Company* |
Product | Description |
Indication | Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Biogen Idec |
BG-12 |
Oral fumarate derivative with an immunomodulatory mechanism of action |
Psoriasis |
Phase III trial in 175 patients demonstrated a statistically significant improvement in median psoriasis severity score after 16 weeks (4/7) |
Biogen Idec |
BG-12 |
Oral fumarate derivative with in immunomodulatory mechanism of action |
Multiple sclerosis |
Began a Phase II trial in 250 patients in Europe with relapsing-remitting MS that will assess brain lesion activity at six months (4/7) |
Genelabs |
Prestara |
Prasterone; synthetic equivalent of dehydro- epiandrosterone |
Lupus |
Phase III trial conducted by Genelabs' licensee in Taiwan failed to demonstrate a statistically significant benefit vs. placebo (4/6) |
Isotechnika |
ISA247 |
Immunosuppressive agent |
Plaque psoriasis |
Data from 200 patients in Canadian Phase III SPIRIT trial showed PASI scores were reduced (4/25) |
CANCER | ||||
Abiogen Pharma (Italy) |
ABIO 05/01 |
Cytotoxic cell line derived from the cells of a child with a rare form of T-cell leukemia |
Peritoneal carcinosis |
Began Phase I/II trial in Italy in 18 * patients with advanced tumors to evaluate safety and dosing (4/18) |
Adventrx |
CoFactor |
Form of folic acid designed to enhance the antitumor effects of 5-FU |
Metastatic colorectal cancer |
Began a Phase II trial in Europe to evaluate safety and efficacy with 5-fluorouracil in 300 patients (4/15) |
Antisense |
AP 12009 |
TGF-beta2 antisense inhibitor |
Cancers |
Began Phase I/II trial in Germany in patients with pancreatic carcinoma and malignant melanoma (4/29) |
Argos |
-- |
RNA-loaded dendritic- cell vaccine made for a patient's own tumor RNA and immune cells |
Stage IV melanoma |
An investigator-sponsored trial of the product began in Germany (4/6) |
Ariad |
AP23573 |
Small molecule designed to inhibit cell-signaling protein mTOR |
Various cancers |
Began two Phase Ib trials in Europe to evaluate the drug and dosing with two standard cancer agents in up to 110 patients (4/20) |
Biomira Inc. |
BLP25 |
Therapeutic vaccine encapsulating a sequence of the MUC1 cancer mucin in a liposomal delivery system |
Non-small-cell lung cancer |
Began trial in Canada in 20 patients to evaluate the safety of the formulation to be used in the upcoming Phase III study (4/20) |
BioVex Ltd.* |
Immuno |
Vaccine using herpes simplex virus to deliver melanoma-associated antigens to dendritic cells |
Malignant melanoma |
Began Phase I/II trial in the UK and Canada to evaluate safety and biological activity in 50 patients (4/27) |
BioVex Ltd.* |
OncoVEX |
Oncolytic virus that delivers the gene for GM-CSF |
Solid tumors |
Data from Phase I/II trial showed the agent was well tolerated and produced biological effects (4/19) |
CureTech Ltd.* |
CT-011 |
Humanized monoclonal antibody directed against a B7 family- associated protein |
Advanced hematological malignancies |
Phase I trial in 17 patients in Israel demonstrated safety and tolerability; clinical responses were seen in five patients (4/11) |
Cytopia Ltd.* |
CYT997 |
Oral agent believed to both directly kill cancer cells and starve the cancer of its blood supply |
Solid tumors |
Began a Phase I trial in Australia to evaluate safety, tolerability, dosing and activity in up to 30 patients (4/27) |
Inovio |
MedPulser System |
Electroporation-mediated method for delivering DNA-based therapies |
Recurrent prostate cancer |
Began Phase I/II trial in the UK to test immune responses from a DNA vaccine developed at the University of Southampton (4/4) |
MGI |
Aloxi (FDA-approved) |
Palonosetron hydrochloride injection; a 5-HT3 receptor antagonist |
Nausea and vomiting in chemotherapy patients |
Partner Helsinn Healthcare SA gained approval of the product in the European Union (4/4) |
Micromet AG* |
MT201 |
Adecatumumab; fully human antibody targeting the epithelial adhesion molecule Ep-CAM |
Relapsed breast cancer |
Began a Phase I trial in Germany and Austria in 12 patients to evaluate safety and tolerability (4/27) |
Millennium |
Velcade (FDA-approved) |
Bortezomib; proteasome inhibitor |
Multiple myeloma |
Partner Ortho Biotech gained approval of the drug in Europe for use in second-line treatment (4/28) |
Onyvax Ltd.* |
Onyvax-105 (105AD7) |
Anticancer immunotherapy |
Osteosarcoma |
Phase I/II trial in 31 pediatric and young adult patients in the UK showed the feasibility of the treatment with chemotherapy (4/19) |
Spectrum |
EOquin |
Synthetic prodrug activated by certain enzymes prevalent in hypoxic cancer cells |
Superficial bladder cancer |
Updated Phase I/II trial data from 12 patients in the UK suggested the drug was safe and effective (4/19) |
Spectrum |
SPI-153 (D-63153) |
Fourth-generation luteinizing hormone-releasing hormone |
Hormone- dependent prostate cancer |
Began a Phase II trial in Europe to evaluate the effects on hormonal levels, and antitumor effects (4/11) |
Viragen Inc. |
Multiferon |
Multisubtype, natural human alpha interferon |
Various diseases |
Drug was approved in the Philippines for the second-line treatment of any diseases in which recombinant interferon therapy failed (4/25) |
CARDIOVASCULAR | ||||
Protein |
Ularitide |
Atrial natriuretic peptide |
Decompensated congestive heart failure |
Phase II SIRIUS trial in 221 patients in Europe showed reduced pulmonary capillary wedge pressure and improved dyspnea scores (4/18) |
CENTRAL NERVOUS SYSTEM | ||||
CeNeS |
M6G |
Morphine-6- |
Post-operative pain |
Published data from trial showed analgesic potency similar to morphine with fewer side effects (4/11) |
Migenix Inc. |
MX-4509 |
Cytoprotective agent |
Alzheimer's disease |
Began Phase I/II trial in Canada to assess safety, tolerability and effects on oxidative stress markers in 14 patients (4/28) |
Neuro3d* |
Ocaperidone |
Atypical antipsychotic |
Schizophrenia |
Phase II trials showed effects that were significantly better than placebo and comparable to an approved atypical antipsychotic agent, with a good side effect profile (4/12) |
Prana |
PBT-1 (clioquinol) |
Small molecule that binds metal ions; designed to remove zinc bound to amyloid-beta |
Alzheimer's disease |
Company will not proceed with Phase II/III trial in the UK due to impurities that occur in the manufacturing process; any further work is being evaluated (4/11) |
Synt:em* |
Syn 1001 |
Morphine-6-glucoronide linked to a small Pep:trans peptide vector |
Pain |
Proof-of-concept study in human volunteers showed evidence of penetration into the brain (4/13) |
DIABETES | ||||
Innodia Inc.* |
ID 1101 |
Agent designed to increase insulin secretion by the pancreas and decrease peripheral insulin resistance |
Type II diabetes |
Began a Phase Ib trial in Canada in healthy volunteers to assess safety, tolerability and pharmacokinetics; Phase Ia trial showed safety and tolerability (4/6) |
INFECTION | ||||
AEterna |
Impavido |
Oral miltefosine, an alkylphospholipid agent |
Leishmaniasis |
Presented positive data from various studies and various forms of the disease (4/14) |
Anadys |
ANA380 (LB80380) |
Oral prodrug of the nucleotide analogue ANA317 (LB80317) |
Hepatitis B |
12-week data from ongoing Phase II trial showed viral load reductions of 99.9% in lamivudine- resistant patients receiving 90- mg doses (4/18) |
Bioniche Life |
Cystistat |
Sodium hyaluronate product |
Urinary tract infections |
Two pilot trials each showed reduced incidence of UTIs; the product is approved in Canada and Europe (4/18) |
GenoMed Inc. |
-- |
Broad-spectrum antiviral agent |
Marburg virus |
Began a trial to test the drug in Angola (4/26) |
The Immune |
Remune |
Immune-based therapy comprised of a whole-killed virus and an adjuvant |
HIV |
Phase II trial in 49 patients in Italy showed CD4+ cell counts remained stable through week 28 in drug patients, but declined in control groups (4/21) |
Ipsat Therapies* |
P1A |
Product designed to inactivate beta-lactam antibiotics in the lower intestinal tract |
Antibiotic resistance |
Phase IIa trial showed prevention of bacterial resistance and other side effects, and demonstrated safety (4/5) |
MISCELLANEOUS | ||||
Ark |
EG005 |
Agent designed to to increase the ability of mitochondria to produce energy |
Lipodystrophy |
Encouraging trends were seen in Phase II trial and open-label extension phase in HIV patients (4/14) |
Genaera |
Lomucin |
Talniflumate; anti- inflammatory drug with activity against the hCLCA1 chloride channel |
Cystic fibrosis |
Began pivotal Phase II trial in Ireland to evaluate safety and efficacy on pulmonary function and related symptoms in 200 patients (4/18) |
Hollis-Eden |
Neumune |
Immune-regulating hormone |
Acute radiation syndrome |
Began a Phase I trial in the Netherlands to test safety and pharmacokinetic (4/1) |
Isotechnika |
ISA247 |
Immunosuppressive agent |
For use in kidney transplantation |
Starting a Phase IIb trial in Canada to compare the drug to tacrolimus in 332 newly transplanted patients (4/28) |
Insmed Inc. |
SomatoKine |
Composition of insulin- like growth factor-1 and its primary binding protein, BP3 |
Extreme insulin resistance |
Began a Phase II trial in the UK to evaluate safety and efficacy for 16 weeks in 10 patients (4/26) |
Pharmagene |
PGN1164 |
Oral 5HT2B antagonist |
Irritable bowel syndrome |
Stopped development of the drug after a Phase I UK trial showed variable pharmacokinetics (4/29) |
Spectrum |
SPI-153 (D-63153) |
Fourth-generation luteinizing hormone- releasing hormone |
Benign prostatic hypertrophy |
Began a Phase II trial in Europe to evaluate safety and efficacy (4/13) |
| | ||||
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; LSE = London Stock Exchange; PK = Pink Sheets; TSE = Toronto Stock Exchange. | ||||
