-----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, IJbHDmbK73BJgCrWkYyrwd0lq5z8esuHLrEmLFd9DMfvY3ysYyGocrpQmPC9/l/8 8v6pHaLQ3UL9GFEmENB+dQ== 0000950129-03-005780.txt : 20031120 0000950129-03-005780.hdr.sgml : 20031120 20031120114458 ACCESSION NUMBER: 0000950129-03-005780 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20031120 ITEM INFORMATION: Other events FILED AS OF DATE: 20031120 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ISOLAGEN INC CENTRAL INDEX KEY: 0000357097 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 870458888 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31564 FILM NUMBER: 031014720 BUSINESS ADDRESS: STREET 1: 2500 WILCREST STREET 2: 5TH FLOOR CITY: HOUSTON STATE: TX ZIP: 77042 BUSINESS PHONE: 713-780-4754 MAIL ADDRESS: STREET 1: 2500 WILCREST STREET 2: 5TH FLOOR CITY: HOUSTON STATE: TX ZIP: 77042 FORMER COMPANY: FORMER CONFORMED NAME: AMERICAN FINANCIAL HOLDING INC /DE DATE OF NAME CHANGE: 19960330 FORMER COMPANY: FORMER CONFORMED NAME: AMERICAN FINANCIAL HOLDING INC /CO DATE OF NAME CHANGE: 19921008 FORMER COMPANY: FORMER CONFORMED NAME: VIDTOR COMMUNICATIONS INC DATE OF NAME CHANGE: 19920721 8-K 1 h10829e8vk.txt ISOLAGEN, INC.- NOVEMBER 20, 2003 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 AND EXCHANGE ACT OF 1934 NOVEMBER 20, 2003 Date of Report (date of Earliest Event Reported) ISOLAGEN, INC. (Exact Name of Registrant as Specified in its Charter) DELAWARE 0-12666 87-0458888 (State or Other Jurisdiction of (Commission File No.) (I.R.S. Employer Incorporation or Organization) Identification No.) 2500 WILCREST, 5TH FLOOR, HOUSTON, TEXAS 77042 (Address of principal executive offices and zip code) (713) 780-4754 (Registrant's telephone number, including area code) NOT APPLICABLE (Former name or former address, if changed from last report) ITEM 5. OTHER EVENTS. On November 20, 2003 the Company issued a press release relating to positive results in the United Kingdom. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The reader is advised to read the press release in its entirety. [THE SIGNATURE PAGE FOLLOWS.] SIGNATURE Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ISOLAGEN, INC. Date: November 20, 2003 By: /s/ Jeffrey W. Tomz --------------------------------- Chief Financial Officer EXHIBIT INDEX EXHIBIT NUMBER DESCRIPTION - -------------- ----------- 99.1 Press Release dated November 20, 2003. EX-99.1 3 h10829exv99w1.txt PRESS RELEASE DATED NOVEMBER 20, 2003 EXHIBIT 99.1 THURSDAY, NOVEMBER 20, 2003, 9:00 AM EASTERN TIME PRESS RELEASE SOURCE: Isolagen, Inc. ISOLAGEN SHOWS POSITIVE RESULTS IN THE UK HOUSTON, T.X. - (PRNewswire) - November 20, 2003 - Isolagen, Inc. (AMEX: ILE), a biopharmaceutical company specializing in the development and commercialization of autologous cellular therapy for hard and soft tissue regeneration, is pleased to announce that it has received data from an independent clinical research organization demonstrating positive results from patients treated with the Isolagen Process in the United Kingdom ("UK"). Isolagen collected patient response data from 59 patients randomly chosen from a total of the approximately 400 patients treated to date in the UK with the Isolagen Process. This data was independently analyzed by an independent clinical research organization. The preliminary data analysis shows positive results. The sampling reflects a cross section of all treated patients at all stages of treatment rather than a summary of patients at some fixed time point following administration of treatment. This data will be part of a submission package that will be presented to the United States Food and Drug Administration ("FDA") for a trial design discussion in December of this year. The results indicate that 73% of sampled patients tested demonstrated positive results even in the first two months of therapy while still receiving injections. One hundred percent of the patients tested who received the Isolagen Process treatment for 6 months or longer had positive results. Very few adverse events were reported and these included mild edema and redness at the injection site, which resolved spontaneously. Collection of data is continuing and the patient data will be incorporated into the proposed International Patient registry for FDA regulatory purposes. ABOUT ISOLAGEN, INC. Isolagen, Inc. (AMEX: ILE) is the parent company of Isolagen Technologies, Inc., which was founded in 1995. Isolagen has focused its efforts in the development of autologous cellular technology that has specific applications in cosmetic dermatology and is exploring applications for periodontal disease, reconstructive dentistry and other health-related markets. Autologous cellular therapy is a process whereby a patient's own cells are extracted, reproduced and then reintroduced to the patient for specific cosmetic and medical applications. Unlike other applications for the treatment of dermal defects, Isolagen utilizes only the patient's unique, living cells to produce the patient's own collagen. There is no foreign substance utilized in this treatment protocol. Isolagen's goal is to become the industry leader in the research, development and commercialization of autologous cellular therapy. This press release contains forward-looking statements and general statements relating to the development of autologous cellular therapy that has specific applications in cosmetic dermatology and also relating to the exploration of applications for periodontal disease, reconstructive dentistry and other health-related markets. The discovery and development of applications for autologous cellular therapy are subject to substantial risks and uncertainties. There can be no assurance that Isolagen's clinical trials relating to autologous cellular therapy applications for the treatment of dermal defects or gingival recession can be conducted within the timeframe that Isolagen expects, that such trials will yield positive results, or that additional applications for the commercialization of autologous cellular therapy can be identified and advanced into human clinical trials. These and other factors, including, but not limited to those described in Isolagen's most recent annual report on Form 10-KSB/A filed with the Securities and Exchange Commission, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. Isolagen does not assume any responsibility for updating any forward-looking statements. Isolagen's corporate headquarters are located in Houston, TX. For further information, please see www.isolagen.com. Contact: Isolagen, Inc. Michael Macaluso, CEO 713-780-4754 Jeffrey W. Tomz, CFO 713-780-4754 -----END PRIVACY-ENHANCED MESSAGE-----