Company* |
Product | Description | Indication |
Status (Date) |
| | ||||
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) |
| | ||||
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. | ||||
