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FDA Accepts Application for Selecta Drug Combination for MPM, Clinical Trial Launches

The National Cancer Institute (NCI) and Selecta Biosciences have joined forces to launch a Phase 1 Clinical Trial that will evaluate the safety and tolerability of a promising new drug combination. The drugs, known as LMB-100 and SVP-Rapamycin, have been studied separately in clinical trials with noted success. Combined, the treatment is known as SEL-403.

“SVP-Rapamycin is Selecta’s proprietary, clinical-stage anti-drug antibody (ADA) prevention and immune tolerance technology,” reports Global Newswire. LMB-100 is a “recombinant immunotoxin that targets mesothelin.” Mesothelin is a protein expressed in nearly all mesotheliomas and pancreatic adenocarcinomas, and a high percentage of other malignancies, including breast, lung, and ovarian cancers.

“Mesothelioma remains one of the deadliest and most challenging-to-treat forms of cancer,” said Raffit Hassan, Principal Investigator on the clinical trial. “Recombinant immunotoxins hold the potential to induce marked anti-tumor activity if anti-drug antibodies are prevented and sufficient cycles of therapy can be administered. We are pleased to get this clinical investigation underway to determine if patients may indeed benefit from a combination therapy consisting of LMB-100 and SVP-Rapamycin.”

The trial is enrolling patients with malignant pleural or peritoneal mesothelioma who have undergone at least one regimen of chemotherapy. Patients will receive up to four treatment cycles, with each treatment cycle consisting of an initial dose of SEL-403 on day one, followed by two doses of LMB-100 alone on days three and five. The study expects to enroll up to 18 patients, and the first patient received the combination therapy in March.

The FDA accepted the investigational new drug application for SEL-403 in January.

About Clinical Trials

Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decision-making. A clinical trial may find that a new strategy, treatment, or device improves patient outcomes, offers no benefit, or causes unexpected harm. All of these results are important because they advance medical knowledge and help improve patient care.

–NHLBI.NIH.gov

If you have been diagnosed with mesothelioma, talk to your doctor about participating in a clinical trial. A new or experimental therapy could be effective in treating your specific type of mesothelioma. Talk to your doctor about clinical trials today.

 

Sources

"About Clinical Trials." National Heart, Lung, and Blood Institute (NHLBI). U.S. Department of Health and Human Services, 2018. Web. 10 Apr. 2018.

"Selecta Biosciences Announces First Patient Dosed in Phase 1 Trial of SVP-Rapamycin and LMB-100 Combination Therapy in Mesothelioma." GlobeNewswire News Room. "GlobeNewswire", 12 Mar. 2018. Web. 10 Apr. 2018.