Company* |
Product |
Description | Indication |
Status |
| | ||||
AUTOIMMUNE | ||||
Active Biotech |
57-57 |
Product derived from |
Lupus |
Phase I trial in 30 volunteers in |
Advitech Inc. |
XP-828L |
Oral growth factor |
Psoriasis |
84-patient trial demonstrated efficacy vs. placebo on a physician's global assessment scale, the primary endpoint (7/5) |
York Pharma |
YP003 |
Agent designed to inhibit an enzyme that regulates cellular proliferation |
Psoriasis |
Began Phase II trial in Australia to compare drug to calcipotriol or placebo (7/1) |
CANCER | ||||
Amgen Inc. |
Kepivance (FDA- approved) |
Palifermin; recombinant human keratinocyte growth factor |
Oral mucositis in cancer patients |
Regulatory committee in Europe recommended approval of the product (7/28) |
AVAX |
M-Vax |
Autologous, hapten-modified melanoma vaccine |
Metastatic peritoneal cancer |
Began a trial in France that will evaluate safety and vaccine activity (7/13) |
GammaCan |
GCAN 101 |
Therapy based on intravenous immuno-globulin |
Cancers |
Began Phase II trial in up to 30 patients with various cancers (7/26) |
KuDOS |
-- |
Oral polyADP ribose polymerase inhibitor |
Breast and ovarian cancers |
Began Phase I study in the UK to evaluate safety and tolerability in patients (7/25) |
Oncolytics |
Reolysin |
Formulation of the human reovirus |
Advanced solid tumors |
Began Phase I trial in the UK to test safety, tolerability, dosing and actvitity with radiation therapy in up to 45 patients (7/26) |
OSI |
Tarceva |
Erlotinib HCl; small-molecule HER1/EGFR inhibitor |
Advanced non-small-cell lung cancer |
The product was approved in Canada for treating NSCLC following failure of first- or second- line chemotherapy (7/13) |
Provectus |
PV-10 |
Agent designed to be retained in tumor cells while leaving normal tissue unharmed |
Stage III metastatic melanoma |
Began Phase I trial to evaluate safety and preliminary efficacy in 20 subjects in Australia (7/21) |
Wilex AG* |
WX-671 |
Oral, second-generation serine protease inhibitor targeting the uPA system |
Solid tumors |
Phase I trial in 16 healthy volunteers demonstrated safety, tolerability and oral bioavailablity (7/27) |
CARDIOVASCULAR | ||||
Encysive |
Thelin |
Sitaxsentan; small molecule designed to block endothelin |
Pulmonary arterial hypertension |
Completed submission of MAA with the EMEA, seeking approval of the product in Europe (7/28) |
CENTRAL NERVOUS SYSTEM | ||||
Durect Corp. |
SABER-Bupivacaine |
Sustained-release formulation of bupivacaine delivered by SABER system |
Post-operative pain |
Began third and final cohort of Phase II trial, in 60 hernia patients in Australia (7/11) |
Intrac Inc. |
Dyloject |
The analgesic diclofenac sodium for injection |
Pain |
Pivotal European Phase II/III trial met its primary endpoint of superior pain relief over 4 hours vs. placebo and therapeutic non-inferiority to Voltarol (7/12) |
DIABETES | ||||
Generex |
Oral-lyn |
Oral insulin buccal spray formulation |
Type I diabetes |
Phase I trial demonstrated comparable blood glucose levels to injectable regular insulin (7/6) |
INFECTION | ||||
Avant |
CholeraGarde |
Vaccine based on the Peru-15 attenuated strain of cholera |
Cholera |
Phase II trial in infants and children in India showed a single dose to be well tolerated and highly immunogenic (7/27) |
Paratek |
PTK 0796 |
Broad-spectrum antibiotic from the aminomethylcycline class |
Infections |
Began Phase I trial in the UK to evaluate safety and tolerability in healthy subjects (7/28) |
The Immune |
Remune |
Immune-based therapy comprising a whole-killed virus and an adjuvant |
HIV |
Phase II data from trials in Spain showed drug delayed virologic failure during treatment interruption; and that treatment induced allo-specific responses (7/27) |
The Immune |
IR103 |
Combination of HIV-1 Immunogen and Amplivax, an immunostimulatory oligonucleotide adjuvant |
HIV |
Preliminary data from trial indicates the product is safe, induces HIV-specific immune responses and enhances IFN-gamma and RANTES mRNA (7/26) |
Sinovac |
Anflu |
Influenza vaccine |
Influenza |
Chinese regulators issued a production license, which authorizes Sinovac to begin vaccine production (7/27) |
York Pharma |
Abasol (abafungin) |
Broad-spectrum anti- fungal and antibacterial agent |
Dermatomycoses |
Filed for approval in the UK as the first step for seeking approval throughout Europe (7/29) |
MISCELLANEOUS | ||||
BioXell SpA* |
BXL628 |
Inhibitor of growth factor phosphorylation and bcl-2 |
Benign prostatic hyperplasia |
Began Phase IIb trial in Italy that will evalaute the effect on prostate volume in more than 500 patients (7/7) |
Corgentech |
NF-kB Decoy |
Inhibitor of the NF-kB transcription factor |
Atopic dermatitis (eczema) |
Began Phase I/II trial in Switzerland and Australia to evaluate safety and tolerability in 120 patients (7/21) |
Diurnal Ltd.* |
-- |
Modified-release hydrocortisone tablet |
Congenital adrenal hyperplasia |
The product was granted orphan designation in Europe in that indication (7/26) |
NicOx SA |
HCT 1026 |
Nitric oxide-donating derivative of flurbiprofen |
Osteopenia (low bone density) |
Pilot Phase II trial showed a significant reduction in bone resorption markers (7/11) |
Novogen Ltd. |
Glucoprime |
Gel formulation of a carbohydrate extracted from yeast cell walls |
Venous stasis ulcers |
Phase II trial in 60 patients in Australia showed the drug promoted wound healing significantly faster than placebo (7/12) |
PTC |
PTC124 |
Oral agent that targets nonsense mutations |
Duchenne's muscular dystrophy and cystic fibrosis |
The EMEA granted orphan designation to the product in Europe in both indications (7/7) |
7TM Pharma |
TM30338 |
Peptide that targets two types of Y receptors |
Obesity |
Began Phase I/II trials of the product (7/7) |
| | ||||
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. | ||||
AIM = Alternative Investment Market; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; TSE = Toronto Stock Exchange. | ||||
