Company* |
Product |
Description |
Indication |
Status |
| ||||
AUTOIMMUNE | ||||
AtheroGenics |
AGIX-4207 |
Oral treatment; an |
Rheumatoid arthritis |
Phase II data showed the treatment inhibited by 92% the increase in erythrocyte sedimentation rate observed in placebo patients; the treatment was safe and well tolerated (7/16) |
Biogen Inc. |
Antegren |
Natalizumab; a |
Crohn's disease |
Phase III data showed Antegren did not meet its primary endpoint of a response, although it did show biological activity similar to what was seen in earlier Phase II work (7/24) |
Can-Fite |
CF101 |
A synthetic agonist that |
Rheumatoid arthritis |
Company initiated a Phase II trial (7/23) |
Genentech Inc. (NYSE:DNA) and XOMA |
Raptiva |
Efalizumab; recombinant humanized monoclonal antibody |
Moderate to severe plaque psoriasis |
Phase III data showed that 44% of 368 patients treated with Raptiva for up to 24 weeks achieved a 75% or greater improvement in their Psoriasis Area and Severity Index score (7/28) |
Merrimack Pharmaceuticals Inc.* |
MM-093 |
A recombinant version of human alpha-fetoprotein |
Autoimmune diseases |
Company began a Phase I trial (7/29) |
|
||||
Neurocrine Biosciences Inc. (NBIX) |
NBI-5788 |
An altered peptide ligand |
Relapsing |
Company began a Phase II trial (7/28) |
|
||||
Vertex Pharmaceuticals |
Pralnacasan |
Oral anti-cytokine therapy; |
Rheumatoid arthritis |
Company began enrollment in a Phase IIb trial in the U.S. and Canada (7/10) |
|
||||
CANCER | ||||
BTG (unit of |
BGC 9331 |
A non-polyglutamatable thymidylate synthase |
Gastric cancer |
Company began a Phase I/II trial (7/11) |
|
||||
Cancer Vac (subsidiary of |
-- |
Immunotherapy |
Advanced |
Phase Ib data showed no significant side effects; the therapy is showing positive effects on tumors in some patients (7/15) |
|
||||
Cel-Sci Corp. (AMEX:CVM) |
Multikine |
Immunotherapy drug; |
Primary head and neck cancer |
Phase I/II data showed that the use of Multikine prior to surgical intervention made the residual tumor cells more susceptible to follow-on treatment with radiation and possibly chemotherapy (7/9) |
Curacyte AG* (Germany) |
PHP |
Pyridoxalated hemoglobin polyoxyethylene |
Metastatic renal cell carcinoma or melanoma |
Company will begin a Phase I trial in the U.S. (7/23**) |
|
||||
Cyclacel |
CYC202 |
R-roscovitine; a CDK |
Cancer |
Clinical data showed the drug induced cancer cell apoptosis, and seven patients with various tumors experienced stabilization (7/14) |
Dendreon |
APC8024 |
Immunotherapy; |
Breast, colon |
Phase I data showed continued clinical benefit (7/14) |
|
||||
Enzon |
PEG- |
Prodrug form of the topoisomerase inhibitor camptothecin; prodrug |
Gastric and gastroesophageal junction cancers |
Phase II data showed PEG-Camptothecin met its safety and efficacy criteria and will be advanced for the indication (7/24) |
|
|
|||
Genta |
Genasense |
Oblimersen sodium; |
Chronic lymphocytic leukemia |
Company began a Phase II trial of Genasense in combination with Rituxan and fludarabine (7/30) |
|
||||
IVAX Corp. (AMEX:IVX) |
Talampanel |
Blocks the effect of |
Brain cancer |
Company began a |
|
||||
Millennium Pharmaceuticals |
MLN944 |
A DNA-targeting agent that demonstrated anti-tumor activity |
Advanced solid tumors |
Companies initiated a Phase I trial (7/3) |
|
||||
Millennium Pharmaceuticals |
Velcade |
Blocks the proteasome, an enzyme complex involved in degrading proteins that control cellular processes |
Mantle-cell lymphoma |
Company initiated a |
|
||||
Onyvax |
Onyvax-P |
Cancer vaccine consisting |
Prostate cancer |
Phase IIa data showed that 20 out of 26 patients had no evidence of clinical deterioration, with a median time to progression of the disease projected in excess of 48 weeks (7/3) |
|
|
|||
Oxford |
MetXia |
Cancer gene therapy products; MetXia delivers the gene CYP286 directly to solid tumors, where it generates an enzyme that converts the prodrug cyclophosphamide into its active, cytotoxic form |
Breast cancer |
Phase I/II data were positive (7/3) |
|
||||
Oxford |
TroVax |
TroVax is based on a gene for the tumor-associated antigen OBA1 |
Colorectal |
Phase I/II data of the intradermal delivery of TroVax showed all primary endpoints were achieved (7/14) |
|
||||
Phoenix Pharmacologics |
Arginine deiminase |
A protein; an enzyme that degrades the amino acid arginine |
Hepatocellular carcinoma |
Phase II data showed that two of 19 patients were in complete remission without any clinical evidence of disease; seven experienced a greater-than-50% remission of their tumor, and seven had stable disease (7/24) |
Point |
PT-100 |
Orally active small |
B-cell hematologic malignancies |
Company enrolled the first patient in a Phase I/II trial investigating PT-100 and Rituxan (7/8) |
|
|
|||
Progen Industries Ltd. (Australia; PGLAF) |
PI-88 |
Semi-synthetic sulfated oligosaccharide that has several modes of action |
Multiple |
Company completed a Phase II trial, which achieved the primary efficacy endpoints (7/8) |
|
|
|||
SuperGen Inc. (SUPG) |
Dacogen |
Decitabine; inhibitor of DNA methyltransferase |
Chronic myelogenous leukemia |
Phase II data showed there was no significant difference in the response rates among dose levels in the accelerated and blastic phase patients (7/30) |
SuperGen Inc. (SUPG) |
Nipent |
Pentostatin for injection |
Non-Hodgkin's lymphoma |
Phase II data |
|
|
|
||
TransMolecular Inc.* |
131-I-TM-601 |
Radiopharmaceutical containing a synthetic |
Glioma |
Company completed enrollment in a Phase I/II trial (7/10) |
|
|
|||
Vion |
VNP4010M |
DNA-damaging agent |
Advanced leukemia |
Company initiated a Phase I trial (7/23) |
|
|
|
|
|
CARDIOVASCULAR | ||||
Agenix Ltd. |
ThromboView |
Blood clot imaging agent |
Deep-vein thrombosis |
Phase Ib data showed ThromboView successfully detected a deep-vein thrombosis of a patient; it also was shown to be safe and well tolerated (7/10) |
Alteon Inc. (AMEX:ALT) |
ALT-711 |
A.G.E. (advanced glycation end-product) crosslink breaker |
High blood pressure |
Phase II data showed ALT-711 missed its primary endpoint and did not demonstrate statistical significance in the reduction of systolic blood pressure (7/17) |
|
|
|||
Amylin Pharmaceuticals |
AC2592 |
Uses a continuous subcutaneous infusion of glucagon-like peptide-1 |
Congestive |
Phase II data showed general improvement in a composite score designed to quantify quality of life and cardiac function while receiving study medication (7/29) |
Avant Immunotherapeutics Inc. (AVAN) |
CETi-1 |
Cholesterol ester transfer protein vaccine |
To raise HDL cholesterol |
Phase I data support the feasibility, immunogenicity and safety of CETi-1 (7/17) |
|
|
|
||
Esperion Therapeutics |
ETC-1001 |
Small molecule |
Lipid disorders |
Company began a Phase I trial (7/25) |
|
|
|
||
Valentis |
Del-1 |
Angiogenesis gene |
Peripheral |
Company initiated a Phase II trial (7/17) |
|
|
|
||
Vasogen Inc. (AMEX:VSV) |
-- |
Immune modulation |
Heart failure |
Company began |
|
|
|||
CENTRAL NERVOUS SYSTEM | ||||
Celgene Corp. (CELG) |
Focalin LA (FDA- |
Dexmethylphenidate hydrochloride extended-release |
Attention |
Company began a |
|
|
|
|
|
Ionix Pharmaceuticals Ltd.* |
IX-1003 |
Intranasal formulation |
Post-operative pain |
Company completed |
|
|
|
||
NeuroSearch A/S (Denmark; CSE:NEUR) |
NS2359 |
Enhances the activity |
Attention deficit hyperactivity disorder |
Company concluded a Phase I trial (7/23**); it began a Phase II study (7/28) |
|
|
|
||
SkyePharma plc (UK; SKYE) and GlaxoSmithKline plc (UK) |
Requip |
Oral, controlled-release version that uses SkyePharma's drug |
Parkinson's disease |
Companies began |
|
|
|
|
|
INFECTION | ||||
AEterna Laboratories Inc. (Canada; AELA) |
Impavido |
Miltefosine |
Leishmaniasis |
Phase III data showed a higher cure rate for patients treated with Impavido than those patients in the placebo group (7/29) |
|
|
|||
Gilead Sciences |
Emtriva |
Emtricitabine; |
HIV |
Phase III data showed |
|
|
|||
Hemispherx Biopharma Inc. (AMEX:HEB) |
Ampligen |
Immunotherapeutic; double-stranded |
HIV |
Phase IIb data showed that patients who have completed at least nine months of Ampligen therapy were able to stay off HAART regimens for a mean of 29 weeks, while a control group had earlier HIV rebound with a mean duration of 18.7 weeks (7/15) |
|
|
|
||
Immtech International Inc. (AMEX:IMM) |
DB289 |
Oral anti-infective; |
Malaria |
Company completed enrollment of patients in a Phase IIa trial (7/11) |
|
||||
Maxim Pharmaceuticals |
Ceplene |
Histamine |
Hepatitis C |
Company completed enrollment in a Phase II |
|
|
|||
Micrologix Biotech Inc. (Canada; TSE:MBI) |
MBI 226 |
A cationic peptide |
Bacterial and fungal bloodstream infections |
Company failed to hit its endpoint in a Phase III |
|
|
|||
Savient Pharmaceuticals |
Prosaptide |
A peptide derived |
Neuropathic |
Company initiated patient screening for a Phase II study (7/31) |
|
|
|||
Vertex Pharmaceuticals |
433908 |
Protease inhibitor |
HIV |
Phase III data showed |
|
|
|||
ViroPharma Inc. (VPHM) |
HCV-371 |
Antiviral compound |
Hepatitis C |
Phase Ib results did not show the desired effect, with no impact on hepatitis C virus RNA levels at the dose tested (7/16) |
|
||||
VIRxSYS |
VRX496 |
Lentiviral vector; |
HIV |
Company began dosing |
|
|
|
||
MISCELLANEOUS | ||||
BioMarin Pharmaceutical |
Aryplase |
Enzyme replacement |
Mucopolysacch- aridosis-VI |
Company plans to begin a Phase III trial (7/7) |
|
|
|
|
|
CollaGenex Pharmaceuticals |
COL-3 |
Non-antimicrobial tetracycline derivative |
Rosacea |
Company initiated a |
|
|
|
||
NexMed Inc |
NexACT |
Alprostadil/lidocaine/ NexACT cream |
Premature ejaculation |
Efficacy data showed |
|
|
|
|
|
Ortec |
OrCel |
Bilayered cellular |
Venous leg ulcer |
Company completed patient enrollment in a pivotal trial (7/7) |
|
|
|
|
|
OxiGene Inc. |
Combretastatin A4 Prodrug |
Vascular targeting |
Wet age-related macular degeneration |
Company began a Phase I/II trial (7/2) |
|
|
|||
Palatin |
PT-141 |
Peptide analogue of (alpha)- MSH ([alpha]-melanocyte- stimulating hormone) |
Sexual dysfunction |
Company completed patient enrollment in a Phase IIb at-home study (7/24) |
|
|
|||
Rigel Pharmaceuticals |
R112 |
The first of a new |
Allergic rhinitis |
Company completed a Phase I/II study (7/21) |
|
|
|||
Sucampo Pharmaceuticals Inc.* |
FK-506 |
Tacrolimus, an immuno-suppressive |
Dry-eye syndrome |
Company began a Phase |
|
|
|
|
|
SuperGen Inc. (SUPG) |
Nipent |
Pentostatin for injection |
Chronic graft- vs.-host disease |
Clinical data showed Nipent is active in treating children diagnosed with chronic graft-vs.-host disease refractory to standard therapy (7/28) |
|
|
|
||
Targeted |
tgAAVCF |
Gene therapy product |
Cystic fibrosis |
Company began a |
|
|
|
|
|
Theratechnologies Inc. (Canada; TSE:TH) |
ThGRF |
Growth |
Wasting secondary to hip fracture surgery |
Company completed enrollment in a Phase II study (7/9) |
|
|
|
||
Vectura |
VR004 |
Inhaled |
Erectile dysfunction |
Phase IIa results showed improved erectile performance with a rapid onset of action; drug was tolerable at all doses tested (7/21) |
Vivus |
TA-1790 |
PDE5 inhibitor |
Erectile dysfunction |
Company began |
|
|
|
||
ZymoGenetics |
rFactor XIII |
A protein involved in the stabilization and |
Factor XIII deficiency |
Phase I data showed that the administration of recombinant human Factor XIII appeared to be safe with no serious adverse events (7/14) |
|
|
|||
| ||||
Notes: | ||||
* Privately held | ||||
** Denotes the date the item ran in BioWorld International. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq 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; TSE = Toronto Stock Exchange. |