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Palo Alto, CA, November 19, 2003 — Telik, Inc. (Nasdaq:
TELK) announced positive interim results from a Phase 1-2a clinical
trial of TELINTRA™ (TLK199) in patients with myelodysplastic
syndrome (MDS), a bone marrow disorder characterized by low levels
of white blood cells, red blood cells and platelets and that may
progress to leukemia. The data were presented at the EORTC-NCI-AACR*
Molecular Targets and Cancer Therapeutics Conference in Boston.
Twenty-one MDS patients were enrolled in the dose-escalation trial
at the time of interim analysis. Sixteen patients were evaluable
for safety and efficacy. Five patients were too early to evaluate.
Twelve of the patients (75%) required blood support prior to study
entry. There is no standard therapy for MDS, and many of the patients
had failed prior therapies with agents such as thalidomide and erythropoietin.
Nine patients (56%) had clinically significant improvement in at
least one of the three blood cell lineages (red cells, white cells,
platelets). Three of the nine had improvement in all three cell
lineages and bone marrow response, and two of the nine also had
improvement in two cell lineages. Three of the responding patients
had reduced requirements for blood support, an important clinical
benefit. Five patients (31%) had objective response as defined as
Hematologic Improvement (HI) by MDS response criteria. Durability
of response in both white blood cells and red blood cells in the
longest observed cohort exceeds 4 months. All patients showed an
increase in blood colony forming units measured in blood and bone
marrow after TELINTRATM administration. There was no evidence of
stimulation of CD34 expressing cells. TELINTRA™ treatment
was well-tolerated and dose escalation continues.
“This early evidence of clinically significant responses
suggest that TELINTRA™ may have potential in treating MDS
and other hematologic malignancies characterized by decreased blood
cell production, including chemotherapy-induced bone marrow suppression
and aplastic anemia,” said Gail L. Brown, M.D., senior vice
president and chief medical officer.
CASE REPORTS
A 72 year old male diagnosed with MDS (Refractory Anemia-RA) in
2001. He was initially treated with thalidomide and erythropoietin
with no response. He was transfusion dependent requiring one unit
of blood every week. He began TELINTRATM therapy with significant
increase in this white blood cell levels from 6,700 to 14,700 and
platelet levels from 159,000 to 394,000. His blood transfusion requirements
decreased and bone marrow showed a decrease in abnormal cells. He
received the maximum allowable treatment cycles in the Phase 1 stage
of the study with good response and tolerability.
A 74 year old female was diagnosed with MDS (refractory anemia
with excess blast cells in transformation - RAEB-t) with decreasing
low white blood cell, red blood cell and platelet levels. She was
treated with erythropoietin with no response. She began TELINTRATM
treatment and her blood counts improved with white cell levels increasing
from 3,200 to 6,900 and improvement in platelet levels.
* American Association for Cancer Research — National
Cancer Institute — European Organization for Research and
Treatment of Cancer
About Telik, Inc.
Telik, Inc. of Palo Alto, CA is a biopharmaceutical company working
to discover, develop and commercialize small molecule drugs to treat
serious diseases for which there is significant demand for new therapies.
The company’s most advanced drug development candidate is
TELCYTA™. Telik’s product candidates were discovered
using its proprietary technology, TRAP, which enables the rapid
and efficient discovery of small molecule drug candidates. Additional
information is available at www.telik.com.
You should not rely on forward-looking statements contained in
this press release, including statements regarding our ability to
successfully develop TELINTRA™ for MDS or any other condition,
its tolerability, potential efficacy or market potential. Telik
can give no assurance with regard to these statements. None of our
products have been determined to be safe or effective in humans
or been approved for marketing. Substantial additional testing will
be necessary prior to seeking marketing approval. There can be no
assurance that such trials will accrue sufficient patients, be conducted
with sufficient quality, in a timely manner, have a successful outcome,
or that regulatory approval will be obtained. In addition, we are
reliant on external manufacturing, and any interruption or delay
in drug supply could adversely affect the development program. More
detailed information regarding factors that may cause actual results
to differ materially from the results expressed or implied by statements
in this press release may be found in Telik’s periodic filings
with the Securities and Exchange Commission. Telik assumes no obligation
to update any information in this press release.
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Contact:
Carol DeGuzman
Senior Director, Corporate Communications
Telik, Inc.
Tel 650-845-7728
Email cdeguzman@telik.com
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