Company* | Product | Description | Indication | Status (Date) |
| |
||||
CANCER |
||||
Micromet AG | MT103 | Bispecific antibody | B-cell lymphoma | Company started a multicenter Phase I trial (2/13**) |
Oxford Bio- | MetXia and TroVax | Cancer gene therapy products; MetXia delivers the gene CYP2B6 directly to solid tumors, where it generates an enzyme that converts the prodrug cyclophosphamide into its active, cytotoxic form; TroVax is based on a gene for the tumor-associated antigen OBA1 | Breast cancer and colorectal cancer | Company said the products achieved positive interim results from Phase I/II trials (2/27**) |
PhotoCure ASA | Metvix PDT | Photodynamic therapy | Basal cell carcinoma and actinic keratosis | Company received approval in Norway for Metvix PDT (2/1); received marketing authorization in New Zealand (2/8) |
Viragen Inc. | - | Natural interferon | Malignant melanoma | Phase II/III results from a German study indicated the probability of relapse-free survival after five years was doubled in the treated patients (2/28) |
Xenova Group | XR11576 | DNA targeting agent | Solid tumors | Phase I trial began in the Netherlands and the UK (2/5) |
CARDIOVASCULAR |
||||
Actelion Ltd. | Tracleer | Orally active endothelin | Pulmonary arterial hypertension | The European Union's Committee for Proprietary Medicinal Products issued a positive opinion on Tracleer tablets (2/22) |
CENTRAL NERVOUS SYSTEM | ||||
Neurobiological | Memantine by modulating the N-methyl D-aspartate receptor on cell membranes | Oral neuroprotective agent that appears to restore damaged nerve cells and block excitatory signals | Alzheimer's disease | Company was granted approvable status from regulatory authorities in the European Union (2/22) |
INFECTION | ||||
Achillion Pharma- | ACH-126,443 | L-nucleoside antiviral agent administered orally once | Chronic hepatitis B | Company began a Phase II study, which will be conducted in Europe (2/28) |
Cubist Pharma- | Cidecin | Daptomycin for injection | Urinary tract infection caused by Gram- positive bacteria | In an Eastern European Phase II trial, Cidecin was found to be 83% effective in the evaluable population (2/14) |
Gilead Sciences | Viread | Tenofovir disoproxil | HIV infection | The European Medicines Evaluation Agency granted marketing authorization for Viread in the European Union (2/7) |
Immunitor Co.* | V-1 Immunitor | Vaccine | HIV | Study results showed evidence of clinical benefit; the vaccine has been given to more than 50,000 AIDS patients in Thailand (2/7) |
Tibotec-Virco | TMC125 | A next-generation, non-nucleoside reverse transcriptase inhibitor | HIV | Efficacy data from a Phase IIa trial in Europe demonstrated significant antiviral activity in HIV patients infected with NNRTI-resistant virus and failing NNRTI therapy (2/28) |
INFLAMMATION AND PAIN | ||||
Amrad Corp. | AM336 | Synthetic version of the molecule CVID, originally isolated from the venom of a fish-eating species of cone snail from Australia's Great Barrier Reef | Chronic | Company said positive findings from a multicenter Phase I/II trial in Australia led to early completion, and plans more safety studies and a full Phase II trial this year (2/28) |
MISCELLANEOUS | ||||
Discovery Laboratories | Surfaxin | Humanized, synthesized peptide containing surfactant | Acute lung injury | Company was awarded orphan drug product designation in Europe (2/15) |
DOR BioPharma Inc. (AMEX:DOR) | orBec | Beclomethasone | Intestinal graft-vs.-host disease | OrBec received orphan medicinal product designation in Europe (2/28) |
Metabolic Pharmaceuticals Ltd. (Australia; ASX:MBP) | AOD9604 | Injection; human growth hormone | Obesity | Phase IIa results showed significant effects on the weight of the clinically obese participants (2/13**) |
Scil biomedicals GmbH | SMART anti-L-selectin antibody | Humanized compound | Trauma | Company completed enrollment in an international, multicenter Phase II trial (2/13**) |
Transgene | MVA-HPV-IL2 pox virus, to express two human papillomavirus antigens found in HPV 16, the E6 and E7 proteins | Vaccine that uses the MVA vector, a highly attenuated neoplasia | Cervical intraepithelial | Company initiated a Phase II trial at six sites in France (2/28) |
| | ||||
Notes: | ||||
* Privately held | ||||
** Denotes the date the item ran in BioWorld International. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; LSE = London Stock Exchange; OSE = Oslo Stock Exchange; SWX = Swiss Stock Exchange | ||||
