Data will be presented from the largest multicenter Phase II studies ever conducted in CML to date, including the effectiveness of Glivec in patients with each phase of CML (chronic phase, accelerated phase and blast crisis) and each phase of Philadelphia chromosome-positive acute lymphoblastic leukemia.

A Phase II Study of STI571, A Tyrosine Kinase Inhibitor, in Patients with Resistant or Refractory Philadelphia Chromosome-Positive Chronic Myeloid Leukemia: Kantarjian H, Sawyers C, Hochhaus A, Guilhot F, Schiffer C, Resta D, Capdeville R, Druker B.

This Phase II, open-label study evaluated STI571 in patients with Philadelphia chromosome-positive (Ph+) CML in whom interferon had failed. Of the 532 patients enrolled, preliminary bone marrow cytogenetic results are available for 388 patients at three months. The findings demonstrated an overall cytogenetic response rate of 37%. Of the responses, 13% were complete (0 Ph+ cells) and 23% were major (<35% Ph+ cells). In 290 patients who had completed six months of therapy at the time of the analysis, preliminary data suggest an overall response rate of 56%. Hematologic results, not currently available, will also be presented at the meeting.

A Phase II Study of STI571 in Adult Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Accelerated Phase: Talpaz M, Silver RT, Druker B, Paquette R, Goldman JM, Reese SF, Capdeville R

This Phase II study includes 234 patients with CML in the accelerated phase. The preliminary response data, as assessed by the investigators, includes 154 patients who have been treated with STI571 for at least 4 weeks. The overall hematological response rate at 4 weeks is 78%, including 22 patients who have achieved a complete response.

A Phase II Study to Determine the Safety and Anti-Leukemic Effects of STI571 in Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Myeloid Blast Crisis: Sawyers C, Hochhaus A, Feldman E, Goldman JM, Miller C, Ben-Am M, Capdeville R, Druker B.

This Phase II, open-label trial includes 262 CML patients in the blast crisis phase. Preliminary data is based on 94 patients, 44 of whom received prior treatment for blast crisis and 50 of whom were untreated. In the previously untreated patients, the overall response rates were 48% and 47% at 4 and 8 weeks of therapy with STI571, respectively. In those who had received prior therapy for blast crisis, the response rates were 38% and 33%, respectively.

"We are pleased with the results we've seen with Glivec thus far. It represents a new approach to cancer therapy by targeting the specific biochemical abnormality associated with certain types of CML and other rare forms of leukemia," said David Parkinson, MD, Vice President, Clinical Research, Novartis Oncology.

In addition to the studies presented at the ASH meeting, two educational programs will focus on CML and the latest findings on Glivec.

Glivec belongs to a new class of antiproliferative agents called signal transduction inhibitors (STIs), which have been shown to have the potential to interfere with intracellular signaling pathways that have been implicated in tumor development. Glivec is molecularly targeted to the specific chromosomal abnormality, called the Philadelphia chromosome, in chronic myeloid leukemia. The abnormal protein and chromosome may also be present, to a lesser extent, in AML and ALL. Some patients with these rare forms of leukemia have been included in the Glivec clinical trials.

Researchers are also investigating the role of Glivec in solid tumors. Novartis recently began a program of small-scale proof of concept studies in selected solid tumors with its agent Glivec, where the biological mechanisms suggest potential activity. These small-scale pilot studies are intended to establish the basis for further studies in clinical trials.

As Glivec is still in clinical development, its safety and efficacy have not yet been established, and clinical trial participants are being closely monitored. In terms of side effects, preliminary results indicate that the agent has been well tolerated to date. Side effects including nausea, muscle cramps, edemas, skin rash, diarrhea, heartburn and headache have been largely mild or moderate in intensity. Fewer than three percent of patients have experienced occurrence of rare but serious side effects such as the potential for liver toxicity, fluid retention syndrome and hemorrhages.

Chronic myeloid leukemia (CML) is one of the four most common types of leukemia. In the United States, there are approximately 20,000-23,000 cases of CML at any given time.

CML is a hematologic stem cell disorder caused by an acquired abnormality in the DNA of the stem cells in bone marrow. The abnormality results in a gene that produces an abnormal protein.

Although researchers do not fully understand what causes this DNA change, they do know that the abnormal protein that results disrupts the bone marrow's normally well-controlled production of white blood cells. This "deregulated" production of white blood cells leads to a massive increase in their concentration in the blood.

CML progresses through three distinct phases: the chronic phase (typically lasting from three to four years), the accelerated phase (typically lasting from three to nine months), and blast crisis (typically lasting from three to six months), which are marked by a progressive increase in the number of white blood cells. As a patient moves through these stages, the disease usually becomes increasingly refractory to therapy and, therefore, more difficult to treat.

This release contains certain "forward-looking statements" relating to the Company's business, which can be identified by the use of forward-looking terminology such as "potential," "expected," "possibilities," "should begin shortly," "preliminarily," "thus far," "will" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of new products expected to be introduced by the Company and anticipated customer demand for such products.

Such statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Some of these are uncertainties relating to the possibility Glivec is not approved, or of unexpected regulatory delays, government regulation or competition in general, as well as factors discussed in the Company's Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Novartis Oncology is a business unit within Novartis Pharma AG in Switzerland as well as Novartis Pharmaceuticals Corporation in the United States. Novartis (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group achieved sales of CHF 25.4 billion (USD 16.9 billion) and invested approximately CHF 3.6 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 66 000 people and operates in over 140 countries around the world.

Source: Novartis

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