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Letter to the Editor

Nimotuzumab: Evidence of Clinical Benefit Without Rash

YM BioSciences Inc., Mississauga, Ontario, Canada

David G.P. Allan, Chairman, Chief Executive Officer, YM BioSciences Inc., 5045 Orbitor Drive, Building 11, Suite 400, Mississauga, Ontario, Canada L4W 4Y4. Telephone: 905-629-9761; Fax: 905-629-4959: e-mail: dallan{at}ymbiosciences.com

Received May 29, 2005; accepted for publication September 19, 2005.

It is regrettable that the otherwise compelling paper by Perez-Soler et al. [1] omitted to mention that the epidermal growth factor receptor (EGFR)–targeting monoclonal antibody nimotuzumab (YM BioSciences Inc., Mississauga, Canada, http://www.ymbiosciences.com) has demonstrated evidence of no rash in numerous clinical trials, notwithstanding its clinical benefit being equivalent or superior to those of other epidermal growth factor monoclonal antibodies.

Evidence from a trial in head and neck cancer was published in 2004 in the Journal of Clinical Oncology (JCO) [2] in a presentation on a pediatric glioma trial to the European High-Grade Glioma Meeting on February 26, 2005, and has been referenced in numerous press releases in respect to clinical trials conducted by YM BioSciences Inc. or other companies associated with the development of this monoclonal antibody.

Clinical benefit in the absence of rash was noted by the Chinese regulatory authorities in a 130-patient randomized pivotal phase II trial completed in 2004, in which the data were sufficiently compelling to permit approval for nimotuzumab in that market [3].

The absence of rash was further confirmed in a poster on a 24-patient phase II trial in adult glioma presented by YM BioSciences’ licensor, the Center of Molecular Immunology, at the 2005 American Society of Clinical Oncology Annual Meeting [4]. While we appreciate that this latter was after the submission of the referenced paper, there is clearly sufficient published information supportive of nimotuzumab’s clinical efficacy in the absence of any "acneiform" rash.

We use the inverted commas in deference to the referenced paper, which notes that the word "acneiform" should be avoided until there is a specific dermatological definition. Notwithstanding the paper, we note that ImClone’s monograph that describes an 88% incidence of rash specifically uses the word "acneiform" [5].

The JCO paper described addresses the probable reasons for the absence of rash from treatment with nimotuzumab, and we would greatly appreciate the error of the implication in the referenced The Oncologist paper, namely, that all HER-1/EGFR drugs cause rash, being reversed by your excellent journal, referencing both the JCO paper and the clinical evidence. The absence of rash is a matter of fact whereas the referenced paper is a matter of conjecture, and we would appreciate an appropriate reference in your journal to the facts.

We would further point out that, not only does nimotuzumab have the specific benefit of an absence of rash (which may make it the only drug inhibiting this pathway that may be useful in a chronic setting), but there is also evidence of no diarrhea or anaphylaxsis, one or both of which conditions are evident in all other products being developed in North America.

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Pérez-Soler Román, Delord Jean Pierre, Halpern Allan et al. HER1/EGFR inhibitor-associated rash: future directions for management and investigation outcomes from the HER1/EGFR inhibitor rash management forum. The Oncologist 2005;10,:345-356.[Abstract/Free Full Text]

	DISCLOSURE OF POTENTIAL CONFLICTS OF INTEREST

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The author is chairman and chief executive officer of YM BioSciences, which holds a license for the development of Nimotuzumab in certain territories.

	REFERENCES

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1. Pérez-Soler R, Delord JP, Halpern A et al. HER1/EGFR inhibitor-associated rash: future directions for management and investigation outcomes from the HER1/EGFR inhibitor rash management forum. The Oncologist 2005;10:345–356.
2. Crombet T, Osorio M, Cruz T et al. Use of the humanized anti-epidermal growth factor receptor monoclonal antibody h-R3 in combination with radiotherapy in the treatment of locally advanced head and neck cancer patients. J Clin Oncol 2004;22:1646–1654.[Abstract/Free Full Text]
3. YM BioSciences Reports Positive EGF-R Antibody Pivotal Phase II Results. Available at http://www.ymbiosciences.com/presspop.cfm?newsID=3450. Accessed May 17, 2005.
4. Crombet T. Use of the humanized anti-EGFR antibody nimotuzumab and radiation for the treatment of patients with high-grade astrocytic tumors. Presented at the Annual Meeting of the American Society of Clinical Oncology, Orlando, Florida, May 13–17, 2005.
5. Erbitux® [package insert] Cetuximab prescribing information. New York, NY: ImClone Systems Inc., 2004. http://www.erbitux.com.

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