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September 30, 2004 03:02 PM US Eastern Timezone
Salmedix, Inc. Announces the Initiation of Two New Clinical Trials
SAN DIEGO--(BUSINESS WIRE)--Sept. 30, 2004--
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A New Phase II Study of SDX-101 for Chronic Lymphocytic Leukemia, and a Cooperative Group Study of SDX-102 for Brain Cancer |
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Salmedix, Inc. announced today the initiation of two new clinical studies. A new Phase II clinical study of SDX-101, or R-etodolac, for patients with Chronic Lymphocytic Leukemia ("CLL") has begun enrolling patients in Sweden, Germany and the UK, and is expected to begin enrolling in France and Poland in the near future. This study is an open-label, randomized Phase II clinical trial in which 80 patients with CLL will receive a standard chlorambucil regimen alone or in combination with SDX-101 for multiple cycles. Response rate, using standardized response criteria, will be the primary endpoint. Duration of response will also be evaluated.
"In this new study, we are investigating the utility of SDX-101 in combination with chlorambucil, which is currently one of the regimens used as frontline therapy in CLL patients," stated Pratik Multani, MD, VP of clinical development for the company. "The study is based on data from a previous clinical trial of SDX-101 as a single agent which was presented at the 2003 American Society of Hematology annual meeting by Dr. Markus Jensen from the University of Cologne, Germany. In that dose escalation study in patients with CLL, a total of 43 patients in groups of six to eight were treated twice daily with increasing doses of SDX-101 for up to eight weeks. This prior trial demonstrated clinical activity with an acceptable safety profile. A greater than 25% reduction in absolute lymphocyte count, or ALC, was observed in 73% of patients receiving SDX-101 at doses equal to or greater than 1000 mg twice per day. The maximal ALC decline averaged 48% and typically occurred within four weeks of starting treatment. Following cessation of SDX-101 therapy, ALC generally returned to pre-treatment values. The company believes that this return to pre-treatment values suggests the need for longer duration therapy or use of SDX-101 in combination with other agents active in CLL. In this prior eight-week study, SDX-101 was generally well tolerated with the majority of adverse events defined as mild or moderate, defined as Grade 1 or 2."
On September 17, 2004, a Phase I/II clinical study of SDX-102, or l-alanosine, in patients with previously treated brain tumors was initiated by the New Approaches to Brain Tumor Therapy, or NABTT, a consortium funded by the National Cancer Institute. As the sponsor of the trial, Salmedix is providing clinical supplies of SDX-102 and will be responsible for regulatory filings. NABTT will conduct this trial independently under a standard clinical trial research agreement.
Salmedix has another Phase II trial under way with SDX-102 in advanced stage patients with non-small cell lung cancer, pancreatic cancer, mesothelioma, soft tissue sarcoma and osteosarcoma who have generally failed one or two prior drug regimens.
About Salmedix, Inc.
Salmedix is an oncology drug development company with a commercial focus on the treatment of hematologic malignancies, or blood cancers, with three clinical-stage product candidates, Treanda(TM), SDX-101 and SDX-102. Salmedix maintains its corporate headquarters in San Diego, California.
Forward-Looking Statements
Salmedix cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Salmedix that any of its plans will be achieved. Forward-looking statements include statements related to the ability to enroll the patient numbers required for each trial, that future clinical trial results will support prior findings, or that such future clinical trial results will support regulatory approvals required to market a commercial drug. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Salmedix's business including, without limitation, difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products, unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims, the scope and validity of patent protection for its products, competition from other companies, and its ability to obtain additional financing to support its operations. All forward-looking statements are qualified in their entirety by this cautionary statement, as well as the factors disclosed in the Company's filings with the U.S. Securities and Exchange Commission. Salmedix undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
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