity ring studies according to OECD TG 407 - Comparison of data on cyclosporin A and Hexachlorobenzene" (1). In this publication, Dr. Schulte has brought together the results of the two international collaborative studies on immunotoxicity initiated by the BGVV (former BGA) together with a large number of industry research laboratories from various countries in Europe. Her paper shows impressively the value of a cooperation between regulatory authorities and industry on the validation and standardization of investigations in the field of toxicologic pathology. By this, it was possible to determine the sensitivity and predictability of different methods for the detection of immunomodulation, and it turned out that the most reliable and sensitive data to distinguish immunosuppression and -stimulation were achieved by histomorphologic examination. However, the particular value of other immune parameters as functional tests and cell counts was likewise demonstrated in her publication.

The rationale of the two studies which were coordinated and compiled by Agnes Schulte was to detect immunomodulatory compounds based on the protocol of the OECD test guideline 407. In consequence of the encouraging results of the study on the immunosuppressant Cyclosporine A presented by her and her coworkers in 1995 and 1996, a second study with the immunostimulatory compound Hexachlorobenzene was performed on the same basis. The results of this second study were published in 2000.

During this collaborative work, Agnes Schulte gave impulses for an intense scientific discussion between the participating laboratories. Due to her efforts additional parameters could be tested that were not part of the former OECD TG 407 from 1981 and she confirmed the appropriateness of additional test parameters included in the new OECD TG 407 issued 1995.

Thus, the ESTP Award 2004 is given to Dr. Agnes Schulte in recognition of her intensive research and validation activities in the field of immunotoxicolology. Her publication "Two immunotoxicity ring studies according to OECD TG 407 - Comparison of data on cyclosporin A and Hexachlorobenzene" is the comprehension of this work.

References:

1. Schulte A, Althoff J, Ewe S, Richter-Reichhelm HB, and the BGVV group investigators (2002) Two immunotoxicity ring studies according to OECD TG 407 - Comparison of data on cyclosporin A and hexachlorobenzene. Regul Toxicol Pharmacol 36: 12-21
   
   
2. Richter-Reichhelm HB, Dasenbrock C, Descotes G, Emmendörffer AC, Ernst HU, Harleman JH, Hildebrand B, Küttler K, Rühl-Fehlert CI, Schilling K, Schulte A, Vohr HW (1995) Validation of a modified 28-day rat study to evidence effects of test compounds on the immune system. Regul Toxicol Pharmacol 22: 54-66
   
   
3. Richter-Reichhelm HB, Schulte AE (1996) Evaluation of the appropriateness of the extended subacute (28 day-) toxicity test to detect adverse effects on the immune system. BgVV-Heft 04/1996, Berlin
   
   
4. Schulte A, et al. (2000) Screening for immunotoxic effects. Ring study with hexachlorobenzene based on the enhanced OECD test guideline 407. BgVV-Heft 07/2000, Volume I and II; Berlin

Lindau, October 1, 2004

* sponsored by Novartis Pharma AG