Aiming to file a new drug application within the next three years, Salmedix Inc. began what the company expects will be among several registration-supporting trials in a Phase II/III program with its cancer drug SDX-105 (bendamustine) against relapsed non-Hodgkin's lymphoma.
"It's a multifunctional alkylating agent" with mechanisms of action that go beyond the traditional ones, said Wendy Johnson, senior vice president of corporate development for San Diego-based Salmedix.
Having been on the market in Germany for decades, SDX-105 is used to treat NHL, chronic lymphocytic leukemia, multiple myeloma, breast cancer and other solid tumors.
SDX-105 was licensed by Salmedix in North America from Munich, Germany-based Fujisawa Deutschland GmbH.
"It took me about a year to do the deal, and they've been incredibly forthcoming," Johnson told BioWorld Today. "We never would have been able to move it forward without the data from Germany," which also will be used in the new drug application.
The Phase II study now starting is designed to evaluate SDX-105 in patients with indolent NHL who are resistant to treatment with Rituxan (rituximab), the widely used NHL drug from South San Francisco-based Genentech Inc. and IDEC Pharmaceuticals Inc., of San Diego. Up to 72 patients will be enrolled at about 20 centers in the U.S. and Canada.
"We chose to start with a Phase II program in order to let physicians use the drug and have knowledge of the drug," Johnson said. "A lot of companies would say it's a Phase II/III [trial], but we're a quiet, conservative company," she added.
People with indolent NHL, also referred to as low-grade or slowly progressing NHL, make up about half the total population with the disease - more than 50,000 new cases of which will occur in the U.S. this year, according to the Leukemia and Lymphoma Society.
Salmedix plans to investigate SDX-105 as a therapy against a variety of other hematologic cancers for which there are encouraging clinical data. Also in the clinical pipeline is SDX-101 for CLL. A multicenter, multinational Phase Ib/II study was recently completed with the drug, which is a component of a drug already marketed for non-oncology indications.
"The drug that's on the market is a nonsteroidal anti-inflammatory drug, but SDX-101 does not have [cyclo-oxygenase (COX)-inhibiting] activity," Johnson said. "It was discovered by serendipity that the lowered lymphocyte counts in people with CLL. We've done two clinical trials, and a third will start early next year." (See BioWorld Today, June 21, 2002.)
Also in a Phase II trial is SDX-102 (L-alanosine), which has undergone previous testing against cancer and is being researched as a potential therapy for non-small-cell lung cancer, pancreatic cancer, sarcoma and mesothelioma.
"It was tested many years ago by the National Cancer Institute," Johnson said, noting that the drug "was very active in preclinical models, but when put in the clinic really did not show sufficient activity to take it forward."
Salmedix, however, has found a subset of patients "who have a particular homozygous gene deletion, and we've developed a diagnostic test to identify those patients. It's like Herceptin. The difference is you're not looking for the protein, you're looking for the absence of the protein."
Herceptin (trastuzumab), from South San Francisco-based Genentech Inc., is a breast cancer drug that sold $109.1 million in the second quarter. The treatment targets patients known to overexpress the HER2 oncogene.