Anthera Pharmaceuticals Inc., of Hayward, Calif., said the data and safety monitoring board voted that the phase III SOLUTION study of Sollpura in cystic fibrosis patients with exocrine pancreatic insufficiency continue without modification after completing its first pre-planned safety review of the trial. Sollpura is designed as a soluble, stable and non-pig-derived pancreatic enzyme replacement therapy.

Armo Biosciences Inc., of Redwood City, Calif., said clinical safety and efficacy data on its lead investigational immuno-oncology drug, AM0010 (pegylated Interleukin-10), in patients with advanced solid tumors has been published in the Journal of Clinical Oncology. In a phase I study, 51 patients with advanced solid tumors were treated with AM0010 monotherapy, first in a dose-escalation study and subsequently in a dose-expansion cohort in patients with renal cell cancer (RCC). The primary endpoint was safety and secondary endpoints included objective tumor responses, progression free survival and immune activation. AM0010 led to systemic immune activation with elevated immune stimulatory cytokines and a reduction in the immune suppressive cytokine TGF-beta in the serum. It was well-tolerated in that heavily pretreated patient population who had failed a median of four prior therapies for metastatic resistant or refractory disease. Partial responses were observed in one patients with uveal melanoma and in four of the 15 (27 percent) evaluable RCC patients treated at 20 mcg/kg.

CASI Pharmaceuticals Inc., of Rockville, Md., said its phase II trial of ENMD-2076 in fibrolamellar carcinoma has met its stage I endpoint of objective response for non-futility based on the pre-specified interim analysis criteria and will advance to stage II development.

Collegium Pharmaceutical Inc., of Canton, Mass., said an article published in Current Medical Research and Opinion included results from multiple in vitro studies and clinical pharmacokinetic studies demonstrating that Xtampza ER (oxycodone extended-release), an abuse-deterrent, extended-release opioid, can be administered by sprinkling on to soft food, administering the capsule contents through enteral tubes (nasogastric and gastrostomy) or crushed/chewed without affecting the drug release profile of the formulation. The results suggest that Xtampza ER could provide a treatment option, especially in those patients who have dysphagia or an aversion to swallowing tablet formulations and for whom alternative therapies are not a viable therapeutic option.

Millendo Therapeutics Inc., of Ann Arbor, Mich., said it started a phase IIb trial of oral candidate MLE4901, a nonhormonal therapy for treating polycystic ovary syndrome (PCOS). The double-blind, randomized, parallel-group, placebo-controlled study will test the drug, an antagonist of the neurokinin 3 receptor, in PCOS patients over a seven-month dosing period. The primary endpoint will assess its impact in improving menstrual regularity in women with amenorrhea or oligomenorrhea resulting from PCOS.

Oncosec Medical Inc., of San Diego, said research published in the Journal of Clinical Investigation showed that partially exhausted CD8-positive cells infiltrating melanoma tumors accurately predicted most patients' responses to anti-PD-1 therapies. Findings showed that the response to Keytruda (pembrolizumab, Merck & Co. Inc.) strongly correlated to the percent of CD8-positive tumor-infiltrating lymphocytes that expressed high levels of both PD-1 and CTLA-4. That exhaustion marker is currently being used to select patients for the ongoing phase II investigator-sponsored trial evaluating the combination of Oncosec's investigational therapy, Immunopulse IL-12, and Keytruda in patients with unresectable metastatic melanoma.

Radius Health Inc., of Waltham, Mass., said results from the phase III ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial were published in the Journal of the American Medical Association. The study enrolled 2,463 patients to evaluate the safety and efficacy of abaloparatide for the treatment of postmenopausal women with osteoporosis. Results showed that patients treated with daily abaloparatide for 18 months had a significantly greater reduction in the incidence of new vertebral fractures (p < 0.001) and nonvertebral fractures (p = 0.049) compared to placebo. The drug is under FDA review. (See BioWorld Today, Dec. 22, 2014.)

Regen Biopharma Inc., of San Diego, said the Pan Am Cancer Treatment Center in Tijuana, Mexico, which has a nonexclusive license to test Hemaxellerate in a first-in-human proof-of-concept study, presented interim data on the first five patients with chemotherapy-induced bone marrow suppression, showing all tolerated Hemaxellerate with no side effects. At one month post treatment, two patients (40 percent) had dramatic increases in their circulating white blood cells to levels even above the normal range, and two other patients had their white blood cells return to the normal range. Those patients continued to benefit, and all five patients showed increased number of white blood cells after three months. Four of five patients also had increased numbers of red blood cells, and all patients had increased numbers of platelets three months after treatment compared to after one month. Hemaxellerate comprises cells extracted from a patient's own fat tissue and processed to induce a biological response in the patient that heals damaged bone marrow and restores the body's ability to generate healthy blood cells. The product has received FDA clearance for phase I testing in aplastic anemia patients.

Repros Therapeutics Inc., of The Woodlands, Texas, provided a six-month update on results from its ongoing 15-month study of secondary hypogonadal men in which diet and exercise alone is compared to diet and exercise in combination with enclomiphene treatment. Using LC/MS/MS assessments for total testosterone (T) and free T, it was determined diet and exercise alone increased total T from a mean of 264 ng/dL at baseline to 368 ng/dL (p = 0.0055) at six months but only raised free T from 55.6 pg/mL to 57.1 pg/mL (p = 0.0802). On the other hand, the 12.5-mg and 25-mg doses of enclomiphene achieved levels of both total T and free T beyond levels reached without the addition of diet and exercise in previous studies. Using LC/MS/MS assessments, the 12.5-mg group exhibited an increase in mean morning T from 298 ng/dL to 723 ng/dL (p = 0.0002) at six months, while mean morning T for the 25-mg group increased from 255 ng/dL to 864 ng/dL (p = 0.0082). All subjects in the first six-month phase were provided a commercially available prepared diet along with enrollment in a health club with a personal trainer. During the second six-month phase, men will continue their current treatment with enclomiphene or placebo but will no longer be provided the commercial diet. Exercise with the assigned trainer will continue during this period. In the last three months of the study, the subjects will no longer receive treatment but will stay enrolled in the health club, though without a trainer.

Viiv Healthcare Ltd., of London, said it started a phase III program to support regulatory filings for a two-drug regimen of Tivicay (dolutegravir) and Epivir (lamivudine) as a treatment of HIV-1 infection in adults who have not received prior antiretroviral therapy. The program will consist of two identical studies – GEMINI 1 and 2 – comparing the two-drug regimen with the three-drug regimen comprising dolutegravir plus Truvada (tenofovir/emtricitabine, Gilead Sciences Inc.). A total of 1,400 HIV patients will be enrolled. Both trials are designed to demonstrate noninferiority, and the primary efficacy endpoint will be measured at week 48. The study will continue to evaluate the long-term antiviral activity, tolerability and safety through week 148.

Vtv Therapeutics Inc., of High Point, N.C., said it completed enrollment in the phase II LOGRA (aLosteric Oral Glp1 Receptor Agonist) study, a randomized, double-blind, placebo-controlled trial testing TTP273, an oral, small-molecule GLP-1 receptor agonist. The trial is assessing the safety and efficacy of TTP273 in type 2 diabetics on stable doses of metformin. The primary endpoint is the change from baseline in HbA1c at three months, with secondary endpoints including body weight, plasma glucose, lipids insulin, lactate, C-peptide, glucagon and GLP. Top-line data are expected late this year.