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SuperGen Announces Additional Data from Phase III Study of Orathecin(TM) in Patients With Advanced Pancreatic Cancer

June 2, 2003

SuperGen Inc. today announced additional data from the company's Phase III clinical study of the investigational drug Orathecin(TM) (rubitecan) capsules as a treatment for refractory or resistant pancreatic cancer. The company had previously announced selected clinical findings from this study that were presented on May 30, 2003, at a satellite symposium prior to the opening of the 39th Annual Meeting of the American Society of Clinical Oncology. The study randomized 409 patients, most of whom had previously failed two or more chemotherapies, to Orathecin or 'best choice'. The primary study end-point was overall survival with secondary end-points of tumor response and time to disease progression. As previously stated, the primary end-point was not met, however both secondary end-points were achieved. The secondary end-points were independent of crossover effect whereas the primary end-point was not.

As previously announced, seven percent (13/196) of patients randomized to Orathecin experienced either a complete or partial tumor response (shrinkage of tumor by 50 percent or more), versus less than 1 percent (1/211) for patients receiving 'best choice'.

Additionally, 20 percent (40/196) of patients randomized to Orathecin achieved stable disease (less than 50 percent tumor growth or shrinkage), versus 8 percent (17/211) for patients receiving 'best choice'. This finding is also statistically significant and independently verified. The total number of patients achieving 'disease control', defined as complete response plus partial response plus stable disease, was 53/196, or 27 percent, versus 18/211, or 9 percent, for 'best choice'.

"In this salvage therapy study, to have 27 percent of patients randomized to Orathecin achieve disease control is very promising. The patients in this study were the sickest of the sick, most having already failed two prior chemotherapy courses," said Karl Mettinger, M.D., Senior Vice President, Chief Medical Officer of SuperGen.

Toxicities were generally manageable for patients with advanced stage pancreatic cancer. Less that 5 percent of patients in either arm discontinued therapy for drug related toxicity. Severe or most frequent adverse events with an incidence greater than 5 percent in patients who received Orathecin versus the 'best choice' included: asthenia (20% vs. 18%), abdominal pain (17% vs. 12%), pain (5% vs. 6%), sepsis (5% vs. 7%), deep thrombophlebitis (5% vs. 5%), nausea (14% vs. 9%), anorexia (6% vs. 10%), diarrhea (9% vs. 5%), vomiting (12% vs. 8%), leucopenia (22% vs. 13%), anemia (16% vs. 9%), thrombocytopenia (9% vs. 10%), dehydration (15% vs. 12%), bilirubinemia (7% vs. 2%) and dyspnea (8% vs. 6%), respectively.

Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the development and commercialization of products intended to treat life-threatening diseases, particularly cancer. The company's web site can be reached at www.supergen.com.

This press release contains 'forward-looking' statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby. Such forward-looking statements include statements regarding expectations about Orathecin(TM) and the anticipated FDA submission. The success of Orathecin could differ materially from those projected in the forward-looking statements as a result of known and unknown risk factors and uncertainties associated with drug development. Such factors include, but are not limited to: risks and uncertainties related to conducting clinical trials, any clinical benefit that Orathecin may have, whether results from the other large scale Orathecin studies currently on-going will be consistent with the results presented here, how quickly study data can be analyzed, whether an NDA will be submitted to, as anticipated or at all, and filed by the FDA, how long the FDA review process will take, and if Orathecin will ever be approved by the FDA and reach the market. Reference is made to the discussion of risk factors detailed in the Company's filings with the Securities and Exchange Commission, including but not limited to, the report on Form 10-Q for the quarter ending March 31, 2003.

Press Release
SOURCE: SuperGen Inc.

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	Pancreas Cancer News and Archives
		For educational purposes only; not to be relied upon. Please read Pancreatica Disclaimer
	SuperGen Announces Additional Data from Phase III Study of Orathecin(TM) in Patients With Advanced Pancreatic Cancer June 2, 2003 SuperGen Inc. today announced additional data from the company's Phase III clinical study of the investigational drug Orathecin(TM) (rubitecan) capsules as a treatment for refractory or resistant pancreatic cancer. The company had previously announced selected clinical findings from this study that were presented on May 30, 2003, at a satellite symposium prior to the opening of the 39th Annual Meeting of the American Society of Clinical Oncology. The study randomized 409 patients, most of whom had previously failed two or more chemotherapies, to Orathecin or 'best choice'. The primary study end-point was overall survival with secondary end-points of tumor response and time to disease progression. As previously stated, the primary end-point was not met, however both secondary end-points were achieved. The secondary end-points were independent of crossover effect whereas the primary end-point was not. As previously announced, seven percent (13/196) of patients randomized to Orathecin experienced either a complete or partial tumor response (shrinkage of tumor by 50 percent or more), versus less than 1 percent (1/211) for patients receiving 'best choice'. Additionally, 20 percent (40/196) of patients randomized to Orathecin achieved stable disease (less than 50 percent tumor growth or shrinkage), versus 8 percent (17/211) for patients receiving 'best choice'. This finding is also statistically significant and independently verified. The total number of patients achieving 'disease control', defined as complete response plus partial response plus stable disease, was 53/196, or 27 percent, versus 18/211, or 9 percent, for 'best choice'. "In this salvage therapy study, to have 27 percent of patients randomized to Orathecin achieve disease control is very promising. The patients in this study were the sickest of the sick, most having already failed two prior chemotherapy courses," said Karl Mettinger, M.D., Senior Vice President, Chief Medical Officer of SuperGen. Toxicities were generally manageable for patients with advanced stage pancreatic cancer. Less that 5 percent of patients in either arm discontinued therapy for drug related toxicity. Severe or most frequent adverse events with an incidence greater than 5 percent in patients who received Orathecin versus the 'best choice' included: asthenia (20% vs. 18%), abdominal pain (17% vs. 12%), pain (5% vs. 6%), sepsis (5% vs. 7%), deep thrombophlebitis (5% vs. 5%), nausea (14% vs. 9%), anorexia (6% vs. 10%), diarrhea (9% vs. 5%), vomiting (12% vs. 8%), leucopenia (22% vs. 13%), anemia (16% vs. 9%), thrombocytopenia (9% vs. 10%), dehydration (15% vs. 12%), bilirubinemia (7% vs. 2%) and dyspnea (8% vs. 6%), respectively. Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the development and commercialization of products intended to treat life-threatening diseases, particularly cancer. The company's web site can be reached at www.supergen.com. This press release contains 'forward-looking' statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby. Such forward-looking statements include statements regarding expectations about Orathecin(TM) and the anticipated FDA submission. The success of Orathecin could differ materially from those projected in the forward-looking statements as a result of known and unknown risk factors and uncertainties associated with drug development. Such factors include, but are not limited to: risks and uncertainties related to conducting clinical trials, any clinical benefit that Orathecin may have, whether results from the other large scale Orathecin studies currently on-going will be consistent with the results presented here, how quickly study data can be analyzed, whether an NDA will be submitted to, as anticipated or at all, and filed by the FDA, how long the FDA review process will take, and if Orathecin will ever be approved by the FDA and reach the market. Reference is made to the discussion of risk factors detailed in the Company's filings with the Securities and Exchange Commission, including but not limited to, the report on Form 10-Q for the quarter ending March 31, 2003. Press Release SOURCE: SuperGen Inc.

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