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NCCN Releases Acute Myeloid Leukemia and Chronic Myelogenous Leukemia Chapters of the NCCN Drugs & Biologics Compendium

JENKINTOWN, Pa.--(BUSINESS WIRE)--Feb. 28, 2005--The National Comprehensive Cancer Network (NCCN) announces the release of Chapters 4 and 5 of the NCCN Drugs & Biologics Compendium(TM): Acute Myeloid Leukemia and Chronic Myelogenous Leukemia.


"The NCCN Drugs & Biologics Compendium contains authoritative and definitive information about the appropriate use of drugs and biologics in the care of patients with leukemia - information that decision-makers at insurance and managed care companies and pharmacy benefits managers can use to establish coverage policy," said William T. McGivney, Ph.D., CEO of the NCCN. "With the release of the leukemia chapters, NCCN utilization information adds to a long list of scientific, evaluative products to facilitate decision-making about appropriate cancer care."

The NCCN Drugs & Biologics Compendium outlines the appropriate uses of drugs and biologics in the care of cancer patients, as derived from the NCCN Clinical Practice Guidelines in Oncology(TM) -- recognized and applied nationally as the standard for clinical policy in oncology. Listed uses include FDA-approved indications as well as those beyond FDA labeling. As with the guidelines, the Compendium spans the continuum of cancer care from early stage to advanced stage disease, and from supportive to palliative care.

Oncology care professionals can visit www.nccn.org to access the most up-to-date version of the NCCN Drugs & Biologics Compendium online or to request a free printed copy.

For more information on the NCCN Drugs & Biologics Compendium and other NCCN programs, please contact NCCN at 215-690-0254 or at www.nccn.org.

The National Comprehensive Cancer Network (NCCN), an alliance of 19 of the world's leading cancer centers, is an authoritative source of information to help patients and health professionals make informed decisions about cancer care. Through the collective expertise of its member institutions, the NCCN develops, updates, and disseminates a complete library of clinical practice guidelines.

These guidelines are the standard for clinical policy in oncology. NCCN's complete spectrum of programs emphasizes improving the quality, effectiveness, and efficiency of oncology practice. Programs include: Clinical Practice Guidelines in Oncology(TM), Drugs & Biologics Compendium(TM), Treatment Guidelines for Patients, the Journal of the National Comprehensive Cancer Network, Leukemia Resource Line, educational conferences and symposia for clinicians, Oncology Outcomes Project, Clinical Trials Network, Cancer Case Manager, and collaborations with managed care organizations.

NCCN member institutions include:

-- City of Hope Cancer Center

-- Dana-Farber/Partners CancerCare

-- Duke Comprehensive Cancer Center

-- Fox Chase Cancer Center

-- Huntsman Cancer Institute at the University of Utah

-- Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance

-- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at The Ohio State University

-- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

-- Robert H. Lurie Comprehensive Cancer Center of Northwestern University

-- Memorial Sloan-Kettering Cancer Center

-- H. Lee Moffitt Cancer Center & Research Institute at the University of South Florida

-- Roswell Park Cancer Institute

-- St. Jude Children's Research Hospital/University of Tennessee Cancer Institute

-- Stanford Hospital & Clinics

-- University of Alabama at Birmingham Comprehensive Cancer Center

-- UCSF Comprehensive Cancer Center

-- University of Michigan Comprehensive Cancer Center

-- UNMC Eppley Cancer Center at The Nebraska Medical Center

-- The University of Texas M.D. Anderson Cancer Center

For more information, visit www.nccn.org.

Contacts

National Comprehensive Cancer Network (NCCN)
Susan Sommerville, 215-690-0254


Experts: U.S. Should Triple Cord Blood Supply

Banks In Operation Today Don't Have Centralized Coordination

WASHINGTON - - A group of influential scientists said the United States should triple the amount of blood saved from umbilical cords. Experts at the Institute of Medicine hope a new national cord blood bank will encourage routine saving of the blood, which is now often thrown away.

Umbilical cord blood is rich in stem cells, which have the unique ability to morph into any type of cell. The scientists said if more were available, almost 12,000 people with leukemia, lymphoma, sickle cell anemia and other diseases might be saved every year.

Private banking of cord blood is available, but it's expensive. Although 22 public banks have been established in the United States to collect, store, and distribute donated cord blood, these banks operate without any centralized coordination, according to the IOM report.

Experts said with a wide enough range of different cord blood, most anyone needing stem cells could find a suitable match. IOM committee chairwoman Kristine Gebbie, a nursing professor at Columbia University in New York, said donations shouldn't be hard to get, but many women aren't aware they can do that.

Previous Stories:
November 22, 2004: More Parents Turn To Banking Newborns' Cord Blood
August 20, 2003: Cord Blood Transplant Saves Boy's Life
December 10, 2001: Cord Blood Could Help Fight Cancer


Genasense® Therapy Promising for Relapsed Myeloma

Researchers from the University of Maryland and the National Cancer Institute have reported that a regimen of Genasense (oblimersen sodium, G3139), dexamethasone and thalidomide has significant activity in patients with relapsed multiple myeloma. The details of this phase II study appeared in the June 20, 2005, issue of the Journal of Clinical Oncology .[1]

Genasense is a Bcl-2 antisense oligodeoxynucleotide that is being evaluated for the treatment of multiple myeloma, acute myeloid leukemia and acute lymphoid leukemia. Bcl-2 is a potent inhibitor of apoptosis. Over-expression of this protein in patients with a variety of malignancies is associated with resistance to chemotherapy. Genasense down-regulates Bcl-2 and has been investigated in several hematological malignances where Bcl-2 has been implicated in disease resistance. In vitro studies have suggested that Genasense can down-regulate Bcl-2 activity and inhibit cell viability.

Researchers from Holland evaluated Genasense as a single agent in patients with multiple myeloma who had failed VAD therapy.[2] They reported responses in 7 of 10 patients who had failed prior therapies. Median progression-free survival was 6 months. They also observed that Genasense down-regulated Bcl-2 protein levels in peripheral blood circulating myeloma cells, B cells, T cells and monocytes. Researchers from Ohio University, University of Chicago, the National Cancer Institute and Genta, Inc. have also reported a promising phase I study of Genasense in untreated older patients with acute myeloid leukemia (AML).[3] All received treatment with cytarabine, daunomycin and Genasense. Complete remissions occurred in 14 patients (48%). They suggested that the degree of down regulation of Bcl-2 correlated with response. A randomized trial in older patients with newly diagnosed AML will be performed to determine the contribution of Genasense.

In the current phase II clinical trial, 33 patients with relapsed multiple myeloma were treated with Genasense, dexamethasone and thalidomide. Thirty-one of these 33 patients had failed an autologous stem cell transplant and 15 had failed thalidomide. They observed responses in 55% of patients with 2 complete and 4 near complete responses. Responses were seen in 7 of the 15 who had failed thalidomide therapy. The median duration of response was 13 months. Overall survival was 17 months. These authors also suggest that biologic data Genasense is active against Bcl-2 mRNA. They also suggest that Genasense should be studied in combination with non-immunosuppressive drugs.

Comments: These are better results than would have been expected in this group of patients most of whom had failed an autologous stem cell transplant and almost half had failed thalidomide. However, only a randomized trial can confirm the contribution of Genasense to improved outcomes.

References

--------------------------------------------------------
[1] Badros AZ, Goloubeva O, Rapoport AP, et al. Phase II study of G3139, a Bcl-2 antisense oligonucleotide, in combination with dexamethasone and thalidomide in relapsed multiple myeloma patients. Journal of Clinical Oncology. 2005;23:4089-4099.
[2] Van de Donk NW, de Weerdt O, Veth G, et al. G3139, a Bcl-2 antisense oligodeoxynucleotide, induces clinical responses in VAD refractory myeloma. Leukemia . 2004;18:1078-1084.

[3] Marcucci G, Stock W, Dai G, et al. Phase I study of oblimersen sodium, an antisense to Bcl-2, in untreated older patients with acute myeloid leukemia: pharmacokinetics, pharmacodynamics, and clinical activity. Journal of Clinical Oncology. 2005;23: published ahead of print on April 22, 2005, as 10.1200/JCO .2005.09.118.



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