• Celsion Corp., of Columbia, Md., reached an agreement with the FDA for a special protocol assessment for its Phase III trial of ThermoDox in liver cancer. The company plans to immediately initiate a 600-patient trial with a primary endpoint of progression-free survival. ThermoDox is a liposomal encapsulation of doxorubicin. Shares of Celsion (AMEX:CLN) rose 85 cents, or 21 percent, to close at $5 on Friday.

• Diamyd Medical AB, of Stockholm, Sweden, submitted an application to the Swedish Medicinal Products Agency seeking clearance to begin a Phase III trial of its Diamyd therapeutic diabetes vaccine. Additional submissions will be sent to other European countries. Last month, a similar request was filed with the FDA. (See BioWorld Today, Dec. 26, 2007.)

• LifeCycle Pharma AS, of Horsholm, Denmark, said interim results from a Phase II trial of the immunosuppressant LCP-Tacro in liver transplant patients indicated that the drug has better bioavailability and pharmacokinetics than Prograf (tacrolimus, Astellas Pharma Inc.). LCP-Tacro is a once-daily tablet version of tacrolimus, while Prograf is twice-daily. Similar interim data were reported last fall from a Phase II trial in kidney transplants. Top-line data from the kidney transplant trial are expected in March, with liver transplant data following in the second quarter. LCP-Tacro is also in a Phase II trial for autoimmune hepatitis.

• Novagali Pharma, of Evry, France, said the FDA has approved its investigational new drug application to conduct a Phase I clinical trial of Nova63035, an ophthalmic injectable emulsion based on Eyeject technology containing a corticosteroid prodrug for the treatment of diabetic macular edema, a severe form of diabetic retinopathy, a common complication of diabetes that affects about 50 percent of patients. The only approved method for treating DME involves laser photocoagulation therapy, which can leave irreversible blind spots in the retina. Patients in the Phase I clinical trial, which will be conducted in the U.S., will be monitored for 12 months following injection.

• StemCells Inc., of Palo Alto, Calif., reported the death of a patient in its Phase I trial of HuCNS-SC cells (purified human neural stem cells) for Batten disease, a neurodegenerative condition also known as infantile neuronal ceroid lipofuscinosis. The patient apparently suffered from a viral infection, and initial findings indicate the death was related to the natural progression of the disease rather than to the drug, although StemCells will continue to investigate the matter. The six-patient trial was already fully enrolled and all patients had been treated.

• Synta Pharmaceuticals Corp., of Lexington, Mass., said it has initiated a second Phase I clinical study of STA-9090, a heat shock protein 90 (Hsp90) inhibitor, with a once-a-week dosing schedule. The firm in November announced the start of a Phase I clinical study of STA-9090 with a twice-a-week dosing schedule. STA-9090 is a synthetic, small molecule Hsp90 inhibitor with a chemical structure unrelated to the Hsp90 inhibitor geldanamycin or its family of related compounds, such as 17-AAG. In preclinical studies, STA-9090 has shown the ability to inhibit multiple kinases with comparable potency to and a broader activity profile than specific kinase inhibitors, such as Gleevec (imatinib, Novartis), Tarceva (erlotinib, Genentech) and Sutent (sunitinib, Pfizer), the company contended. In addition, the firm said, STA-9090 has shown potency 10 to 100 times greater than the geldanamycin family of Hsp90 inhibitors and activity against a wider range of kinases.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., said data from a Phase II trial of glufosfamide in soft tissue sarcoma showed clinical activity but indicated the need for a different dosing regimen to improve the therapeutic index. The company also reported that data from a Phase II trial in ovarian cancer showed a lack of efficacy, leading to a halt on further enrollment or work in this indication. Last year, Threshold halted a Phase II lung cancer trial with glufosfamide, and a Phase III pancreatic cancer trial failed, although positive data emerged from subset analyses. Data from a Phase I solid tumor trial are expected in the coming months, and Threshold said it plans to partner glufosfamide and focus on the Phase I cancer drug TH-302, a hypoxia-activated prodrug (HAP). (See BioWorld Today, Feb. 28, 2007.)

• ThromboGenics NV, of Leuven, Belgium, and its development partner BioInvent International AB, of Lund, Sweden, said they have received approval from the regulatory authorities in Denmark to initiate a Phase I clinical trial of TB-403, a monoclonal antibody that targets the angiogenic placental growth factor (PIGF). TB-403 has demonstrated strong inhibition of PlGF-associated angiogenesis and tumor growth in animal models, without affecting healthy tissues, the firms said. The Phase I clinical study, to be performed in Denmark, is a double-blind and within-group randomized trial testing single doses of TB-403 or placebo at three escalating levels in 16 healthy male subjects. The study will monitor tolerability and safety after three single escalating intravenous doses.

• Trophos SA, of Marseille, France, said that it recently completed the enrollment of the first 90 patients in a Phase IIa clinical trial of its of TRO19622. The randomized, double-blind, placebo-controlled, single-dose study will compare the efficacy of TRO19622 with placebo after six weeks of treatment in 180 patients with painful diabetic neuropathy. The primary endpoint will be symptomatic pain relief as measured on the 11 point Likert scale on daily diary, as well as a number of other pain scales. The trial, being conducted at centers in Germany, Serbia, Croatia and Latvia, is expected to be completed in the first half of 2008, with results available in later this year.