Non-U.S. Clinical Trials, Regulatory Submissions, Recommendations And Approvals: July 2004
Company* | Product | Description | Indication | Status |
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AUTOIMMUNE | ||||
Amgen Inc. | Enbrel (FDA-approved) | Etanercept; anti-tumor necrosis factor-alpha antibody | Plaque psoriasis | European regulators recommended approval for treating adults with moderate to severe disease for whom other treatments have been inadequate (7/30) |
Centocor Inc. (unit of Johnson & Johnson) | Remicade (FDA-approved) | Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha | Psoriatic arthritis | European regulators recommended approval of expanded label to include treatment, with methotrexate, of active and progressive PA in patients who responded inadequately to other drugs (7/30) |
Y's Therapeutics | YSIL6 | Agent designed to inhibit TNF-alpha and IL-6 production, and to inhibit T-cell proliferation and migration | Rheumatoid arthritis | Plans Phase II trial in Germany to assess safety and clinical effect (7/26) |
CANCER | ||||
Atrix | Eligard (FDA-approved) | Leuprolide acetate for injectable suspension | Prostate cancer | Licensee Sanofi-Synthelabo filed for approval of six-month, 45-mg formulation in Canada (7/19) |
Immuno- | Mepact | Immune system stimulant designed to activate macrophages | Osteosarcoma | The product was granted orphan designation in Europe in that indication (7/8) |
PharmaMar SA* (Spain) | Kahalalide F | Peptides isolated from the Hawaiian mollusk, Elysia rufescens | Non-small-cell lung cancer and melanoma | Began Phase II trials in Europe in each indication to measure response rates and other endpoints (7/19) |
Progen Industries | PI-88 | Anti-angiogenesis drug also designed to inhibit tumor-promoting factors | Primary liver cancer | Asian collaborator Medigene Bio- Technology Corp. began fourth and largest Phase II trial of drug, in 340 patients in Taiwan (7/13) |
SuperGen | Dacogen | Decitabine for injection; a hypomethylating agent | Myelodysplastic syndromes | Published data from Phase II trials involving 170 patients in Europe showed platelet responses in 63% of patients, which correlated with survival (7/9) |
SuperGen | Orathecin (rubitecan) | Topoisomerase-I inhibitor in capsule formulation | Pancreatic cancer | Filed MAA seeking approval in Europe for treating patients who have failed at least one regimen (7/1) |
CARDIOVASCULAR | ||||
AOP Orphan | Thrombo-reductin | Anagrelide-containing medicinal product | Thrombocythemia | The orphan product was approved in Europe; AOP will complete ongoing Phase III Anahydret trial (7/19) |
Biopure Corp. | Hemopure | Oxygen therapeutic consisting of bovine hemoglobin | Blood loss in trauma patients | Began Phase II trial in South Africa to test safety and tolerability in a hospital setting, as well as to assess efficacy parameters (7/28) |
BioTime Inc. | Hextend | Blood plasma volume expander | Blood loss during surgery | Partner CJ Corp. received approval in South Korea, and now will seek pricing approval (7/7) |
Novogen Ltd. (Australia; NVGN) | Trans-NV-04 | Antioxidant that inhibits smooth muscle cell growth in blood vessels | Cardiovascular disease | Began trial in Australia to test safety and tolerability in healthy volunteers at risk of cardiovascular disease (7/6) |
CENTRAL NERVOUS SYSTEM | ||||
Manhattan Pharmaceuticals | -- | Lingual spray formulation of propofol | Sedation | UK Phase I trial in 12 healthy volunteers demonstrated feasibility of oral mucosal delivery (7/14) |
NeuroSearch | NS1209 | Water-soluble, glutamate AMPA antagonist | Long-lasting seizures | Began two Phase II trials in Denmark, Sweden and Finland to test the agent on 60 patients with refractory status epilepticus (7/20) |
INFECTION | ||||
Avant Immuno- therapeutics | Rotarix | Oral, two-dose, live attenuated vaccine developed from a single human strain | Rotavirus infection | Partner GlaxoSmithKline plc got approval in Mexico for preventing gastroenteritis caused by rota- virus infection; it was the first approval of the vaccine (7/15) |
Chiron Corp. | MeNZB | Meningococcal B vaccine designed for strain in New Zealand | Meningococcal | New Zealand regulators approved the vaccine for use there (7/7) |
Intercell AG* | -- | Vaccine based on virus-derived, T-cell-specific peptides formulated with the company's Polyarginine adjuvant | Hepatitis C | Reported positive data from a Phase II trial in interferon/ribavarin non-responders, setting the stage for further Phase II study (7/21) |
Microscience | spi-VEC | Hepatitis B antigen delivered via company's spi-VEC vaccine technology | Hepatitis B | Phase I trial in 30 subjects showed the vaccine was safe and immunogenic (6/29) |
Neutec Pharma | Mycograb | Agent based on naturally occurring antibody against hsp90 | Invasive | Multinational trial in 139 patients showed 84% response rate vs. 48% in placebo group, a statistically significant result (7/12) |
Sinovac Biotech | Healive | Hepatitis A vaccine that is sold in China | Hepatitis A | Filed registration applications in Brazil, Indonesia, Mexico, Malaysia, Pakistan, Philippines, Sri Lanka, Thailand and Vietnam (7/22) |
Tripep AB | AlphaHGA | Agent designed to inhibit the spread of the virus from the infected cell | HIV | Microdosing study showed the agent was orally bioavailable and had kinetic properties (7/21) |
Vertex | Telzir (Lexiva; FDA-approved) | Fosamprenavir calcium; protease inhibitor | HIV | Vertex and GlaxoSmithKline plc gained approval in Europe for use in combination regimens (7/16) |
Viral Genetics | VGV-1 | Thymus nuclear protein | HIV | Trial in China showed decreased viral loads in treatment-naive patients receiving VGV-1 mono- therapy (7/23) |
MISCELLANEOUS | ||||
Amgen Inc. | Mimpara (FDA- approved as Sensipar) | Cinacalcet HCl; oral calcium calcimimetic | Secondary hyperpara- thyroidism | European regulators recommended approving the drug for HPT in chronic kidney disease patients on dialysis and for elevated calcium levels in patients with parathyroid carcinoma (7/29) |
Ascend | Andrin | Transdermal dihydro- | Benign prostate hyperplasia | Began Phase II trial in 100 healthy men in Australia to evaluate safety and efficacy in preventing prostate growth (7/16) |
Cellegy Pharmaceuticals | Rectogesic | Nitroglycerin ointment | Pain from | Said approval in the UK expected in six months, following satisfactory responses to minor issues (7/7) |
Dragon | -- | Recombinant erythropoietin product | Anemia due to renal failure and surgery | The product was approved in Ecuador, the sixth country to grant approval (7/16) |
Genentech | Xolair | Omalizumab; humanized monoclonal antibody to IgE | Asthma | Novartis submitted an application seeking approval in Europe (7/2) |
Insmed Inc. | SomatoKine | Composition of insulin-like growth factor-1 and its primary binding protein, BP3 | Leprechaunism and primary lateral sclerosis | French officials authorized use in an infant with severe insulin resistance, and Italian officials OK'd use in a patient with PLS (7/12) |
IsoTis | Allox | Allogeneic product derived from human cells, in spray formulation | Wound treatment | Phase II trial in 110 patients with hard-to-heal ulcers showed 45% complete wound closure in the drug group vs. 33.3% among con-trols (7/9) |
BioMarin | 6R-BH4 | Enzyme co-factor; the active ingredient in the company's investigational agent | Phenylketonuria | The product was granted orphan status in Europe (7/20) |
Y's Therapeutics | YSTH2 | Agent designed to inhibit T-cell proliferation and migration, and to inhibit matory cytokine production | Asthma | Plans Phase II trial in Germany to Th-2 type and proinflam- assess safety and clinical effect (7/26) |
Notes: | ||||
* Privately held. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||