-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WK/M4ScUaUVhr7Ugtkh9vWdHIPPapJES46A4qwkjTC2himaV8jyCwYSNz87rVdIh 0xu2YnHere6ec+AK12dF0w== 0001275287-05-002260.txt : 20050620 0001275287-05-002260.hdr.sgml : 20050617 20050620060524 ACCESSION NUMBER: 0001275287-05-002260 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050620 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050620 DATE AS OF CHANGE: 20050620 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TRANSGENOMIC INC CENTRAL INDEX KEY: 0001043961 STANDARD INDUSTRIAL CLASSIFICATION: LABORATORY ANALYTICAL INSTRUMENTS [3826] IRS NUMBER: 911789357 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-30975 FILM NUMBER: 05904516 BUSINESS ADDRESS: STREET 1: 12325 EMMET ST CITY: OMAHA STATE: NE ZIP: 68164 BUSINESS PHONE: 4027385480 MAIL ADDRESS: STREET 1: 12325 EMMET STREET CITY: OMAHA STATE: NE ZIP: 68164 8-K 1 ti2940.txt ================================================================================ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): JUNE 20, 2005 TRANSGENOMIC, INC. (Exact name of registrant as specified in its charter) Delaware 000-30975 (State of Formation) (Commission File Number) 911789357 (IRS Employer Identification Number) 12325 Emmet Street Omaha, NE 68164 (Address of principal executive offices) (Zip Code) (402) 452-5400 (Registrants' telephone number, including area code) Not applicable (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e(c)) ================================================================================ ITEM 8.01 OTHER EVENTS. On June 20, 2005, the Company issued a press release announcing the publication of a study demonstrating the ability of its WAVE System to enable detection of mutations in the BCR-ABL gene that are associated with development of resistance to imatinib therapy in Chronic Myeloid Leukemia (CML) patients. A copy of the press release is filed herewith as Item 9.01 and is incorporated herein by reference. ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS. Exhibits (99) Press Release, dated June 20, 2005, announcing that the Company is publishing a study demonstrating the ability of its WAVE System to enable detection of mutations in the BCR-ABL gene that are associated with development of resistance to imatinib therapy in Chronic Myeloid Leukemia (CML) patients. 2 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. TRANSGENOMIC, INC. By /s/ Michael Summers ----------------------- Michael Summers Chief Financial Officer June 20, 2005 3 EX-99 2 ti2940ex99.txt Exhibit 99 TRANSGENOMIC'S WAVE(R) SYSTEM USED FOR EARLY DETECTION OF DRUG RESISTANCE MUTATIONS IN CHRONIC MYELOID LEUKEMIA STUDY IN JOURNAL OF CLINICAL ONCOLOGY HIGHLIGHTS RESULTS OMAHA, Neb., June 20 /PRNewswire-FirstCall/ -- Transgenomic Inc. (Nasdaq: TBIO) announced today the publication of a study demonstrating the ability of its WAVE System to enable detection of mutations in the BCR-ABL gene that are associated with development of resistance to imatinib therapy in Chronic Myeloid Leukemia (CML) patients. Importantly, in three out of nineteen patients harboring BCR-ABL mutations, the mutations were detectable 1-2 months from the onset of therapy only by denaturing HPLC performed with the WAVE system, but were not detectable by direct DNA sequencing. Since all but four patients with mutations had sustained hematologic responses to imatinib at the time of mutation detection, early mutation screening may serve to identify patients at risk of developing drug resistance. Dr. Giovanni Martinelli (Institute of Hematology and Medical Oncology, University of Bologna, Italy) and colleagues described this work in an article entitled "ABL Mutations in Late Chronic Phase Chronic Myeloid Leukemia Patients with Up-Front Cytogenetic Resistance to Imatinib are Associated with a Greater Likelihood of Progression to Blast Crisis and Shorter Survival: A Study by the GIMEMA Working Party on Chronic Myeloid Leukemia", by Soverini et al, which was published in the Journal of Clinical Oncology on June 20. Dr. Martinelli commented on the significance of this body of work and the role of the WAVE System. "As many as 40% of late chronic phase patients fail to reach a major cytogenetic response while receiving imatinib therapy. Our results suggest that within the non-responder population, the presence of BCR-ABL mutations may identify a subset of patients with a particularly poor prognosis. In addition, our data suggest that denaturing HPLC performed on the WAVE System offers a valuable approach for the early detection of mutations likely to lead to imatinib resistance." Collin D'Silva, Transgenomic's CEO, said, "The important work by Dr. Martinelli's group provides an excellent example of efforts to relate molecular mechanisms of disease to patient outcomes. We believe our WAVE System addresses an increasing need for early detection of molecular events that predict clinical outcomes to facilitate patient-specific disease management. The work of Dr. Martinelli's group represents a significant step towards realizing this goal." About Transgenomic Transgenomic is a global company that provides versatile and innovative products and services to the medical research and pharmaceutical markets. Transgenomic's WAVE Systems are specifically designed for use in genetic variation detection. They have broad applicability to genetic research and molecular diagnostics. The emerging pursuit of personalized medicine is driving the ongoing need to detect new, uncharacterized mutations and genetic polymorphisms. The high analytical sensitivity of the WAVE System makes it a uniquely enabling technology for the advancement of personalized medicine. To date there have been over one thousand systems installed in over 30 countries around the world. In addition to the sale of systems and consumables Transgenomic provides services to pharmaceutical and biopharmaceutical companies in preclinical and clinical development of targeted therapeutics. For more information about the innovative genomics research tools developed and marketed by Transgenomic, please visit the company's Web site at www.transgenomic.com. Forward-Looking Statement Certain statements in this press release constitute "forward-looking statements" of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to management's current views and estimates of future economic circumstances, industry conditions, company performance and financial results. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic's reports to the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law. SOURCE Transgenomic Inc. -0- 06/20/2005 /CONTACT: Mitchell L. Murphy, +1-402-452-5418, mmurphy@transgenomic.com, or Robert J. Pogulis, Ph.D., +1-845-782-9617, rpogulis@transgenomic.com, both of Transgenomic Inc.; or Investors, Paul G. Henning of Cameron Associates, +1-212-554-5462, phenning@cameronassoc.com, for Transgenomic Inc./ /Web site: http://www.transgenomic.com / - - -----END PRIVACY-ENHANCED MESSAGE-----