BiTE antibody blinatumomab (MT103/MEDI-538)
Company: Micromet, Inc.
Phase 1 clinical study results, announced August 14, 2008
Company Comments: The phase 1 study demonstrated tumor regression, and in some cases, complete remission, in non-Hodgkin’s lymphoma patients who relapsed after previous treatments and were considered to have incurable disease.
REOLYSIN formulation of the human reovirus
Company: Oncolytics Biotech Inc.
U.S. National Cancer Institute (NCI) started enrolment in a Phase 2 clinical trial for patients with metastatic melanoma, announced August 12, 2008
Company Comments: The primary objectives of the study are to assess the antitumor effects of REOLYSIN in patients with metastatic malignant melanoma, as well as the safety profile of REOLYSIN. Secondary objectives include assessment of progression free survival and overall survival.
Company: PolyMedix, Inc.
Initiated Phase I clinical trial, announced August 12, 2008
Company comments: PMX-60056 is an anticoagulant reversing agent, which PolyMedix calls a heptagonist. It is a reversing agent for heparin and the Low Molecular Weight Heparins (LMWH).
Alpharadin (radium-223 chloride)
Company: Algeta ASA
Initiated Phase 1, US trial, announced August 12, 2008
Company Comments: The trial (BC1-08) will be an ascending dose study of Alpharadin in up to 18 hormone-refractory prostate cancer patients. The trial will evaluate the pharmacokinetics and biodistribution of Alpharadin in relation to dose
KUR-212 (Viz.I-020502) platelet-derived growth factor (PDGF) and fibrin combination
Company:Kuros Biosurgery AG
Results of the one-month follow-up of a Phase IIa clinical trial, announced August 11, 2008
Company Comments: The Phase 2a clinical trial assessed the safety and effects on wound closure (full re-epithelialization) of KUR-212 over two separately reported periods of 1 and 12 months respectively. There were no treatment-related adverse events, meeting the primary endpoint (safety) of the study.
Exebryl-1 small molecule drug
Company: ProteoTech Inc.
ProteoTech initiated its Phase 1 human trial, announced August 7, 2008
Company comments: Efficacy data in Alzheimer’s transgenic mice showed Exebryl-1 lowered brain beta-amyloid protein load by greater than 30-50%, correlating with marked improvements in memory in these animals.
ORMD 0801 oral insulin capsule
Company: Oramed Pharmaceuticals, Inc.
Phase 2A clinical trial in Israel results reported, August 6, 2008
Company Comments: ORMD 0801 was well tolerated and effective in lowering blood glucose levels in patients with type 2 diabetes. In six of the nine subjects analyzed, statistically significant reductions in glucose as well as C-peptide were observed.
Tracleer (bosentan) dual endothelin receptor antagonist
Company: Actelion Ltd
Approved in the European Union for the treatment of patients with mildly symptomatic pulmonary arterial hypertension, announced August 5, 2008
Company Comments: Tracleer is the first PAH treatment ever to be investigated in a clinical study that exclusively enrolled patients with mildly symptomatic WHO FC II. This 185-patient randomized, double-blind, placebo-controlled study provided the basis for this EU approval.
HEPLISAV, an investigational hepatitis B virus vaccine
Company: Dynavax Technologies Corporation (Nasdaq:DVAX) and Merck & Co., Inc.
Announced top-line immunogenicity results from a Phase 3 clinical trial, Announced August 5, 2008
Company Comments: This study evaluated a two-dose regimen of HEPLISAV administered at 0 and 1 month compared to a three-dose regimen of Engerix-B® administered at 0, 1 and 6 months. The primary endpoint, the proportion of subjects who developed protective antibodies to hepatitis B after administration, was achieved.
ISENTRESS (raltegravir) integrase inhibitor
Company: Merck & Co., Inc.
Results from ongoing Phase 2 study, announced August 5, 208
Company Comments: ISENTRESS, in combination with two other anti-HIV medicines, reduced HIV viral load to undetectable levels in 83 percent of previously untreated HIV-infected patients.
IMD-026260 anti-cancer drug
Company: InterMed Discovery GmbH
Proof of principle pre-clinical study results reported, August 5, 2008
Company Comments: IMD-026260, fully synthetic small molecule, appears to be an inhibitor of Hypoxia-inducible factor 1 (Hif-1) dependent transcriptional activity. It initially demonstrated very high in vitro efficacy in a broad panel of tumor cell monolayer assays as well as in colony forming assays.
Sutent (sunitinab malate) multi-kinase inhibitor
Company: Pfizer Inc.
Phase 3 clinical trial results reported, August 1, 2008
Company Comments: Sutent is an oral multi-kinase inhibitor approved for the treatment of advanced renal cell carcinoma and gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. In this study, patients treated with Sutent reported experiencing significantly lower severity of symptoms like bone pain and breathlessness, among others, than patients treated with IFN-?.
SGN-70 monoclonal antibody
Company: Seattle Genetics, Inc.
Phase 1 clinical trial started, July 31, 2008
Company Comments: SGN-70 is a humanized monoclonal antibody targeting CD70 that is being developed as an investigational therapy for autoimmune diseases. It has been shown in preclinical models to selectively deplete CD70-positive lymphocytes and block the co-stimulation pathway between CD70 and its receptor, CD27.
Homspera Hsp90 inhibitor
Company: ImmuneRegen BioSciences, Inc.
Announced genotoxicity study results, July 30, 2008
Company Comments: Genotoxicity studies confirming that drug candidate does not cause DNA damage. Homspera acts on adult stem cells by increasing their differentiation into the cells required to regenerate or strengthen the human immune system.
LY2062430 anti-amyloid beta monoclonal antibody
Company: Eli Lilly and Company
Phase 2 study interim results reported, July 30, 2008
Company Comments: LY2062430 is an investigational anti-amyloid beta monoclonal antibody for the treatment of mild to moderate Alzheimer’s disease. Results suggest that by binding to soluble amyloid beta proteins, the antibody may begin to dissolve the amyloid plaques that are present in the brains of patients with Alzheimer’s disease.
Deforolimus mTOR inhibitor
Company: ARIAD Pharmaceuticals, Inc.
Phase 2 clinical trial started, July 30, 2008
Company Comments: Deforolimus, is a novel rapamycin analog that specifically and potently inhibits mTOR, a downstream activator of the PI3K/Akt and nutrient sensing pathways. The study will evaluate oral deforolimus in combination with intravenous Herceptin (trastuzumab) in patients with metastatic, HER2-positive breast cancer who have developed resistance to trastuzumab therapy.
Filed Under: Drug Discovery