Anika Therapeutics Inc., of Bedford, Mass., said data from a study of 40 patients testing its hyaluronan-based scaffold, Hyalofast, used in combination with autologous adult mesenchymal stem cells, to treat patients with cartilage lesions of the knee joint were published in Knee Surgery Sports Traumatology Arthroscopy. Patients older than 45 had similar outcomes as younger patients. The size and quantity of the lesions, rather than age, had the biggest impact on outcomes, results showed.

Cellectar Biosciences Inc., of Madison, Wis., said its lead PDC compound, CLR-131, achieved a median overall survival of 22.5 months to date after a single dose infusion of 12.5mCi/m2 in patients with multiple myeloma. Patients in the first cohort of the company's phase I trial had an average of 5.8 prior lines of treatment and therefore were considered to be heavily pretreated. The fourth cohort is fully enrolled, with patients receiving a single infusion providing a dose of 31.25 mCi/m2, and Cellectar expects to report initial results from that cohort by the close of the third quarter.

Durect Corp., of Cupertino, Calif., said Orient Pharma Co. Ltd., of Taipei, Taiwan, its licensee for certain Asian and South Pacific countries, reported that a phase III study of Oradur-Methylphenidate ER Capsule conducted in Taiwan achieved positive results. Oradur-Methylphenidate is in development for the treatment of attention deficit hyperactivity disorder. For the primary efficacy endpoint, the drug was superior to placebo in a statistically significant manner (p=0.0044 for the intent to treat population and p=0.0032 for the per protocol population). There were no serious adverse events in the pivotal study.

Fate Therapeutics Inc., of San Diego, said the FDA cleared a third IND for FATE-NK100, for testing in women with ovarian cancer resistant to, or recurrent on, platinum-based treatment. FATE-NK100 is composed of adaptive memory NK cells expressing CD57 and the memory-like activating receptor NKG2C. The trial is designed to determine the maximum dose of a single infusion of FATE-NK100 when administered intraperitoneally in the outpatient setting. An accelerated dose-escalation design is intended to test up to three dose levels of FATE-NK100 with one subject enrolled per dose level. A 10-subject expansion cohort is planned at the maximum dose level. Other endpoints include objective response rate at 28 days post-infusion and progression-free and overall survival at six months post-infusion. Fate also reported nonclinical data, published in Cancer Research, demonstrating a GMP-compatible manufacturing process that induces both NK cell expansion and acquisition of CD57, a marker of NK cell maturation. Higher frequencies of CD57-positive NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes.

Humanigen Inc., of Brisbane, Calif., said it completed enrollment and follow-up of subjects in its human bioavailability study for benznidazole. Analysis of the study has begun, and the company anticipates preliminary interpretation of the data by October. The bioavailability study is part of the company's planned NDA package in the 505(b)(2) development program for benznidazole as a potential treatment for Chagas disease, a neglected tropical disease. The study's main objective is to characterize the pharmacokinetic profile of benznidazole.

Kite Pharma Inc., of Santa Monica, Calif., said it submitted an IND to start a phase I trial of KITE-585, a CAR T-cell therapy engineered to target B-cell maturation antigen in patients with relapsed/refractory multiple myeloma.

Mitobridge Inc., of Cambridge, Mass. said it started a phase I trial of its PPAR-delta modulator, MA-0211 (also known as MTB-1), to test the safety, tolerability, pharmacokinetics and pharmacodynamics of MA-0211 in healthy volunteers. Mitobridge plans to eventually test the drug, which is being developed with partner Astellas Pharma Inc., of Tokyo, in patients with Duchenne muscular dystrophy.

Reata Pharmaceuticals Inc., of Irvine, Texas, said it enrolled the first patient in the phase III portion of the CARDINAL trial of bardoxolone methyl in chronic kidney disease caused by Alport syndrome. The purpose of the study is to determine the safety and efficacy of bardoxolone in Alport syndrome patients and to determine if Alport syndrome patients experience improvements in kidney function compared to placebo. (See BioWorld Today, Feb. 24, 2017.)

Selvita SA, of Krakow, Poland, and the Leukemia & Lymphoma Society (LLS) announced a partnership to co-fund further preclinical and clinical development of a targeted therapy to treat patients with acute myeloid leukemia (AML). Selvita discovered and is developing SEL-120, a therapy that targets the cyclin-dependent kinase 8 protein, which plays a role in gene regulation. SEL-120 has shown efficacy in treating AML cells both in vitro and in vivo. Under the terms of the agreement, LLS will provide up to $3.25 million funding over four years, through its Therapy Acceleration Program, in order to help fund further SEL-120 IND-enabling studies and a phase I trial in AML.

Tapimmune Inc., of Jacksonville, Fla., said, in coordination with the FDA, it amended the patient inclusion criteria for its phase II trial of T-cell therapeutic peptide vaccine TPIV-200 to focus on women with stage III and IV ovarian cancer who are in remission following their first round of successful platinum-based chemotherapy. Tapimmune has enrolled the first women under that amended study protocol, which expands the population of patients that can be addressed with TPIV-200 as a potential maintenance therapy designed to prevent disease recurrence. TPIV-200 targets the folate receptor alpha protein, which is overexpressed by most patients with ovarian cancer.