Company: GlobeImmune Inc.
Initiated Phase 1 Clinical Trial with NCI in CEA Over-expressing Cancers, April 16, 2009
Company Comments: The GI-6207-01 study (NCI CTEP #8187) is an open-label, dose-escalation trial. The primary endpoint of the study is the safety and tolerability of escalating doses of GI-6207. Secondary endpoints include levels of CEA-specific T cells, reduction in CEA serum markers, and circulating tumor cells and evidence of clinical benefit.
Onrigin (laromustine) Injection
Company: Vion Pharmaceuticals, Inc.
FDA Accepted Review for Onrigin NDA, April 16, 2009
Company Comments: The NDA is based on the results of an international multi-center pivotal Phase 2 trial of 85 patients sixty years of age or older with de novo poor-risk AML, supplemented by data from 55 patients in a previous Phase 2 trial in elderly AML. Eighty-six percent of these 140 patients had two or more risk factors that predicted for a poor prognosis.
Company: VentiRx Pharmaceuticals, Inc.
Initiated Phase 1 Clinical Trial of VTX-1463, a Novel TLR8 Agonist for the Treatment of Allergic Rhinitis, April 16, 2009
Company Comments: The objectives of this trial will be to assess safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VTX-1463 in approximately 30 healthy volunteers.
Company: Pfizer and Medivation, Inc.
Initiated Phase 3 Trial of Dimebon Added to Donepezil in Patients with Alzheimer’s Disease, April 15, 2009
Company Comment: The study, known as CONCERT, is designed to evaluate the safety and efficacy of Dimebon when added to ongoing treatment with donepezil HCI tablets in patients with mild-to-moderate AD.
Company: Novagali Pharma
Completed a New Phase 2 Clinical Trial With Cyclokat in Dry Eye, April 15, 2009
Company Comments: This phase 2, multi-center, randomized, double-masked, vehicle controlled study of 132 patients evaluated the safety and efficacy of Cyclokat applied once-a-day over three months.
Company: Immutep S.A.
Initiated Phase 1 Clinical Trial of ImmuFact IMP321 in Pancreatic Cancer, April 15, 2009
Company Comments: The phase 1 study is an open-label, two-arm, dose escalation trial in advanced pancreatic cancer treated by first-line gemcitabine alone or associated with increasing doses of IMP321 (3, 6.5, 13, and 26 mg). Investigators will assess the safety and tolerability of this new chemo-immunotherapy combination. The other points to be studied include IMP321’s pharmacokinetics, pharmacodynamics, immunogenicity, a preliminary assessment of anti-tumour activity, as well as the exploration of the molecule’s mechanism of action.
Company: Osprey Pharmaceuticals U.S.A., Inc.
Initiated Phase 1b Clinical Trial in IgA Nephropathy, April 14, 2009
Company Comments: The Phase 1b open-label, dose-escalating study will enroll up to 30 patients diagnosed with IgA nephropathy at clinical sites in Canada. The trial design utilizes a continuous reassessment method to evaluate safety of CCL2-LPM and to establish a maximum-tolerated dose. Secondary endpoints for the Phase 1b clinical trial include an assessment of pharmacokinetics and biomarkers of disease associated with the mechanism of action of CCL2-LPM.
Company: Tekmira Pharmaceuticals Corporation
Filed IND for ApoB SNALP, April 14, 2009
Company Comments: Tekmira Pharmaceuticals Corporation filed an IND application seeking approval from the FDA to begin a Phase 1 human clinical trial to evaluate ApoB SNALP as a treatment for elevated low-density lipoprotein (LDL) cholesterol.
Company: Oasmia Pharmaceutical
FDA Granted Paclical Orphan Drug Designation for Ovarian Cancer in the USA, April 14, 2009
Company Comments: The designation is based on the hypothesis that Paclitaxel is safer than Taxol. Oasmia Pharmaceutical is conducting a Phase 3 study comparing the use of Paclical to Taxol in patients with ovarian cancer. A safety objective is to show the superiority of hypersensitivity reactions.
Company: Cell Therapeutics, Inc.
Initiated Rolling NDA Submission for Pixantrone, April 14, 2009
Company Comments: CTI previously announced that its pivotal phase 3 (PIX 301) EXTEND trial had achieved its primary endpoint with patients randomized to treatment with pixantrone achieving a significantly higher rate of confirmed (CR) and unconfirmed complete remissions (CRu) compared to patients treated with standard chemotherapy (14/70 (20.0 for pixantrone arm compared to 4/70 (5.7 for the standard chemotherapy arm, p 0.02) with no patients in the standard chemotherapy arm achieving a confirmed complete remission.
Company: Centocor Ortho Biotech Inc. and Schering-Plough
Health Canada Approved SIMPONI (golimumab) for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis, April 13, 2009
Company Comments: With this approval in Canada, SIMPONI, in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms in adult patients with moderately to severely active RA; reducing signs and symptoms in adult patients with moderately to severely active PsA, alone or in combination with MTX; and reducing signs and symptoms in adult patients with active AS who have had an inadequate response to conventional therapies.
Company: Tolera Therapeutics, Inc.
FDA Granted Orphan Drug Designation for Organ Transplant Rejection Drug, April 9, 2009
Company Comments: TOL101 is a biologic protein that is designed to safely and specifically target T cells, components of the immune system that play a key role in the rejection, and ultimate failure, of transplanted organs.
Company: Myriad Pharmaceuticals, Inc.
Received IND Approval for New Cancer Drug, April 8, 2009
Company Comments: The Phase 1 trial will assess the safety and pharmacokinetics profile of MPC-3100. In preclinical testing, MPC-3100 has demonstrated potent anti-cancer activity in xenograft models of Her2+ breast cancer, myeloid leukemia, lung cancer, prostate cancer, colon cancer, melanoma, and gastric cancer.
Company: Array BioPharma Inc.
Initiated Clinical Trial in Type 2 Diabetic Patients, April 7, 2009
Company Comments: In the Phase 1 trial, the compound will be evaluated in single- and multiple-dose escalation studies in Type 2 diabetic patients. The study is designed to evaluate safety, tolerability, exposure, and blood glucose control.
Company: Mithridion, Inc.
Phase 1 Study Results in Alzheimer’s Disease, April 7, 2009
Company Comments: The company plans to evaluate the safety, tolerability and pharmacokinetics of MCD-386 in a randomized, double-blind, placebo-controlled, ascending multiple-dose Phase 1 study to commence in the fourth quarter of 2009.
Company: Avineuro Pharmaceuticals, Inc.
Announced Beginning of Phase 1 Clinical Studies of AVN-101, Potent Small Molecule for Treatment of Alzheimer’s Disease, April 7, 2009
Company Comments: The results of Phase 1 studies are expected to be available in May 2009. Based on these and other results, Avineuro Pharmaceuticals, Inc. plans to advance AVN-101 into Phase 2 clinical trials in Q2 2009.
Aplenzin (bupropion hydrobromide)
Aplenzin, a Single Tablet Once-Daily Treatment for Depression at All Doses, Now Available in the United States, April 7, 2009
Company Comments: Aplenzin was approved by the U.S. Food and Drug Administration (FDA) in April 2008.
Company: Watson Pharmaceuticals, Inc.
Announced United States Availability of RAPAFLO (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia, April 7, 2009
Company Comments: In clinical trials, RAPAFLO was proven to rapidly increase urine flow in just two to six hours following the initial dose. In addition, noticeable relief of BPH symptoms was realized in just three to four days, with the majority of patients, including men on concomitant cardiovascular medications, achieving at least a three-point improvement in IPSS score, regardless of age or severity of symptoms.
Company: EPIX Pharmaceuticals, Inc.
Announced Sale of US, Canadian, and Australian Rights for MS-325, April 7, 2009
Company Comments: MS-325 (formerly marketed in the European Union, Canada and Switzerland as Vasovist by Bayer Schering Pharma AG, Germany) is an injectable intravascular contrast agent designed to provide improved imaging of the vascular system through magnetic resonance angiography imaging (MRA).
Company: IntelGenx Corp. and Cary Pharmaceuticals Inc.
Filed NDA for CPI-300 Antidepressant, April 7, 2009
Company Comments: IntelGenx Corp. and Cary Pharmaceuticals Inc. announced that a NDA has been submitted to the US Food and Drug Administration for their antidepressant CPI-300, a new strength of a leading antidepressant that will provide a more convenient dosing option to patients with major depressive disorder.
Company: Theravance, Inc.
FDA Accepted Telavancin NDA for the Treatment of Hospital-Acquired Pneumonia, April 6, 2009
Company Comments: Telavancin is a bactericidal, once-daily injectable investigational antibiotic with a multifunctional mechanism of action.
NUVIGIL (armodafinil) Tablets
Company: Cephalon, Inc.
Announced Positive Results from a Phase 3 Study of NUVIGIL in Jet Lag Disorder, April 6, 2009
Company Comments: The efficacy and safety of NUVIGIL as a potential treatment for acute excessive sleepiness associated with jet lag disorder were evaluated over the course of three days in a randomized, double-blind, placebo-controlled study of 427 healthy adults who had experienced jet lag symptoms during the previous five years.
ZEGERID Table Formulation
Company: Santarus, Inc.
FDA Accepted New Drug Application for ZEGERID Tablet Product, April 2, 2009
Company Comments: Santarus, Inc. announced that the US Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for a new tablet formulation to add to its ZEGERID family of branded prescription pharmaceutical products.