• Alfacell Corp., of Bloomfield, N.J., said the FDA granted orphan drug designation for its lead candidate, Onconase (ranpirnase) for malignant mesothelioma. That designation would guarantee Alfacell seven years of marketing exclusivity upon approval of the drug. Onconase, which previously was granted fast-track status, is in a confirmatory Phase IIIb trial in unresectable malignant mesothelioma.

• Exelixis Inc., of South San Francisco, submitted an investigational new drug application to the FDA for XL418, a multi-kinase inhibitor for the treatment of cancer. In preclinical models, XL418 has been shown to reduce tumor growth and enhance the effectiveness of other drugs by inhibiting protein kinase B (PKB or AKT) and S6 Kinase (S6K), key components of the phosphoinositide-3 kinase (PI3K) signaling pathway. Including XL418, Exelixis now has 11 compounds in or ready to enter the clinic, including four compounds in Phase II, and plans to file at least three more INDs this year. In December, the company filed an IND for MEK kinase inhibitor XL518 and followed it up this month with a $40 million deal with Genentech Inc. for the program.

• Gloucester Pharmaceuticals Inc., of Cambridge, Mass., said it reached an agreement with the FDA under the special protocol assessment process for the design of its planned pivotal trial of romidepsin in patients with peripheral T-cell lymphoma. This single-arm trial will enroll PTCL patients who have progressed or become refractory following systemic therapy.

• Immtech Pharmaceuticals Inc., of New York, completed enrollment in Phase III pivotal trial of pafuramidine maleate, an oral drug candidate, in patients with first-stage African trypanosomiasis. The 250-patient study is designed to compare pafuramidine vs. pentamidine. An interim analysis is expected to be completed in mid-2007. The trial was conducted under a special protocol assessment.

• Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, announced that top-line data from a Phase IIb trial of asthma drug IPL512,602 demonstrated no statistically significant differences between drug and placebo groups due to a high response rate in both groups. The company is reviewing and validating all data and expects to report the full results in two to three weeks. Last week the company raised C$3 million (US$2.54 million) through an offering. Tuesday's news sent the stock (IZP.TO) down 52% to close at 12 cents.

• Light Sciences Oncology Inc., of Seattle, said it reached agreement with the FDA on a special protocol assessment for a Phase III trial comparing use of its Light Infusion Therapy (Litx) with a standard treatment for metastatic colorectal cancer in the liver. The study will test safety and efficacy of the Litx system plus standard chemotherapy to chemotherapy alone in 450 colorectal cancer patients with liver metastases. Endpoints include progression-free survival and overall survival.

• Living Cell Technologies Ltd., of Melbourne, Australia, said its DiabeCell Type I diabetes treatment was approved for a Phase I/IIa trial in Russia designed according to FDA guidelines. DiabeCell is a porcine pancreatic cell product aimed at treating insulin-dependent diabetes by injecting neo-natal pig islet cells into the body to allow the release of insulin. The cells are encased in capsules which prevent the patient's immune system from attacking. The trial will involve six Type I diabetics and is expected to start in the second quarter.

• OctoPlus NV, of Leiden, the Netherlands, initiated a Phase IIa trial with lead product Locteron, a controlled-release formulation of alfa interferon for chronic hepatitis C. The multicenter, randomized, open-label, European trial will enroll 32 treatment-na ve HCV patients for treatment with one of four doses of Locteron combined with ribavirin every two weeks for 12 weeks. The trial will assess viral response, safety and tolerability of Locteron. Results are expected in mid-2007 and will be used to select the optimal dose range for a Phase IIb study. Locteron combines OctoPlus' PolyActive drug delivery technology with Biolex Therapeutics' recombinant alfa interferon product, BLX-883.

• Opexa Therapeutics Inc., of The Woodlands, Texas, admitted the first 75 patients in its 150-patient Phase IIb trial of Tovaxin in multiple sclerosis. The 52-week study will evaluate the efficacy and safety of Tovaxin T-cell vaccination with clinically isolated syndrome and relapse-remitting MS. Enrollment is expected to be completed by midyear.

• ZymoGenetics Inc., of Seattle, initiated a Phase I study of PEG-Interferon lambda (IL-29) in healthy volunteers, as part of the product's clinical development in hepatitis C and other viral diseases. The company said the recombinant PEG-Interferon has demonstrated in vitro viral activity and might result in fewer side effects than the standard of care.