Introgen announces key regulatory advance for Advexin program

By Elaine Rigoli

Tampa, Fla., Aug. 9 - Introgen Therapeutics, Inc. said Wednesday that it reached an agreement with the Food and Drug Administration to incorporate the use of Introgen's biomarkers in the analysis of Advexin clinical data in support of FDA approval of Advexin p53 cancer therapy.

Introgen recently presented prognostic biomarker data identifying patients with statistically significant increased survival and disease control following Advexin therapy.

"The use of Introgen's prognostic biomarkers for clinical data analysis is a key regulatory element in positioning Advexin therapy for FDA approval. We now plan to use the biomarkers to analyze our phase 3 patient data. The FDA has previously told the company that its phase 3 trial data may be used for interim efficacy analyses," said Max Talbott, senior vice president of worldwide commercial development and regulatory affairs, in a news release.

During the quarter, Introgen also advanced its research and development and clinical trial programs. Introgen reported its financial results were in line with expectations and guidance for the quarter ended June 30.

During the quarter, Introgen used cash, cash equivalents and short-term investments of $5.9 million to conduct its operations. Introgen's cash, cash equivalents, marketable securities and short-term investments were $23.4 million at June 30.

Revenue was $98,000 for the quarter ended June 30, compared with revenue of $225,000 for the quarter ended March 31 and $336,000 for the quarter ended June 30, 2005.

Operating expense was $8.2 million for the quarter ended June 30 and $8.8 million for the quarter ended March 31, which includes $1.6 million and $2.2 million, respectively, of expense related to stock options primarily resulting from the implementation of Statement of Financial Accounting Standard No. 123R for "Share-Based Payments."

Operating expense was $7.7 million for the quarter ended June 30, 2005, including $711,000 of expense related to stock options.

Introgen reported a net loss of $7.7 million, or $0.21 per share, for the quarter ended June 30, compared with a net loss of $8.2 million, or $0.22 per share, for the previous quarter ended March 31 and a net loss of $7.1 million, or $0.23 per share, for the comparable quarter ended June 30, 2005.

Introgen reported a net loss of $15.9 million, or $0.43 per share, for the six months ended June 30, compared with a net loss of $13.3 million, or $0.43 per share, for the six months ended June 30, 2005.

Revenue was $323,000 for the six months ended June 30, compared with revenue of $845,000 for the six months ended June 30, 2005.

Operating expense was $17.0 million for the six months ended June 30, which includes $3.8 million of expense related to stock options primarily resulting from the implementation of Statement of Financial Accounting Standard No. 123R, "Share-Based Payments."

Operating expense was $14.8 million for the six months ended June 30, 2005, including $799,000 of expense related to stock options.

Introgen is a biopharmaceutical company based in Austin, Texas.

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