Non-U.S. Clinical Trials And Regulatory Actions: March 2007
Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
AUTOIMMUNE | ||||
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Barrier Therapeutics Inc. (BTRX) | Xolegel | Ketoconazole topical gel | Seborrheic dermatitis | Gained marketing approval in Canada to treat immunocompetent adults and children 12 and older (3/8) |
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Centocor Inc. (unit of Johnson & Johnson) | Remicade (FDA-approved) | Infliximab; monoclonal antibody that targets tumor necrosis factor alpha | Rheumatoid arthritis | Gained European Commission approval of a label extension allowing for greater dosing flexibility, an increased dose in patients who had an incomplete response to initial combination treatment with methotrexate and Remicade (3/2) |
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Centocor Inc. (unit of Johnson & Johnson) | Remicade (FDA-approved) | Infliximab; monoclonal antibody that targets tumor necrosis factor alpha | Crohn's disease | CMPH issued a positive opinion recommending approval for treating severe, active Crohn's disease; it would cover treatment in patients ages 6 to 17 who have not responded to conventional therapies (3/26) |
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CANCER | ||||
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Active Biotech AB (Sweden; SSE:ACTI) | TASQ | An oral agent; tumor angiogenesis suppression by quinolines | Prostate cancer | Phase Ib data showed five of six patients had a decrease in prostate-specific antigen velocity of more than 50% compared to prior treatment; study was done in Sweden (3/9) |
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Adherex Technologies Inc. (AMEX:ADH) | ADH-1 | Cadherin antagonist; small peptide, tumor/vascular-targeting agent | Solid tumors | Phase Ib/II European trial showed tolerability, predictable pharmacokinetics and potential anti-tumor activity in five out of 30 patients (3/8) |
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Celgene Corp. (CELG) | Revlimid (FDA-approved) | Lenalidomide; derivative of Thalomid (thalidomide) | Multiple myeloma | Received a positive opinion from the EMEA's CMPH for use in combination with dexamethasone in patients who have received at least one prior therapy (3/23) |
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Cephalon Inc. (CEPH) | Fentora (FDA-approved) | Fentanyl effervescent buccal tablet | Breakthrough pain in cancer | Filed for European approval (3/27) |
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Genta Inc. (GNTA) | Genasense | Oblimersen sodium injection | Advanced melanoma | CMPH is expected to issue a negative opinion on the MAA (3/26) |
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Pain Therapeutics Inc. (PTIE) |
| A radio-labeled monoclonal antibody | Metastatic melanoma | Received approval in Israel to begin a Phase I trial (3/20) |
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Pharmexa A/S (Denmark; CSE:PHARMX) | GV1001 | Peptide vaccine that targets telomerase | Pancreatic cancer | Investigator began Phase III trial in the UK to evaluate if vaccine used with gemcitabine and capecitabine extends survival in 1,100 patients with inoperable disease (3/15) |
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Pharmion Corp. (PHRM) | Revlimid (FDA-approved) | Lenalidomide; derivative of Thalomid (thalidomide) | Multiple myeloma | European Medicines Agency accepted for review the marketing application (3/1) |
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CARDIOVASCULAR | ||||
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Encysive Pharmaceuticals Inc. (ENCY) | Thelin | Sitaxentan sodium; 100 mg tablets; a selective endothelin A receptor antagonist | Pulmonary arterial hypertension | Australian regulators approved Thelin (3/7) |
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Proteo Biotech AG (Germany; OTC BB:PTEO) | Elafin | Recombinant human protein; blocks elastase and proteinase 3 | Pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension | European Commission granted orphan drug status (3/29) |
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CENTRAL NERVOUS SYSTEM | ||||
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CeNeS Pharmaceuticals plc (UK; AIM:CEN) | M6G (M6G022) | Morphine-6-glucuronide peptide vector | Post-operative pain | Additional data from pivotal Phase III trial in more than 500 patients showed fewer anti-emetic drugs were required in M6G patients vs. morphine patients, and M6G had a long duration of analgesic action (3/7) |
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Medivation Inc. (AMEX:MDX) | Dimebon | Neuroprotectant agent that's been on the market in Russia since 1983 | Alzheimer's disease | Six-month data from 183-patient Phase II trial in Russia showed drug patients were significantly improved vs. placebo on all five efficacy endpoints (3/19) |
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Cytheris SA* (France) | --- | Recombinant interleukin-7 | HIV | Data from a Phase I/II trial in France and a Phase I trial in the U.S. demonstrated tolerability and an increase in CD4 T cells (3/5) |
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The Immune Response Corp. (OTC BB:IMRP) | NeuroVax | A T-cell-receptor peptide vaccine | Relapsing-remitting multiple sclerosis | The first patient was injected in a Phase II study being conducted in 200 patients in Central and Eastern Europe (3/8) |
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INFECTION | ||||
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CoGenesys Inc.* | Neugranin | A long-acting form of granulocyte-colony stimulating factor | To reduce infections associated with neutropenia | Started a Phase I/IIa study in Europe (3/27) |
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MediGene AG (Germany; FSE:MDG) | Polyphenon E (FDA-approved) | Ointment; product from green tea leaves designed to block virus binding to cells | Genital warts | MediGene filed for approval in Germany, Austria and Spain (3/28) |
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Oculus Innovative Sciences Inc. (OCLS) | Dermacyn Wound Care | Super-oxidized, water-based solution designed to treat a range of pathogens | Diabetic foot ulcers | Trial in 18 patients in Italy showed Dermacyn with antibiotics and standard therapy improved healing time and reduced reinfections and amputations, vs. 15 historical control patients (3/13) |
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MISCELLANEOUS | ||||
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AM-Pharma BV* (the Netherlands) | --- | Alkaline phosphatase | Acute renal failure | Data from 15-patient subgroup from a Phase IIa trial showed a statistically significant improvement in plasma creatinine clearance vs. placebo (3/12) |
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Cytos Biotechnology AG (Switzerland; SWX:CYTN) | CYT003-QbG10 | Virus-like particle packaged with an immunostimulatory sequence | Grass pollen allergy | Phase IIa trial in 40 patients with allergic rhinitis showed significant improvements in allergy symptoms vs. placebo (3/13) |
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Obecure Ltd.* (Israel) | OBE101 | Agent containing betahistine, a drug on the market in some countries outside the U.S. for treating vertigo | Weight management | Began Phase II trial in 78 subjects taking Zyprexa, an antipsychotic from Eli Lilly and Co.; the goal of the trial in Canada is prevention of weight gain (3/13) |
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Pharmaxis Ltd. (Australia; ASX:PXS) | Aridol | Mannitol formulation delivered via an inhalation device | Chronic obstructive pulmonary disease | Phase II trial in 79 patients in Australia did not demonstrate improved lung function, although improved hyper-responsive airways were seen in those with a positive Aridol challenge test (3/14) |
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Sucampo Pharmaceuticals Inc.* | Amitiza (FDA-approved) | Lubiprostone capsules; selective chloride channel activator | Chronic idiopathic constipation | Began Phase I trial in Japan to evaluate safety, tolerability and pharmacokinetics in subjects with renal or hepatic impairment (3/13) |
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Topigen Pharmaceuticals Inc.* | TPI ASM8 | Inhaled RNA-targeting drug | Asthma | Began a second, expanded, 14-day Phase II trial in 60 patients in Canada (3/8) |
Notes: | ||||
* Privately held. | ||||
CMPH = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AIM = Alternative Investment Market; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange. | ||||