Non-U.S. Clinical Trials, Regulatory Submissions, Recommendations And Approvals: August 2005
Company* | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE | ||||
Abbott | Humira (FDA-approved) | Adalimumab; fully human antibody designed to block TNF-alpha | Psoriatic arthritis and rheumatoid arthritis | The product was approved in Europe for treating PA and early RA (8/15) |
BioMS | MBP8298 | Synthetic peptide | Multiple sclerosis | Monitors in pivotal Phase II/III trial in the UK and Canada said the study should continue (8/18); trial was extended to Sweden (8/23) |
Cytochroma | CTA018 | Vitamin D analogue | Plaque psoriasis | Phase Ib trial in 28 patients showed the drug was safe and unlikely to produce adverse reactions (8/3) |
Isotechnika | ISA247 | Immunosuppressive agent | Plaque psoriasis | Blinded data from Canadian Phase III SPIRIT trial in 453 patients indicated positive safety and efficacy results (8/3) |
CANCER | ||||
Cel-Sci Corp. | Multikine | Mixture of human cytokines designed to stimulate an immune response | Advanced head and neck cancer | Started the Canadian arm of a Phase III trial expected to enroll 500 patients (8/23) |
MediGene AG | EndoTAG-1 | Carrier system designed to target paclitaxel to newly formed blood vessels | Advanced pancreatic cancer | Began Phase II trial in Europe to evaluate safety, tolerability and efficacy trends in combination with gemcitabine in 200 patients (8/24) |
Oxford | MetXia | Engineered retrovirus that delivers the P450 gene to tumor cells | Pancreatic cancer | First stage of Phase II trial in the UK demonstrated safety and tolerability in combination with cyclosphosphamide (8/1) |
Progen | PI-88 | Anti-angiogenesis drug also designed to inhibit tumor- romoting factors | Prostate cancer | Began Phase II trial in Australia to test drug with Taxotere in 82 patients with androgen-independent disease (8/9) |
Provectus | Provecta | Agent designed to be retained in tumor cells while leaving normal tissue unharmed | Stage III metastatic melanoma | Initial dose in Phase I trial in Australia was well tolerated; the higher dose now will be tested (8/17) |
TopoTarget | Savene | Dexrazoxane; inhibitor of topoisomerase II | Antidote to anthracyline extravasation | The company filed for approval of the product in Europe (8/18) |
YM | TheraCIM | Nimotuzumab; humanized anti-epidermal growth factor receptor monoclonal antibody | Non-small-cell lung cancer | Began Phase I/II trial in Canada to test drug with radiation vs. radiation alone in patients with Stage IIB and III disease (8/17) |
CARDIOVASCULAR | ||||
Encysive | Thelin | Sitaxsentan; small molecule designed to block endothelin | Pulmonary arterial hypertension | The EMEA accepted for review the marketing approval application, which was filed in July (8/17) |
Trigen | TGN 255 | Intravenous direct thrombin inhibitor | For use as an anticoagulant | Phase II trial in 28 patients under- going hemodialysis in Europe suggested the agent was effective with no increase in bleeding risk (8/9) |
United | Remodulin (FDA-approved) | Treprostinil sodium injection | Pulmonary hypertension | Approval in 22 additional coun- tries in Europe was gained upon completion of the Mutual Recog- nition Procedure for treating NYHA Class III primary disease (8/10) |
CENTRAL NERVOUS SYSTEM | ||||
Cephalon Inc. | Vigil (FDA-approved) | Provigil; modafinil | Shift-work sleep disorder | The product was approved in Germany for treating the disorder in in patients working night shifts (8/30) |
Neuren | Glypromate | Nanturally occurring peptide fragment found in brain with protective qualities | Neurocognitive disturbance | Began Phase II trial in Australia and New Zealand in 30 patients to test safety and pharmacokinetics (8/30) |
NeuroSearch | NS2330 | Agent designed to inhibit re- ptake of serotonin, noradrenaline and dopamine | Alzheimer's and Parkinson's diseases | Partner Boehringer Ingelheim GmbH decided not to move into Phase III trials after reviewing Phase II results in each indication (8/10) |
Vernalis plc | V1003 (IX-1003) | Intranasal formulation of buprenorphine | Pain | Began Phase II trial to test efficacy in 360 patients (8/22) |
WEX | Tetrodin | Tetrodotoxin; non-narcotic agent | Opioid withdrawal | Phase IIa trial in 14 methadone- maintained subjects showed drug failed to alleviate the withdrawal symptoms (8/18) |
YM BioSciences | AeroLEF | Aerosolized liposome- encapsulated fentanyl | Pain | YM subsidiary Delex Therapeutics Inc. is starting a Phase IIb trial in Canada in 120 post-surgical patients following orthopedic surgeries (8/30) |
INFECTION | ||||
Acambis plc | ChimeriVax-JE | Vaccine against Japanese encephalitis | Japanese encephalitis | Succesfully completed bridging studies following manufacturing scale-up; also reported positive data from Phase II trials (8/23) |
Immtech | DB289 | Oral, dicationic antiviral agent | African | Began pivotal Phase III trial in the Republic of the Congo that will compare drug to pentamididine in 250 patients (8/25) |
Migenix Inc. | MX-3253 | Celgosivir; inhibitor of the mammalian cell enzyme alpha-glucosidase I | Hepatitis C | Began Phase IIb combination trial in up to 20 patients with peginterferon alfa-2b and ribavirin (8/11) |
MISCELLANEOUS | ||||
Allergy | -- | Vaccine that incorporates MPL, a TLR-4 agonist | Ragweed allergy | Began pivotal Phase II trial in Canada that will evaluate efficacy vs. placebo (8/30) |
Orthogen AG* | Orthokine | IL-1Ra protein obtained | Osteoarthritis | Trial in Germany in 400 patients showed superiority to hyaluronic acid therapy and placebo (8/10) |
Pharmaxis Ltd. | Bronchitol | Mannitol formulation delivered via an inhalation device | Cystic fibrosis | Phase II trial in 49 patients in Australia and New Zealand showed statistically significantly improved lung function vs. placebo (8/31) |
Protherics plc | Voraxaze | Product containing the recombinant enzyme glucarpidase | Toxicity from methotrexate | The company submitted an MAA seeking approval of the product in Europe (7/28)@ |
Threshold | TH-070 | lonidamine; an indazole- 3-carboxylic acid | Benign prostatic hyperplasia | Began Phase III trial in Europe to measure efficacy vs. placebo in 480 patients (8/8) |
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Notes: | ||||
* Privately held. | ||||
MAA = Marketing authorization application; EMEA = European Medicines Agency. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
@ = New occurred in July but was not included in previous chart. | ||||
AIM = Alternative Investment Market; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||