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Studies of Nipent(R) in Combination Cancer Therapies for Treatment of Chronic
Lymphocytic Leukemia and Graft-versus Host Disease (GVHD) Presented at American
Society of Hematology Annual Meeting
DUBLIN, Calif., Dec. 9 /PRNewswire-FirstCall/ -- SuperGen, Inc. (Nasdaq: SUPG) announced that abstracts from five studies of its anticancer drug Nipent® (pentostatin for injection) will be presented this week during the proceedings of the 47th American Society Hematology (ASH) Annual Meeting in Atlanta, Georgia. In addition, five other related abstracts appear in the November issue of Blood.
The five abstracts, which will be presented during the General Poster Sessions, discuss the investigational use of Nipent in combination with other chemotherapeutic agents, to treat chemotherapy-naïve B-cell Chronic Lymphocytic Leukemia and steroid-refractory graft-versus-host disease (GVHD). A combination regimen of pentostatin, cyclophosphamide and rituximab (PCR) is suggested to have comparable activity to fludarabine, cyclophosphamide, and rituximab (FCR) but may be better-tolerated and less toxic in patients with previously treated B-cell chronic lymphocytic leukemia. The response frequencies were virtually identical in both treatment groups with responses seen in 75% of PCR treated patients and 73% of FCR treated patients and a complete response (CR) achieved in 25% in both studies. In terms of toxicity, however, PCR compares favorably to FCR in the following categories: Grade 3/4 neutropenia PCR 53% versus FCR 81% (P=0.0007), thrombocytopenia PCR 16% versus FCR 34% (P=0.04), anemia PCR 9% versus FCR 24% (P=0.06), and grade 3/4 infections (including fever of unknown origin) PCR 28% versus FCR 47% (P=0.05).
In addition, abstracts will be presented that suggest that pentostatin may be beneficial in the treatment of children and adolescents with chronic graft versus host disease (cGVHD). The therapy was well-tolerated with infections, such as mucormycosis, pneumonia, disseminated fungal infection and fungal pneumonia, being the main concern.
All ten of the abstracts referring to pentostatin are available online at http://www.hematology.org and appear in Blood, Volume 106, issue 11, November 16, 2005.
Nipent® is currently approved as a single-agent treatment for patients with hairy cell leukemia and is not approved as either a single agent or as part of a combination regimen for treatment for any other indication.
1. Abstract #937 Enhanced Safety and Tolerability of Dose Intensive Pentostatin and Rituximab in Patients with CLL or Low-Grade B-Cell Presentation -- Poster Session I, Saturday, December 10, 2005 at 2. Abstract #1805 Pentostatin in Steroid-Refractory Chronic Graft-Versus Presentation -- Poster Session II, Sunday, December 11, 2005 at 6:00 3. Abstract #2127 Pentostatin, Cyclophosphamide, and Rituximab (PCR) Has Comparable Activity but Appears To Be Better Tolerated Than Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Patients with Previously Treated Chronic Lymphocytic Leukemia Presentation -- Poster Session II, Sunday, December 11, 2005 at 6:00 4. Abstract #2916 Influence of Allele Level HLA Typing on Unrelated Donor (UD) Transplantation for High Risk Myeloid Leukemias Presentation -- Poster Session III, Monday, December 12, 2005 at 5:00 5. Abstract #3671 Nonmyeloablative Allogeneic Stem Cell Transplantation (NST) for Hematologic Malignancies (HM) Using Pentostatin/Low-Dose\ Presentation -- Poster Session III, Monday, December 12, 2005 at 5:00 1. Abstract #4750 A Multi-Center, Open-Label Study To Evaluate the Safety and Efficacy of Pentostatin, Cytoxan, and Rituxan (PCR) in the Treatment of Previously Untreated or Treated Bulky Stage II or Stage 2. Abstract #5024 Combined Therapy with Alemtuzumab and Pentostatin Is Feasible and Effective in T- Lymphoprolifertive Disorders 3. Abstract #5042 Pentostatin Is a Safe and Active Agent in Chronic Lymphocytic Leukemia CLL with Minimal Toxicity 4. Abstract #5045 A Multi-Center, Open-Label Study To Evaluate the Safety and Efficacy of Pentostatin, Cytoxan, and Rituxan (PCR) in the Treatment of Previously Untreated or Treated, Stage III or IV, Low 5. Abstract #5417 Extracorporeal Photopheresis, Pentostatin, and TBI for Reduced-Intensity Preparation: Adaptation of the Tufts Experience at a 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 Nipent® (pentostatin for injection); Mitomycin (generic brand of Mutamycin®); and SurfaceSafe® cleaner. For more information about SuperGen, please visit http://www.supergen.com Contacts:Timothy L. Enns SuperGen, Inc. Tel: (925) 560-0100 x111 E-mail: [email protected] Sharon WeinsteinNoonan RussoTel: (212) 845-4271 E-mail: [email protected]

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