Exelixis Inc., of South San Francisco, said data from a Phase I trial of cabozantinib in patients with advanced solid tumors in lymphoma were published in the Journal of Clinical Oncology. Those results included data showing that, of the 35 patients with measureable medullary thyroid cancer (MTC), 10 (29 percent) achieved partial responses, with five of those showing response at the first radiologic assessment. Seventeen patients (49 percent) experienced a 30 percent or greater decrease in the sum of tumor measurements compared with baseline, and stable disease for at least six months was observed in 25 of the 37 (41 percent) MTC patients, ranging from 6.4 months to 31.1 months. Exelixis is in Phase III testing in MTC and, pending positive results, expects to file a new drug application by the end of this year. Cabozantinib is a dual MET/VEGFR2 inhibitor.

• Juventas Therapeutics Inc., of Cleveland, reported Phase I data showing that lead product JVS-100, which is designed to encode stromal cell-derived factor-1, met its safety endpoints and was tolerated at all doses tested by all 17 patients with targeted New York Heart Association (NYHA) Class III heart failure. At four months post-treatment, patients in the targeted therapeutic dose range have shown clinically relevant and statistically significant median improvements of 36 meters for six-minute walk distance and 22 points in the Minnesota Living with Heart Failure Questionnaire. Nearly half of the patients improved a full NYHA heart class, and no patients worsened in heart class. Echocardiographs demonstrated that the patients' cardiac function stabilized with dose-dependent trends toward improvement in left ventricular end systolic volume and left ventricular ejection fraction. Those data were presented at the American Society of Gene and Cell Therapy meeting in Seattle.

• KemPharm Inc., of North Liberty, Iowa, reported positive results from a Phase I trial of opioid-based drug candidate KP201, showing that it is cleaved in man as predicted, releasing the active pharmaceutical compound, hydrocodone, into the bloodstream at amounts equivalent to the reference listed drug. KP201 also could not be detected in systemic circulation, indicating that minimal additional studies are warranted to determine impact of KP201 exposure on the body. KP201 is composed of hydrocodone chemically bound to a ligand. The company said it expects to be in position to file a new drug application within the next 18 to 24 months.

• Oncothyreon Inc., of Seattle, started a Phase II portion of its ongoing Phase I/II trial of PX-866 in combination with the chimeric monoclonal antibody Erbitux (cetuximab) following successful completion of the Phase I dose-escalation portion. The goal of the Phase II portion is to evaluate the PI3K inhibitor's antitumor activity and safety when administered with Erbitux vs. Erbitux alone. Up to 144 patients will be enrolled, and the primary endpoint is objective response rate based on RECIST criteria.

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., completed patient accrual in its Phase IIc trial of PH-10 in psoriasis. More than 90 subjects have been enrolled, and final subject assessment is expected to be completed in eight weeks. PH-10 is an aqueous hydrogel formulation of Rose Bengal disodium for topical administration.