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16.05.2005 19:31:00
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Dacogen -Decitabine- Injection Clinical Data Presented at American Soc
Dacogen -Decitabine- Injection Clinical Data Presented at American Society of Clinical Oncology -ASCO- Annual Meeting Updated Interim Results Of A 3-Arm Dosing Study Presented; Phase 3 Data Demonstrate Activity in Patients with MDS
MGI PHARMA, INC. (Nasdaq:MOGN) and SuperGen, Inc. (Nasdaq:SUPG) today provided a summary of the Dacogen(TM) (decitabine) injection presentations made during the American Society of Clinical Oncology (ASCO) Annual Meeting. Interim results from a trial of three different dosing regimens and data from a phase 3 study of Dacogen injection in patients with myelodysplastic syndromes (MDS) were among the data presented, in addition to data from clinical studies of Dacogen injection in solid tumors and advanced melanoma.
Interim Results From The 3-Arm Alternative Dosing Study Demonstrate Activity
Updated interim results of a study designed to compare three different dosing regimens for Dacogen injection were presented in a satellite symposium on Friday, May 13 and also in a poster session on Monday, May 16. In this study, patients with MDS were randomized to receive one of three Dacogen injection regimens every four to six weeks: 1) a 20 mg/m2 intravenous one hour infusion once per day for five days; 2) a 10 mg/m2 one hour intravenous infusion once per day for 10 days; or 3) a 10 mg/m2 subcutaneous dose of Dacogen injection twice per day for five days. The goal of this study is to enroll a total of approximately 95 patients.
Of 63 evaluable patients, the overall response rate was 44%, including a 37% complete response rate and an 8% partial response rate. In the 32 patients treated with 20 mg/m2 intravenous Dacogen infusion once per day for five days, the complete response rate was 47%. For those patients who received a 10 mg/m2 one hour intravenous Dacogen infusion once per day for 10 days, the complete response rate was 29%. The complete response rate for patients who were treated with a 10 mg/m2 subcutaneous dose of Dacogen injection twice per day for five days was 24%. Adverse events were primarily a result of myelosuppression and included fever (5%) and infection (9%). Because the Bayesian design of this study allows enrollment to continue for the arm demonstrating the most promising clinical results, any additional patients who are enrolled in this study will be treated with the five day 20 mg/m2 intravenous infusion regimen.
"The data presented at ASCO provide us with unique insight into potential dosing regimens for Dacogen injection in patients with MDS, as well as its potential utility in the treatment of patients with other cancers," said Lonnie Moulder, president and CEO of MGI PHARMA. "We are encouraged by the results seen to date from Dacogen injection and we look forward to beginning a phase 3 trial in patients with acute myeloid leukemia in 2005."
MDS Phase 3 Results Indicate Activity In Patients With MDS
Additional data from a phase 3 trial of Dacogen injection in patients with MDS were presented on Monday, May 16. A total of 170 patients in this study were randomized to receive Dacogen injection plus supportive care or supportive care alone. Dacogen injection was administered intravenously over three hours at a dose of 15 mg/m2 every eight hours for three consecutive days. The co-primary endpoints of this study were overall response rate and time to acute myeloid leukemia (AML) progression or death. Secondary endpoints included hematologic improvement, duration of response, cytogenetic response rate, transfusion requirements, quality of life, survival, and safety.
The overall response rate (complete responses plus partial responses) for patients treated with Dacogen injection, inclusive of independent and blinded reviews, was 17% with a median response duration of 9.5 months, compared to 0% in the supportive care arm (p less than 0.001). Of those patients treated with Dacogen injection, the complete response rate was 9% and the partial response rate was 8%. In addition, 13% of patients treated with Dacogen injection had hematologic improvement, compared to 7% of patients in the supportive care arm. The response rates for patients classified as High Risk, Intermediate-2, or Intermediate-1 were 13%, 21% and 14%, respectively. Among patients who responded to Dacogen injection, median time to progression or death was 17.5 months compared to 9.8 months for patients who did not respond to Dacogen injection or received only supportive care. All patients who responded to Dacogen injection treatment became or remained transfusion independent and had improved quality of life scores for several parameters, including improvement of global health status, physical functioning, fatigue, and dyspnea. Major cytogenetic responses were observed in 37% of patients treated with Dacogen injection. Of those patients treated with Dacogen injection who had a complete response or a partial response, overall survival was 23.5 months compared to 13.7 months for patients who did not respond to Dacogen therapy or received only supportive care. The primary toxicity associated with Dacogen injection treatment was myelosuppression, including neutropenia, thrombocytopenia, and anemia. The overall incidence of patients who died on study was 14% among those treated with Dacogen injection, compared to 22% for patients receiving only supportive care.
"We are encouraged that the data from the phase 3 Dacogen injection trial continues to mature in a positive fashion," said James Manuso, president and CEO of SuperGen. "We continue to work with both the FDA and the EMEA regarding the ongoing regulatory reviews."
Additional Dacogen Data in Melanoma and Solid Tumors
Results from a phase 1 dosing study of Dacogen injection in combination with doxorubicin and cyclophosphamide were presented on May 16, 2005. The eleven children with relapsed or refractory solid tumors who participated in this study received a 1-hour infusion of Dacogen injection daily for 7 days, followed by a 45 mg/m2 dose of doxorubicin and a 1 g/m2 dose of cyclophosphamide. Dose limiting toxicities observed included neutropenia and thrombocytopenia at a Dacogen injection dose of 10 mg/m2. Results indicate that the maximum tolerated dose of Dacogen injection, when used in combination with doxorubicin and cyclophosphamide, may be 5 mg/m2. Additional studies may be performed to further evaluate the safety and efficacy of Dacogen injection in patients with neuroblastoma.
Interim data from a phase 1 trial of Dacogen injection plus high dose interleukin-2 (IL-2) in patients with melanoma were presented on May 15, 2005. The 14 patients enrolled in this study were diagnosed with cutaneous melanoma, ocular melanoma, or renal cell cancer and received subcutaneous doses of Dacogen injection daily for 5 days on weeks one and two of a 12-week course of therapy. High dose IL-2 was administered as a bolus infusion every 8 hours for a total of 14 doses. Results of this study indicated that the combination regimen of Dacogen injection and high dose IL-2 may have activity in cutaneous and ocular melanoma, and that the two drugs can be administered safely in combination. Grade 4 neutropenia occurred at a dose of 0.25 mg/kg of Dacogen injection, indicating that 0.2 mg/kg may be the maximum tolerated dose in this regimen.
Below is the list of all Dacogen injection abstracts presented at the 2005 ASCO annual meeting:
Abstract Number: 7527
Phase I trial of sequential decitabine plus high-dose interleukin-2 in patients with advanced melanoma
Abstract Number: 8530
A phase I study of decitabine in combination with doxorubicin and cyclophosphamide in the treatment of relapsed or refractory solid tumors: A Children's Oncology Group Study
Abstract Number: 6546
Hypomethylation induction in MDS after treatment with decitabine at three different doses
Abstract Number: 6543
Clinical benefit and survival endpoints from a phase III trial comparing decitabine vs. supportive care in patients with advanced myelodysplastic syndromes
Abstract Number: 6545
Decitabine low-dose schedule (100mg/m2/course) in myelodysplastic syndrome. Comparison of three different dose schedules
About Dacogen Injection
Dacogen injection is an investigational drug that belongs to a class of drugs called hypomethylating agents. In clinical trials, Dacogen injection has demonstrated activity in several hematological malignancies as well as solid tumors.
Dacogen injection is not approved by the United States Food and Drug Administration (FDA) or any other regulatory agencies as a treatment for any indication. Dacogen injection was accepted for review by the FDA and has a Prescription Drug User Fee Act (PDUFA) action date of September 1, 2005. The Marketing Authorization Application (MAA) for Dacogen injection is currently under review by the European Medicines Agency (EMEA).
About MDS
MDS is a cancer of the bone marrow that is often fatal. Some cases of MDS progress to leukemia. According to the Aplastic Anemia and MDS International Foundation (http://aamds.org/), 20,000 to 30,000 new cases of MDS are diagnosed annually in the United States. The number of new cases diagnosed each year is increasing. The average life expectancy for patients diagnosed with MDS is 6 months to 5 years, depending on the severity of the disease.
About SuperGen
Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the acquisition, rapid development and commercialization of therapies for solid tumors, hematological malignancies and blood disorders. SuperGen's product portfolio includes Orathecin(TM) (rubitecan) capsules, an investigational drug intended for the treatment of pancreatic cancer; Nipent(R) (pentostatin for injection); Mitomycin; and SurfaceSafe(R) cleaner. For more information about SuperGen, please visit www.SuperGen.com.
About MGI PHARMA
MGI PHARMA, INC. is an oncology-focused biopharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet needs of cancer patients. MGI PHARMA has a portfolio of proprietary pharmaceuticals, and intends to become a leader in oncology. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride) injection, Kadian(R) (sustained release morphine sulfate capsules), Salagen(R) Tablets (pilocarpine hydrochloride) and Hexalen(R) (altretamine) capsules in the United States. The Company directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information about MGI PHARMA, please visit www.mgipharma.com.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," " expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA's or SuperGen's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause the Companies' results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability of MGI PHARMA's and SuperGen's product candidates to be proven safe and effective in humans, to receive marketing authorization from regulatory authorities, and to ultimately compete successfully with other therapies; continued sales of MGI PHARMA's and SuperGen's marketed products; development or acquisition of additional products; reliance on contract manufacturing; changes in strategic alliances; continued access to capital; and other risks and uncertainties detailed from time to time in the Companies' filings with the Securities and Exchange Commission including its most recently filed Form 10-Q or 10-K. MGI PHARMA and SuperGen undertake no duty to update any of these forward-looking statements to conform them to actual results.
--30--CLR/ms*
Business Editors/Health/Medical Writers
American Society of Clinical Oncology Annual Meeting
ORLANDO--(BUSINESS WIRE)--May 16, 2005--
MGI PHARMA, INC. (Nasdaq:MOGN) and SuperGen, Inc. (Nasdaq:SUPG) today provided a summary of the Dacogen(TM) (decitabine) injection presentations made during the American Society of Clinical Oncology (ASCO) Annual Meeting. Interim results from a trial of three different dosing regimens and data from a phase 3 study of Dacogen injection in patients with myelodysplastic syndromes (MDS) were among the data presented, in addition to data from clinical studies of Dacogen injection in solid tumors and advanced melanoma.
Interim Results From The 3-Arm Alternative Dosing Study Demonstrate Activity
Updated interim results of a study designed to compare three different dosing regimens for Dacogen injection were presented in a satellite symposium on Friday, May 13 and also in a poster session on Monday, May 16. In this study, patients with MDS were randomized to receive one of three Dacogen injection regimens every four to six weeks: 1) a 20 mg/m2 intravenous one hour infusion once per day for five days; 2) a 10 mg/m2 one hour intravenous infusion once per day for 10 days; or 3) a 10 mg/m2 subcutaneous dose of Dacogen injection twice per day for five days. The goal of this study is to enroll a total of approximately 95 patients.
Of 63 evaluable patients, the overall response rate was 44%, including a 37% complete response rate and an 8% partial response rate. In the 32 patients treated with 20 mg/m2 intravenous Dacogen infusion once per day for five days, the complete response rate was 47%. For those patients who received a 10 mg/m2 one hour intravenous Dacogen infusion once per day for 10 days, the complete response rate was 29%. The complete response rate for patients who were treated with a 10 mg/m2 subcutaneous dose of Dacogen injection twice per day for five days was 24%. Adverse events were primarily a result of myelosuppression and included fever (5%) and infection (9%). Because the Bayesian design of this study allows enrollment to continue for the arm demonstrating the most promising clinical results, any additional patients who are enrolled in this study will be treated with the five day 20 mg/m2 intravenous infusion regimen.
"The data presented at ASCO provide us with unique insight into potential dosing regimens for Dacogen injection in patients with MDS, as well as its potential utility in the treatment of patients with other cancers," said Lonnie Moulder, president and CEO of MGI PHARMA. "We are encouraged by the results seen to date from Dacogen injection and we look forward to beginning a phase 3 trial in patients with acute myeloid leukemia in 2005."
MDS Phase 3 Results Indicate Activity In Patients With MDS
Additional data from a phase 3 trial of Dacogen injection in patients with MDS were presented on Monday, May 16. A total of 170 patients in this study were randomized to receive Dacogen injection plus supportive care or supportive care alone. Dacogen injection was administered intravenously over three hours at a dose of 15 mg/m2 every eight hours for three consecutive days. The co-primary endpoints of this study were overall response rate and time to acute myeloid leukemia (AML) progression or death. Secondary endpoints included hematologic improvement, duration of response, cytogenetic response rate, transfusion requirements, quality of life, survival, and safety.
The overall response rate (complete responses plus partial responses) for patients treated with Dacogen injection, inclusive of independent and blinded reviews, was 17% with a median response duration of 9.5 months, compared to 0% in the supportive care arm (p less than 0.001). Of those patients treated with Dacogen injection, the complete response rate was 9% and the partial response rate was 8%. In addition, 13% of patients treated with Dacogen injection had hematologic improvement, compared to 7% of patients in the supportive care arm. The response rates for patients classified as High Risk, Intermediate-2, or Intermediate-1 were 13%, 21% and 14%, respectively. Among patients who responded to Dacogen injection, median time to progression or death was 17.5 months compared to 9.8 months for patients who did not respond to Dacogen injection or received only supportive care. All patients who responded to Dacogen injection treatment became or remained transfusion independent and had improved quality of life scores for several parameters, including improvement of global health status, physical functioning, fatigue, and dyspnea. Major cytogenetic responses were observed in 37% of patients treated with Dacogen injection. Of those patients treated with Dacogen injection who had a complete response or a partial response, overall survival was 23.5 months compared to 13.7 months for patients who did not respond to Dacogen therapy or received only supportive care. The primary toxicity associated with Dacogen injection treatment was myelosuppression, including neutropenia, thrombocytopenia, and anemia. The overall incidence of patients who died on study was 14% among those treated with Dacogen injection, compared to 22% for patients receiving only supportive care.
"We are encouraged that the data from the phase 3 Dacogen injection trial continues to mature in a positive fashion," said James Manuso, president and CEO of SuperGen. "We continue to work with both the FDA and the EMEA regarding the ongoing regulatory reviews."
Additional Dacogen Data in Melanoma and Solid Tumors
Results from a phase 1 dosing study of Dacogen injection in combination with doxorubicin and cyclophosphamide were presented on May 16, 2005. The eleven children with relapsed or refractory solid tumors who participated in this study received a 1-hour infusion of Dacogen injection daily for 7 days, followed by a 45 mg/m2 dose of doxorubicin and a 1 g/m2 dose of cyclophosphamide. Dose limiting toxicities observed included neutropenia and thrombocytopenia at a Dacogen injection dose of 10 mg/m2. Results indicate that the maximum tolerated dose of Dacogen injection, when used in combination with doxorubicin and cyclophosphamide, may be 5 mg/m2. Additional studies may be performed to further evaluate the safety and efficacy of Dacogen injection in patients with neuroblastoma.
Interim data from a phase 1 trial of Dacogen injection plus high dose interleukin-2 (IL-2) in patients with melanoma were presented on May 15, 2005. The 14 patients enrolled in this study were diagnosed with cutaneous melanoma, ocular melanoma, or renal cell cancer and received subcutaneous doses of Dacogen injection daily for 5 days on weeks one and two of a 12-week course of therapy. High dose IL-2 was administered as a bolus infusion every 8 hours for a total of 14 doses. Results of this study indicated that the combination regimen of Dacogen injection and high dose IL-2 may have activity in cutaneous and ocular melanoma, and that the two drugs can be administered safely in combination. Grade 4 neutropenia occurred at a dose of 0.25 mg/kg of Dacogen injection, indicating that 0.2 mg/kg may be the maximum tolerated dose in this regimen.
Below is the list of all Dacogen injection abstracts presented at the 2005 ASCO annual meeting:
Abstract Number: 7527
Phase I trial of sequential decitabine plus high-dose interleukin-2 in patients with advanced melanoma
Abstract Number: 8530
A phase I study of decitabine in combination with doxorubicin and cyclophosphamide in the treatment of relapsed or refractory solid tumors: A Children's Oncology Group Study
Abstract Number: 6546
Hypomethylation induction in MDS after treatment with decitabine at three different doses
Abstract Number: 6543
Clinical benefit and survival endpoints from a phase III trial comparing decitabine vs. supportive care in patients with advanced myelodysplastic syndromes
Abstract Number: 6545
Decitabine low-dose schedule (100mg/m2/course) in myelodysplastic syndrome. Comparison of three different dose schedules
About Dacogen Injection
Dacogen injection is an investigational drug that belongs to a class of drugs called hypomethylating agents. In clinical trials, Dacogen injection has demonstrated activity in several hematological malignancies as well as solid tumors.
Dacogen injection is not approved by the United States Food and Drug Administration (FDA) or any other regulatory agencies as a treatment for any indication. Dacogen injection was accepted for review by the FDA and has a Prescription Drug User Fee Act (PDUFA) action date of September 1, 2005. The Marketing Authorization Application (MAA) for Dacogen injection is currently under review by the European Medicines Agency (EMEA).
About MDS
MDS is a cancer of the bone marrow that is often fatal. Some cases of MDS progress to leukemia. According to the Aplastic Anemia and MDS International Foundation (http://aamds.org/), 20,000 to 30,000 new cases of MDS are diagnosed annually in the United States. The number of new cases diagnosed each year is increasing. The average life expectancy for patients diagnosed with MDS is 6 months to 5 years, depending on the severity of the disease.
About SuperGen
Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the acquisition, rapid development and commercialization of therapies for solid tumors, hematological malignancies and blood disorders. SuperGen's product portfolio includes Orathecin(TM) (rubitecan) capsules, an investigational drug intended for the treatment of pancreatic cancer; Nipent(R) (pentostatin for injection); Mitomycin; and SurfaceSafe(R) cleaner. For more information about SuperGen, please visit www.SuperGen.com.
About MGI PHARMA
MGI PHARMA, INC. is an oncology-focused biopharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet needs of cancer patients. MGI PHARMA has a portfolio of proprietary pharmaceuticals, and intends to become a leader in oncology. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride) injection, Kadian(R) (sustained release morphine sulfate capsules), Salagen(R) Tablets (pilocarpine hydrochloride) and Hexalen(R) (altretamine) capsules in the United States. The Company directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information about MGI PHARMA, please visit www.mgipharma.com.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," " expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA's or SuperGen's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause the Companies' results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability of MGI PHARMA's and SuperGen's product candidates to be proven safe and effective in humans, to receive marketing authorization from regulatory authorities, and to ultimately compete successfully with other therapies; continued sales of MGI PHARMA's and SuperGen's marketed products; development or acquisition of additional products; reliance on contract manufacturing; changes in strategic alliances; continued access to capital; and other risks and uncertainties detailed from time to time in the Companies' filings with the Securities and Exchange Commission including its most recently filed Form 10-Q or 10-K. MGI PHARMA and SuperGen undertake no duty to update any of these forward-looking statements to conform them to actual results.
--30--CLR/ms*
CONTACT: MGI PHARMA, INC. Jennifer M. Davis, 212-332-4381 E-mail: IR@mgipharma.com or Noonan Russo Robert Stanislaro, 212-845-4268 E-mail: robert.stanislaro@eurorscg.com or SuperGen, Inc. Timothy L. Enns, 925-560-0100 x111 E-mail: tenns@SuperGen.com or Noonan Russo Sharon Weinstein, 212-845-4271 E-mail: sharon.weinstein@eurorscg.com
KEYWORD: FLORIDA TRACK INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL TRADESHOW SOURCE: MGI PHARMA, INC.
Copyright Business Wire 2005
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