Tuesday, December 12, 2006

Drug Pipeline Series, Phase I, 4 Dec - 11 Dec, 2006

Nastech Announces Positive Phase 1 Clinical Results of Insulin Nasal Spray Compared to Exubera® Inhalation Powder and NovoLog(C) Insulin Aspart Injection.



Vernalis plc announced that it has started a Phase I trial of V24343, a CB1 antagonist, as a potential treatment for obesity, type II diabetes and related disorders.



Neose Technologies Presents Positive NE-180 Phase I Clinical Trial Data at American Society of Hematology Annual Meeting, a Novel GlycoPEGylated™ Erythropoietin, Demonstrates Dose-Dependent Activity in a Phase 1, Single Dose, Dose Escalation Study in Normal Human Volunteers". NE-180 is being developed for the treatment of anemia associated with chronic kidney disease, including patients on dialysis and patients not on dialysis, and for the treatment of anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.



OMRIX Biopharmaceuticals Commences Phase 1 Clinical Trial for Fibrin Patch product for the management and rapid control of bleeding including severe bleeding in surgery.



ArQule, Inc. announced the enrollment and successful dosing of the first patient in a Phase 1 clinical trial with ARQ 171, a second-generation compound generated through its Activated Checkpoint Therapy(SM) (ACT) program. Phase 1 data from this compound, together with Phase 2 data from the ongoing ARQ 501 program, will form the basis of a future licensing decision by Hoffmann-La Roche (Roche).



Merck & Co., Inc. and Vertex Pharmaceuticals Incorporated announced results of a Phase I clinical trial for MK-0457 (also known as VX-680), an investigational small molecule inhibitor of Aurora, FLT-3, JAK-2 and BCR-ABL kinases. The study, conducted at The University of Texas M. D. Anderson Cancer Center and Duke University Medical Center, showed that MK-0457 demonstrated clinical activity in select patients with chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL) with the T315I BCR- ABL mutation and also in patients with refractory JAK-2 positive myeloproliferative diseases (MPD).



Novacea, Inc. announced that Phase 1 data of AQ4N (banoxantrone), an investigational anti-cancer prodrug, demonstrated that AQ4N was active and well tolerated when administered to patients with non-Hodgkin's, chronic lymphocytic and Hodgkin's lymphomas.



Dynavax Technologies Corporation announced the initiation of a Phase 1 dose escalation clinical trial of its TLR9 agonist in combination with a standard chemotherapeutic regimen for metastatic colorectal cancer. The enrollment target of the trial is 15 patients, all of whom will have been previously treated for colorectal cancer but had a recurrence of the disease.



Avigen, Inc. announced findings from a Phase I clinical trial for AV650 (tolperisone), an oral therapy intended for the treatment of disabling neuromuscular spasticity and spasm. AV650, a New Chemical Entity (NCE) in the U.S., was found to be well tolerated with no evidence of sedation in this trial.
The Phase I study enrolled 30 healthy adult volunteers at one center in the U.S.



DURECT Corporation announced that it has successfully completed Phase I clinical trials with a new product, DUR-843, which is intended to treat a persistent pain condition. We believe that the persistent pain market remains underserved and that DUR-843 has the potential to provide several advantages over existing pain medications.

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