• Aastrom Biosciences Inc., of Ann Arbor, Mich., said its first patient has been enrolled in the REVIV Phase III trial of ixmyelocel-T, for critical limb ischemia. The trial will evaluate efficacy and safety of ixmyelocel-T, and will ultimately enroll 594 patients with the disorder who have no option for revascularization and no existing tissue loss due to ischemia.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., released final results from a Phase I trial of ALN-TTR01, an RNAi therapeutic for TTR-mediated amyloidosis, showing that use of the drug resulted in statistically significant reductions in serum TTR protein levels in ATTR patients. The trial was a randomized, placebo-controlled, single-dose escalation study. Thirty-two patients in seven cohorts received doses ranging from 0.01 to 1 mg/kg, or placebo. Data were presented at the XIII International Symposium on Amyloidosis, May 6-10.

• Bionor Pharma ASA, of Oslo, Norway, Eurocine Vaccines AB, of Solna, Sweden, and Oslo University Hospital reported that a trial of Bionor Pharma's Vacc-4x and Eurocine Vaccines adjuvant Endocine produced vaccine-related immune responses in a nasal immunization study in human patients. The results showed safety of nasal administration, and additional information regarding dose-related differences and antibody production in mucosal secretions are being gathered.

• Celgene International Sarl, a subsidiary of Celgene Corp., of Summit, N.J., said three Phase III trials of Revlimid (lenalidomide) in multiple myeloma supported the growing body of evidence for use of the drug in newly diagnosed patients and in maintenance treatment following autologous stem cell transplant. The results were published online in the May 10, 2012, edition of The New England Journal of Medicine.

• Clavis Pharma ASA, of Oslo, Norway, reported that partner Clovis Oncology Inc., of Boulder, Colo., received notification from the independent data monitoring committee that 64 percent of the 360 metastatic pancreatic cancer patients enrolled in the pivotal LEAP study testing CP-4126 (also known as CO-101) were classified as hENT1-low. The hENT1-low patients comprise the target population, in which the primary survival endpoint will be assessed. The final hENT1 classification is in line with results reported in January showing that about two-thirds of metastatic pancreatic cancer patients are likely to be hENT1-low. Top-line data from LEAP are expected in the fourth quarter.

• Mucosis BV, of Groningen, the Netherlands, said a Phase I trial provided proof-of-concept that Mimopath-based mucosal vaccines are safe and well tolerated, and able to produce balanced immune responses in circulating blood and the respiratory tract. The trial evaluated safety, tolerability and immunogenicity of nasally administered FluGEM influenza vaccine, in addition to a standard amount of trivalent split influenza antigen. The randomized, blinded, placebo-controlled trial enrolled 60 human subjects between 18 and 49, receiving trivalent split vaccine or FluGEM.

• Onconova Therapeutics Inc., of Newtown, Pa. has advanced the oral formulation of rigosertib (Estybon, ON 01910.Na), an anticancer agent with demonstrated activity in solid tumors and hematologic malignancies, into a new Phase II study. The intravenous formulation of rigosertib is currently in a pivotal Phase III trial for refractory myelodysplastic syndromes (MDS) in the U.S. and EU. The Phase II study follows the positive findings of a Phase I dose escalation study in MDS patients treated with orally administered rigosertib. In that study, orally delivered rigosertib was well tolerated and bioavailable. Clinical activity observed included favorable bone marrow responses in high-risk patients who were refractory to hypomethylating agents, a reduction in need for red blood cell (RBC) transfusions in transfusion-dependent patients, and a transition to transfusion independence. A final analysis of the Phase I trial, along with results from a separate study of oral rigosertib in patients with solid tumors, will be reported at the 2012 American Society of Clinical Oncology meeting, in Chicago next month.

• Seattle Genetics Inc., of Bothell, Wash., said interim results from an investigator-sponsored Phase II trial of Adcetris (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) were presented at the Society for Investigative Dermatology annual meeting in Raleigh, N.C. Adcetris is an antibody-drug conjugate directed to CD30. The trial enrolled CTCL patients with mycosis fungoides (MF) or Sézary syndrome. At the time of data analysis, 17 patients were enrolled, including 16 with MF and one with Sézary syndrome. Patients received a median of six prior therapies, including a median of four prior systemic therapies. The primary endpoint of the trial is clinical response rate. Twelve of 16 evaluable patients (75 percent) achieved a partial remission. Three patients had stable disease, and one patient had progressive disease. One patient was not yet evaluable for response.