Oncaspar-IV, pegylated L-asparaginase
Company: Enzon Pharmaceuticals, Inc.
Approved by the Commission of the European Communities for designation as an orphan medicinal product. September 29, 2008.
Company Comments: Oncaspar-IV utilizes an efficient modern process for manufacturing of L-asparaginase, and an improved PEG linker to enhance stability
TM601, synthetic peptide derived from scorpion venom
Company: TransMolecular, Inc.
Initiated in a Phase 1/2 trial for the treatment of adult patients with recurrent malignant glioma, September 29, 2008
Company Comments: TM601 is highly specific and selective in targeting both primary tumors and metastases both in the periphery and in the central nervous system. It targets and binds to receptors expressed on tumor cells.
Zypadhera (Olanzapine Long-acting Injection)
Company: Eli Lilly and Company
European approval recommended by Committee for Medicinal Products for Human Use, European Medicines Agency, announced September 26, 2008
Company Comments: Olanzapine LAI is an investigational formulation that combines Zyprexa (olanzapine), an atypical antipsychotic, with pamoic acid resulting in a salt that sustains the delivery of olanzapine for a period of up to four weeks.
Kuvan (sapropterin dihydrochloride)
Company: Merck KGaA and Merck Serono
Positive opinion by Committee for Medicinal Products for Human Use, European Medicines Agency, announced September 26, 2008
Company Comments: Positive opinion release for Kuvan as an oral treatment for hyperphenylalaninemia (HPA) in patients with phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency.
CTP-347, deuterium-containing serotonin modulator
Company: Concert Pharmaceuticals
Initiates Phase 1 clinical trial, September 25, 2008
Company Comments: Concert intends to evaluate CTP-347 as a non-hormonal treatment for vasomotor symptoms (VMS or hot flashes) in patients with increased risk of adverse effects due to, or contraindicated to using, hormone therapy, as well as in the larger menopausal population.
ARRY-403, small molecule glucokinase activator (GKA)
Company: Array BioPharma Inc.
Preclinical data presented, September 25, 2008
Company Comments: The data showed that in multiple well-established in vivo models of Type 2 diabetes, ARRY-403 was highly efficacious in controlling both fasting and non-fasting glucose, with rapid onset of effect and maximal efficacy within five to eight days.
Alogliptin (SYR-322) and ACTOS (pioglitazone HCl)
Company: Takeda Pharmaceutical Company Limited
Submitted a new drug application to the US Food and Drug Administration, announced September 24, 2008
Company Comments: Contract research organization PPD, Inc. confirmed submission of NDA.
13-valent pneumococcal conjugate vaccine
Company: Wyeth Pharmaceuticals
Initiated Phase 4 adult vaccine trial, announced September 23, 2008
Company Comments: The investigational 13-valent vaccine being evaluated in this trial of 85,000 adults uses Wyeth-pioneered conjugation technology, and is based on the science of PREVENAR (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed).
CPI-613, Altered Energy Metabolism-Directed (AEMD) compound
Company: Cornerstone Pharmaceuticals Inc.
Began dosing patients in safety and early efficacy clinical trial, announced September 24, 2008
Company Comments: CPI-613 and related compounds are well tolerated in several different animal tumor models at doses that significantly exceed the effective anti-tumor doses in these models.
Liraglutide, a once-daily human GLP-1 analog
Company: Novo Nordisk
Data from 52-week Phase 3 study published in The Lancet, announced September 24, 2008
Company Comments: The study showed that liraglutide, when taken alone, produces statistically significant and sustained improvements in blood sugar control in patients with early type 2 diabetes, as compared with glimepiride, a widely used oral anti-diabetic drug.
ORMD 0801, oral insulin capsule
Company: Oramed Pharmaceuticals, Inc.
Initiated Phase 2A trial, September 24, 2008
Company Comments: The trial on Type 1 Diabetic patients follows completion of similar trials on Type 2 diabetic patients, which demonstrated that ORMD 0801 had a good safety profile and was effective in lowering blood glucose levels.
SCH900105 (AV-299), novel, highly potent antibody to hepatocyte growth factor (HGF)
Company: AVEO Pharmaceuticals, Inc.
Initiated a Phase 1 clinical trial, September 23, 2008
Company Comments: HGF is the soluble ligand for the c-Met receptor tyrosine kinase. Preclinical studies have provided strong evidence that signaling through the HGF/c-Met pathway mediates several cellular functions involved in tumor growth and metastasis, such as cell proliferation, angiogenesis, survival, migration, and invasion.
PMX-60056, anticoagulant reversing agent
Company: PolyMedix, Inc.
Initiated dosing in a Phase 1 clinical study, September 23, 2008
Company Comments: PMX-60056, developed for the reversal of both heparin and the LMWHs. PMX-60056 was designed to bind to the pentasaccharide region, which is found on both heparin and LMWH.
ERBITUX (cetuximab)
Company: ImClone Systems Incorporated and Bristol-Myers Squibb Company
Announced five-year overall survival data from Phase 3 study, September 23, 2008
Company Comments: Analysis of these five-year data demonstrate that the addition of ERBITUX to radiation therapy resulted in a significant increase in median overall survival for patients with advanced squamous cell carcinoma of the head and neck, when compared to radiation therapy alone.
KN38-7271, cannabinoid receptor agonist
Company: KeyNeurotek Pharmaceuticals AG
Receives Orphan Drug Designation from Committee for Orphan Medicinal Products, European Medicines Agency, September 22, 2008
Company Comments: KN38-7271 received designation as an Orphan Medicinal Product for the orphan indication moderate and severe closed traumatic brain injury (TBI). It has been tested in an international Phase II study in more than 90 patients since the end of 2006.
APD 405
Company: Acacia Pharma
Initiated Phase 1 study September 22, 2008
Company Comments: APD 405 is anintravenous formulation of a drug now available in tablet form. Acacia has identified a new use for this drug, the prophylaxis and treatment of nausea & vomiting.
TR-701, oral form of oxazolidinone antibacterial drug
Company: Trius Therapeutics, Inc.
Initiated Phase 2 clinical trial, September 22, 2008
Company Comments: The multicenter trial will test the efficacy, safety and tolerability of once-daily doses of 200, 300 and 400 milligrams of TR-701 in complicated skin and skin structure infections (cSSSI) for five to seven days of treatment.
SB1518, small molecule JAK2-selective kinase inhibitor
Company: S*BIO Pte Ltd https://www.sbio.com/main/NEWS.asp
Initiated multi-center Phase 1 clinical trials, September 18, 2008
Company Comments: These trials are ascending dose studies, are expected to enroll up to 60 patients with leukemia and certain types of lymphoma and are designed to determine the maximum tolerated dose and to assess the pharmacokinetics and overall safety profile of SB1518.
Cladribine tablets
Company: Merck Serono
Initiated of Phase 3 clinical trial, September 18, 2008
Company Comments: The trial will evaluate the safety and efficacy of two dosage regimens of cladribine tablets versus placebo in the treatment of patients who have experienced a first clinical event suggestive of MS.
Seasonal Influenza VLP Vaccine
Company: Novavax, Inc.
Initiated Phase 2 clinical trial, September 16, 2008
Company Comments: The Phase IIa randomized, placebo controlled clinical trial will evaluate the safety and immunogenicity of different doses of its seasonal influenza virus-like particle vaccine.
EDP-322, oral antibiotic, MRSA-active Bicyclolide
Company: Enanta Pharmaceuticals
Initiated a Phase 1 trial, September 15, 2008
Company Comments: In preclinical studies, EDP-322 demonstrated strong in vitro activity against hospital-acquired MRSA strains resistant to vancomycin, Zyvox (linezolid), and CUBICIN (daptomycin).
SANCUSO, Granisetron Transdermal System
Company: ProStrakan Group plcFDA approval announced, September 15, 2008
Company Comments: SANCUSO is the first patch to provide up to five consecutive days of control of nausea and vomiting for patients receiving a moderately and/or highly nausea-inducing chemotherapy regimen.
Filed Under: Drug Discovery
