Company* |
Product | Description |
Indication | Status (Date) |
| ||||
CANCER | ||||
Ardana |
Teverelix LA |
Long-acting gonadotrophin |
Prostate cancer |
13 of 14 patients in a Phase II trial showed reduced levels of testosterone equivalent to those of castrated men (2/17) |
Australian |
RP101 |
Antiviral drug marketed in Europe that down- regulates the STAT3 and APEX genes |
Late-stage pancreatic cancer |
Phase I/II trial in 13 patients showed a doubling of survival time with gemcitabin and cisplatin vs. those agents alone (2/9) |
ChemGenex |
Quinamed |
Naphthalimide analogue; topoisomerase II inhibitor |
Advanced cancers |
Presented updated Phase I/II data showing positive benefits when combined with standard cancer drugs (2/8) |
Cougar |
CB7630 |
Abiraterone acetate; targeted oral therapy |
Prostate cancer |
Published results of Phase I trial in the UK showed treatment suppressed testosterone levels (2/21) |
GPC Biotech |
1D09C3 |
Anti-major histocom- patibility complex Class II monoclonal antibody |
B-cell lymphomas |
Began Phase I study in Switzerland, Germany and Italy in patients with relapsed or refractory disease (2/1) |
Maxim |
Ceplene |
Histamine dihydrochloride in combination with interleukin-2 |
Metastatic renal- cell carcinoma |
Phase II trial in Denmark showed trend toward improved survival but not tumor response vs. IL-2 alone; Phase II trial in the UK showed no difference in either endpoint (2/8) |
Oncolytics |
Reolysin |
Formulation of the human reovirus |
Advanced cancers |
Got OK to start Phase I trial in the UK to evaluate feasibility, safety and antitumor activity in combination with radiation (2/18) |
Oncoscience |
TheraCIM |
Humanized anti-epidermal growth factor receptor monoclonal antibody |
Brain cancer in children |
Phase II trial showed a 35.3% response rate in 17 evaluable children who had failed other treatments (2/28) |
PharmaMar |
Aplidin |
Antitumor agent derived from the marine tunicate Aplidium albicans |
Bladder cancer |
Began Phase II trial in Europe to evaluate tumor response in 42 patients with advanced disease (2/17) |
pSivida Ltd. |
BrachySil |
Micron-sized particle in which the isotope 32- phosphorus is immobilized |
Liver cancer |
Data from four patients in Phase IIa trial showed average tumor regression by volume of 80% (2/14) |
Transgene |
MVA-Muc1-IL2 |
Recombinant MVA virus containing sequences encoding for the human MUC1 antigen and the cytokine IL-2 |
Non-small-cell lung cancer |
13 of 35 patients in a Phase II trial experienced a partial response and 11 had disease stabilization for more than 12 weeks; the drug was used with cisplatin and vinorelbine (2/23) |
Viragen Inc. |
Multiferon |
Multisubtype, human alpha interferon derived from white blood cells |
Malignant melanoma |
Filed for approval in Sweden to expand labeling to include firstline adjuvant treatment, following dacarbazine after surgical removal of tumors (2/4) |
Xenova |
TransMID |
Modified diphtheria toxin conjugated to transferrin |
Glioma |
Partner Sosei Co. Ltd. was granted orphan drug status in that indication in Japan (2/14) |
CARDIOVASCULAR | ||||
Cytos |
CYT006-AngQb |
Vaccine designed to produce an anti-angiotensin II antibody response |
Hypertension |
Pilot trial in 16 volunteers showed the drug was safe, well tolerated and immunogenic (2/14) |
D-Pharm Ltd.* |
DP-b99 |
Neuroprotective agent based on selective modution of calcium, zinc, copper and iron homeostasis |
Acute stroke |
Began confirmatory Phase IIb trial in 150 patients in Europe and Israel (2/8) |
Portola |
-- |
Oral Factor Xa inhibitor |
Venous thrombosis |
Began a Phase Ib trial in the UK; the drug is being developed as an anticoagulant (2/7) |
CENTRAL NERVOUS SYSTEM | ||||
Axonyx |
Phenserine |
Inhibitor of acetylcholin- |
Alzheimer's disease |
Phase III trial in 384 patients in Europe showed positive trends, but failed to demonstrate statistical significance following 26 weeks of treatment (2/7) |
Orexo AB* |
OX 22 |
Sublingual formulation of an undisclosed agent |
Insomnia |
Company said it completed an efficacy trial with positive results (2/28) |
INFECTION | ||||
Anadys |
ANA975 |
Oral prodrug of Anadys' isatoribine, an agonist of Toll-like receptor 7 |
Hepatitis C |
Began Phase I trial in the UK to test safety, tolerability and pharmacokinetics in 18 healthy volunteers (2/2) |
Bioenvision |
Virostat |
Antiviral agent |
Hepatitis C |
Began Phase II trial in Europe and Egypt to assess viral load reduction and quality of life in patients with chronic disease (2/16) |
Cangene Corp. |
WinRho SDF (FDA-approved) |
Antibody to certain types of red blood cells |
Dengue hemorrhagic fever |
Trial in the Philippines met its primary endpoint of increasing platelet counts by 20,000 at 48 hours after dosing (2/15) |
Gilead |
Truvada (FDA-approved) |
Fixed-dose combination of the company's approved Viread and Emtriva drugs |
HIV |
The European Commission approved the drug in all 25 member states of the European Union for use in combination regimens (2/23) |
Millenia Hope |
MMH Malarex |
Antimalaria agent |
Malaria |
Began extended trial in the Republic of Central Africa testing the drug in 360 pediatric patients (2/22) |
Targeted Genetics Corp. |
tgAAC09 |
Gene therapy using AAV vector to elicit immune system responses |
HIV |
Phase I trial in 30 volunteers in Belgium and Germany showed no safety concerns and that the vaccine was well tolerated (2/22) |
Targeted |
tgAAC09 |
Gene therapy using AAV vector to elicit immune system responses |
HIV |
International partnership began Phase I trial in India to test safety in 30 volunteers (2/7) |
MISCELLANEOUS | ||||
Arexis AB* |
BSSL |
Human enzyme-replacement therapy; bile salt-stimulated lipase |
Fat malabsorption in cystic fibrosis patients |
The European Commission granted orphan status to the drug in that indication (2/9) |
Biolipox AB* |
NLA Nasal Spray (NCX 1510) |
Antihistamine agent delivered via nasal spray |
Allergic rhinitis |
Trial in 12 volunteers showed the product had an onset of effect within five to 10 minutes (2/22) |
IDEA AG* |
IDEA-070 |
Topical dermatological agent |
Inflammatory skin diseases |
Began Phase II study to examine safety and efficacy in various conditions in 225 patients in Germany (2/10) |
Manhattan |
Oleoyl estrone |
Oral therapeutic for weight loss |
Obesity |
Began Phase I trial in Switzerland to evaluate safety and tolerability in 36 obese volunteers (2/3) |
Pharmaxis Inc. |
Bronchitol |
Mannitol formulation delivered via an inhalation device |
Cystic fibrosis |
Began a Phase II trial in the UK that will compare the drug to Pulmozyme in 42 patients (2/9) |
Topigen |
ASM8 |
Inhaled dual antisense drug designed to block two pathways of the inflammation response |
Asthma |
Began Phase I trial in Canada to evaluate safety (2/17) |
Vivus Inc. |
Testosterone MDTS |
Transdermal testosterone spray |
Hypoactive sexual desire disorder |
Phase II trial with 261 premenopausal women in Australia demonstrated a statistically significant increase in satisfactory sexual events at week 16 for the second highest dose vs. placebo (2/9) |
| ||||
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. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; LSE = London Stock Exchange; NM = Nouveau Marche; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. |
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