• Clarus Therapeutics Inc., of Northbrook, Ill., said enrollment has been completed in its pivotal Phase III trial of CLR-610, an oral testosterone (T) replacement therapy. The primary endpoint is the percentage of men who achieve normal serum T levels after administration of CLR-610 for 90 days. The study has enrolled 325 men with low serum T (less than 300 ng/dL) in 30 sites in the U.S. and Germany. Clarus expects trial results in the third quarter.

• Lixte Biotechnology Holdings Inc., of East Setauket, N.Y., said it submitted an investigational new drug application for a Phase I trial of lead cancer drug LB-100, which demonstrated in preclinical models an ability to kill cancer cells by inhibiting cancer cell growth and to enhance the killing of cancer cells via widely used drugs such as temozolomide, doxorubicin and docetaxel. In the Phase I trial, the company anticipates testing LB-100 alone and in combination with a standard cancer drug.

• MedImmune Inc., of Gaithersburg, Md., the biologics arm of AstraZeneca plc, reported results from a retrospective database cohort study of 8,443 high-risk infants receiving Synagis (palivizumab) in Medicaid programs across 12 states, showing that about 67 percent of infants were noncompliant with the drug, and the percentage of respiratory syncytial virus-related hospitalization was significantly higher among noncompliant vs. compliant infants. Data were presented at the Pediatric Academic Societies meeting in Boston.

• Quark Pharmaceuticals Inc., of Fremont, Calif., said it amended its existing exclusive licensing agreement with Pfizer Inc., of New York, which enables Quark to perform a Phase IIa study assessing the effect of PF-655 on visual function in patients with moderate and advanced open-angle glaucoma. The study will be conducted in parallel with an ongoing Phase IIb trial in diabetic macular edema. Under the amended deal, should Pfizer assume development and potential commercialization of PF-655 in either or both indications following a review of the Phase IIa data, Quark will receive option exercise payments and will be eligible to receive development and regulatory milestones specific to each indication, as well as sales milestones and royalties.

• Repros Therapeutics Inc., of The Woodlands, Texas, reported that its Proellex-V, or vaginally delivered Proellex, was well tolerated at all doses, and reliable cessation of menses was induced at doses as low as 3 mg. The study dosed six women diagnosed with uterine fibroids for a period of two weeks to determine steady state pharmacokinetics in order to ensure that overall systemic drug exposure was less than that observed in a previous study (1 mg to 12 mg). Repros is developing Proellex-V, currently in Phase II development, for significant fibroid size reduction and symptom elimination, with the goal of avoiding surgery.The company has commenced enrolling women in the 3-mg and 6-mg arms of the study and has notified the FDA that it will add a fourth cohort at 24 mg to the study. Pending positive data, Repros aims to start Phase III studies late this year or early next year, following an end-of-Phase II meeting with the FDA.

• Ultragenyx Pharmaceutical Inc., of Novato, Calif., said a Phase I study showed that UX001 (sialic acid) was well tolerated in patients with hereditary inclusion body myopathy (HIBM) and demonstrated an expected extended-release profile. UX001 is intended as a substrate replacement therapy for HIBM, a severe, neuromuscular disease caused by sialic acid deficiency. Ultragenyx plans to initiate a Phase II study of UX001 in HIBM patients in the second quarter.