Company* |
Product | Description | Indication |
Status |
AUTOIMMUNE | ||||
Serono SA |
Raptiva (FDA-approved) |
Efalizumab; humanized antibody designed to block T cells implicated in psoriasis |
Psoriasis |
73% of patients who remained on therapy for 36 months achieved a 75% or greater improvement of PASI 75; also, the CLEAR trial demonstrated that high-need patients benefit from treatment (5/23) |
CANCER | ||||
Adherex |
Exherin (ADH-1) |
Cadherin antagonist; small peptide, tumor/ vascular-targeting agent of repeated doses (5/11) |
Various tumor types |
Began Phase II trial in up to 60 patients in Canada to evaluate the antitumor activity and tolerability |
Alizyme plc |
ATL-104 |
Recombinant plant protein designed to stimulate growth of cells that line the gastrointestinal tract |
Mucositis in cancer patients |
Stage one of a Phase IIa trial demonstrated safety in 27 patients (5/26) |
Antisoma plc |
AS1404 |
Vascular-targeting agent designed to disrupt tumor blood vessels |
Cancer |
Phase I trial in New Zealand demonstrated tolerability and effects on tumor blood vessels (ASCO) |
Antisoma plc |
AS1405 (formerly AngioMab) |
Radiolabeled antibody that binds to a protein found around new tumor blood vessels |
Brain cancer |
The company dropped the drug and suspended trials (5/5) |
Astex |
AT7519 |
Cell-cycle inhibitor |
Refractory solid tumors |
The company is starting a Phase I trial in patients (5/23) |
Ardana plc |
Teverelix LA |
Gonadotropin-releasing hormone antagonist |
Advanced prostate cancer |
Phase II trial in 14 patients showed drug can attain and maintain suppression of testosterone to castration levels (5/12) |
Biomira Inc. |
BLP25 |
Therapeutic vaccine encapsulating a sequence of the MUC1 cancer mucin in a liposomal delivery system |
Non-small-cell lung cancer (Stage IIIb) |
Phase IIb data showed the median survival of best supportive care patients was 13.3 months; at two years, median survival had not been reached in vaccine patients (ASCO) |
Cyclacel Group |
Seliciclib (CYC202) |
Small-molecule inhibitor of multiple CDK cell- cycle targets |
Non-small-cell lung cancer |
Initial data from Phase IIa trial in Europe showed the feasibility of drug with gemcitabine and cisplatin, and showed activity (ASCO) |
Immuno- |
Uvidem |
Vaccine consisting of mature dendritic cells loaded with lysates of tumor cell lines |
Melanoma |
Phase II trial in 60 Stage IV patients in France and Australia demonstrated tolerability and immune responses (ASCO) |
Lorus |
Virulizin |
Immunotherapy agent |
Pancreatic cancer | Phase III data showed how Virulizin induced production of IL-17E to enhance antitumor activity (ASCO) |
Lorus |
GTI-2040 |
Antisense oligonucleotide complementary to the R2 component of ribonucleo- tide reductase | Non-small-cell lung cancer |
Clinical data showed GTI-2040 in combination with docetaxel had no dose-limiting toxicities (ASCO) |
Meditech |
HyDox and HyFive |
Products containing hyaluronic acid with doxorubicin and 5-FU, respectively |
Cancers |
Phase I trials demonstrated safety of the drugs; antitumor responses were noted in several patients (5/19) |
MethylGene Inc. |
MGCD0103 |
Isotypic-selective small- molecule inhibitor of histone deacetylase |
Non-Hodgkin's lymphoma and advanced solid tumors |
Phase I data demonstrated safety, tolerability and pharmacokinetics (ASCO) |
Novagali |
-- |
Oral formulation of paclitaxel |
Advanced cancers |
Began Phase I trial in the Netherlands to assess tolerability and pharmacokinetics (5/31) |
Onyvax |
Onyvax-P |
Cell vaccine; an immunotherapy |
Metastatic, hormone- resistant prostate cancer |
Second cohort of 20 patients in Phase II trial demonstrated benefits on progression-free survival and PSA velocity (ASCO) |
Oxford |
TroVax |
Vaccine that delivers an antigen (5T4) using a pox- virus vector |
Colorectal cancer |
Phase II data show that maximum antibody levels targeted against the 5T4 tumor antigen are significantly higher than in the Phase I/II trial (ASCO) |
PharmaMar SA |
Yondelis |
Trabectedin; ET-743; derived from the sea squirt Ecteinascidia turbinata |
Advanced prostate cancer |
Clinical data suggest the compound is effective in reducing PSA and alleviating pain in about 12% of men with advanced prostate cancer (ASCO) |
PharmaMar SA |
Kahalalide F |
Peptides isolated from the Hawaiian mollusk, Elysia rufescens |
Solid tumors |
Phase I data showed a complete response in a patient with melanoma, and stable disease lasting more than three months in lung, colon and unknown-origin adenocarcinoma patients (ASCO) |
Pharmexa A/S(Denmark; CSE:PHARMX) |
GV1001 |
Peptide vaccine |
Non-small-cell lung cancer |
Phase I/II data showed no serious side effects and an immune response in 13 out of 24 patients completing four weeks of treatment (ASCO) |
Progen |
PI-88 |
Anti-angiogenesis drug also designed to inhibit tumor-promoting factors |
Melanoma |
Pilot Phase II trial demonstrated acceptable safety; of 37 patients, one had a partial response and 10 had stable disease (ASCO) |
Santaris |
SPC2996 |
LNA-based RNA antagonist designed to reduce levels of the Bcl-2 protein |
Chronic lymphocytic leukemia |
Began Phase I/II trial in Europe in patients who don't respond to chemotherapy (5/19) |
Viventia Biotech |
Proxinium |
Antibody fragment conjugated with a cancer- killing payload |
Refractory head and neck cancer |
Clinical data showed the compound has a good safety profile and can produce encouraging efficacy results (ASCO) |
Wilex |
Rencarex (WX-G250) |
Chimeric monoclonal IgG1 antibody that binds to the MN cell-surface antigen |
Metastatic renal-cell cancer |
Patients who responded to treatment in a Phase II trial showed a survival benefit following extended treatment (ASCO) |
YM |
TheraCIM h-R3 |
Humanized anti-epidermal growth factor receptor monoclonal antibody |
High-grade malignant glioma |
21 of 24 patients in a Phase I/II trial in Cuba achieved disease stabilization or an objective response (ASCO) |
CARDIOVASCULAR | ||||
Myogen Inc. |
Ambrisentan |
Type-A selective endothelin receptor antagonist |
Pulmonary arterial hypertension |
The product was granted orphan designation in Europe for PAH and chronic thromboembolic pulmonary hypertension (5/2) |
Pharming |
rhC1INH |
Recombinant human C1 inhibitor |
Hereditary angioedema |
Phase II/III trials in Europe demonstrated rapid time to beginning of relief and time to resolution of HAE attacks(5/2) |
CENTRAL NERVOUS SYSTEM | ||||
Corcept |
Corlux (mifepristone) |
Oral GR-II antagonist with potential mitigating effects on cortisol |
Psychotic major depression |
Began third Phase III trial, a study in Europe (Corcept 09) to evaluate the safety and efficacy in up to 280 patients (5/4) |
Cortex |
CX717 |
Ampakine analogue |
Sleep deprivation |
Trial in the UK in 16 people showed increased wakefulness and improved performance vs. placebo (5/2) |
Cytos |
CAD106 |
Immunotherapeutic designed to induce antibodies against the beta-amyloid protein |
Alzheimer's disease |
Partner Novartis Pharma AG is starting a Phase I trial in Sweden that will assess safety, tolerability and antibody responses in 60 patients (5/18) |
Cytos |
CYT002-NicQb |
Therapeutic vaccine that induces nicotine-specific antibodies that bind nicotine |
Smoking cessation |
Phase II trial in 341 smokers in Switzerland showed a clear correlation between antibody levels and abstinence rates (ASCO) |
Enkam Pharmaceuticals |
FGLL |
Synthetic peptide that mimics the neural cell-adhesion molecule |
Alzheimer's disease |
Phase I trial in 24 healthy volunteers demonstrated safety and tolerability (5/18) |
Myriad |
Flurizan |
Selective amyloid beta 42 lowering agent |
Alzheimer's disease |
Phase II trial in 189 patients in the UK and Canada failed to demonstrate statistical significance, but positive trends were seen (5/2) |
DIABETES | ||||
Generex |
Orallyn |
Oral insulin spray formulation |
Type I and II diabetes |
The product was approved in Ecuador; PharmaBrand SA will market the product there (5/3) |
Actelion Ltd. |
Palosuran |
Urotensin-II receptor antagonist |
Diabetic nephropathy |
Efficacy data from proof-of-concept study did not support initiation of a full clinical development program (5/23) |
INFECTION | ||||
BioAlliance |
Miconazole Lauriad |
Oral, bioadhesive buccal tablet containing the antifungal miconazole |
Oropharyngeal candidiasis |
Phase III trial in France and North Africa demonstrated efficacy in head and neck cancer patients with 10 times less drug than the miconazole oral gel comparator (ASCO) |
BioInvent |
BI-201 |
Human antibody that binds to the TAT protein |
HIV |
Starting a Phase I/II trial in the UK to evaluate safety, tolerability and pharmacokinetics in 36 previously untreated patients (5/18) |
Immtech |
DB289 |
Oral, dicationic antiviral agent |
Malaria |
Began Phase IIb trial in 120 patients in Thailand that will test the drug alone and with artesunate (5/11) |
Nabi Bio-pharmaceuticals |
StaphVAX |
Staphylococcus aureus polysaccharide conjugate vaccine |
To prevent S. aureus infections |
Began Phase II trial in the UK to evaluate safety and antibody levels in 200 patients undergoing orthopedic surgery with a prosthetic device (5/17) |
MISCELLANEOUS | ||||
Aastrom |
Tissue Repair Cells |
Autologous bone marrow-derived adult stem and progenitor cells |
Severe long bone non- union fractures |
Feasibility trial in Spain showed clinical and functional healing in all six patients treated (5/17) |
Acologix Inc.* |
AC-100 (Dentonin) |
Synthetic peptide derived from a protein produced by bone and dental cells |
For use in dental procedures |
Began a Phase II periodontal trial in Serbia-Montenegro (5/25) |
Allergy |
-- |
Ragweed allergy vaccine |
Ragweed allergy |
Began a Phase II trial in Canada to assess safety and efficacy in 240 patients (5/10) |
Ardana plc |
Teverelix LA |
Gonadotropin-releasing hormone antagonist |
Benign prostatic hyperplasia |
Phase II trial in 81 patients showed a statistically significant decrease in prostatic symptoms (5/26) |
Cytos |
CYT009-GhrQb |
Therapeutic vaccine designed to produce a specific anti-ghrelin response |
Obesity |
Began a Phase I/II trial in 112 obese subjects to evaluate safety, tolerability and exploratory efficacy (5/11) |
DeCode |
-- |
Compound that targets a gene implicated in development of asthma |
Asthma |
Began a Phase II trial in 160 patients with the at-risk variants of the gene (5/18) |
Eyetech |
Macugen (FDA-approved) |
Pegaptanib sodium injection; pegylated anti-VEGF aptamer |
Wet age-related macular degeneration |
The product was approved in Canada for treating subfoveal choroidal neovascularization secondary to neovascular AMD (5/5) |
Insense Ltd.* |
Oxyzyme |
System designed to clean a wound, produce oxygen and release small amounts of iodine |
Chronic wounds |
Data from clinical trials showed improvement and healing in a number of wounds in four weeks (5/23) |
Insmed Inc. |
SomatoKine |
Composition of insulin- |
Growth hormone- insensitivity syndrome |
Pivotal Phase III trial in 29 patients met its primary endpoint of change in height velocity after six months (5/31) |
InterMune |
Pirfenidone |
Small molecule believed to inhibit collagen synthesis, down-regulate profibrotic cytokines and decrease fibroblast proliferation |
Idiopathic pulmonary fibrosis |
12-month Phase II trial in 107 patients was stopped at nine months after interim analysis suggested favorable effects of pirfenidone on acute exacerbations and other efficacy parameters; Shionogi & Co. Ltd. ran the trial (5/2) |
Karo Bio |
KB2115 |
Compound that stimulates the thyroid hormone receptor |
Obesity and related conditions |
Got approval for clinical studies of the product; details were not disclosed (5/11) |
Manhattan |
Oleoylestrone |
Oral therapeutic for weight loss |
Obesity |
Completed Phase Ia trial in Switzerland and began Phase Ib trial there to evaluate safety and tolerability of defined doses (5/4) |
NexMed Inc. |
Femprox |
Alprostadil cream |
Female sexual arousal disorder |
400-patient trial in China demonstrated statistically significant arousal success rate vs. placebo (5/23) |
Threshold |
TH-070 |
lonidamine; an indazole-3-carboxylic acid |
Benign prostatic hyperplasia |
Follow-up data from Phase II trial in Italy showed BPH symptoms remained significantly improved six months following treatment (5/19) |
| ||||
Notes: | ||||
* Privately held. | ||||
ASCO = Data were presented at the American Society of Clinical Oncology meeting May 14-17. | ||||
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; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. |