Company* |
Product |
Description |
Indication |
Status (Date) |
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CANCER | ||||
Abgenix Inc. |
ABX-EGF |
Fully human monoclonal antibody against the epidermal growth factor receptor |
Colorectal cancer |
Company began a Phase II trial (1/8) |
Alfacell Corp. |
Onconase |
Cytotoxic ribonuclease; member of the super- |
Inoperable malignant mesothelioma |
Phase II data showed the one- and two-year survival rates overall were 34.3% and 21.6%, respectively, for the 105 patients treated with Onconase (1/22) |
AltaRex Corp. |
OvaRex |
Oregovomab; a fully foreign monoclonal antibody that targets CA125 |
Ovarian cancer |
Phase IIb trial results were mixed with time before relapse being up to seven months in the U.S. trial, and up to two months in the Canadian trial (1/25); the combined results were positive and statistically significant overall (1/31) |
Aphton Corp. |
G17DT |
Anti-G17 immunogen |
Metastatic gastric cancer |
Company completed patient recruitment in a trial of a combination therapy of G17DT and 5-FU plus cisplatin (1/23) |
Dendreon |
Provenge |
Therapeutic vaccine |
Prostate cancer |
Phase III data indicate that Provenge will not meet its primary endpoint of time to disease progression (1/11) |
Human Genome |
Albuleukin |
A novel recombinant human protein |
Cancer |
The company will begin a Phase I trial in patients with solid tumors (1/7) |
IDEC Pharma- |
Zevalin |
Radiolabeled mouse monoclonal antibody targeted against the CD20 antigen; ibritumomab tiuxetan |
Non-Hodgkin's lymphoma |
FDA told the company Zevalin is approvable pending resolution of certain manufacturing compliance issues at the company's fill/finish provider, Catalytica Pharmaceuticals Inc. (1/9) |
Interferon |
Alferon N |
Natural-source, multispecies alpha interferon |
To prevent metastatic recurrences of cancer after surgical removal of tumors |
Company began a clinical study (1/8) |
Isis Pharma- |
LY900003 |
Antisense agent that uses the genetic code to prevent the production of disease-causing proteins |
Non-small-cell lung cancer |
Company completed enrollment of 600 patients in a Phase III trial (1/16) |
Maxim Pharma- |
Ceplene |
Histamine |
Advanced metastatic |
Phase III results showed that use of Ceplene as an adjunct to IL-2 is safe, well tolerated and associated with a statistically significant prolongation of survival compared with IL-2 alone (1/9); company initiated a Phase III trial with Ceplene and IL-2 in patients with liver metastases (1/17) |
MGI Pharma |
Palonosetron |
A 5-HT antagonist |
Chemotherapy- induced nausea and vomiting |
Company reported that patient treatment is completed in the pivotal Phase III trials (1/16) |
MGI Pharma |
MG98 |
A second-generation antisense inhibitor of DNA methyltransferase |
Advanced myelodysplasia and relapsed or refractory acute myeloid leukemia |
Companies began a clinical trial of MG98 (1/29) |
Millennium |
MLN341 |
Anticancer agent designed to specifically block the proteasome |
Solid tumors |
Company began multiple Phase I trials of MLN341 in combination with taxotere (1/7) |
NeoRx Corp. |
Pretarget |
Targeted therapeutic that deliver intense doses of anticancer agents to tumor cells while sparing healthy tissue |
Non-Hodgkin's lymphoma and gastrointestinal adenocarcinoma |
Company completed enrollment in a Phase Ia trial in lymphoma, and initiated enrollment in a Phase Ia trial in gastrointestinal adenocarcinoma (1/2) |
NeoTherapeu- |
Neotrofin |
Nerve regeneration drug |
Chemotherapy- induced neuropathy |
Company started two Phase II trials (1/9) |
NewBiotics |
NB1011 |
Derived from NewBiotics' Enzyme Catalyzed Therapeutic Activation technology |
Colon cancer |
Company began a Phase I/II trial (1/7) |
Pharmacyclics |
Xyctrin |
Motexafin gadolinium |
Brain cancer metastasis |
Xcytrin missed its co-primary endpoints in a Phase III trial (1/8) |
Telik Inc. |
TLK286 |
Small-molecule drug candidate in development for cancers that are refractory to standard treatments |
Breast cancer |
Company completed a Phase I trial (1/8) |
CARDIOVASCULAR |
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Alexion Pharma- |
Pexelizumab |
An anti-inflammatory C5 inhibitor monoclonal antibody fragment |
Myocardial infarction |
The drug entered a 3,000-patient Phase III study (1/7); company completed enrollment in a 900-patient Phase II study (1/15) |
Cardiome |
RSD1235 |
Anti-arrhythmic drug |
Atrial fibrillation |
Company began patient dosing in a Phase II study (1/17) |
Emisphere |
|
An oral heparin solution formulation; sodium-N- [8-(2-hydroxybenzoyl) amino] caprylate delivery agent |
Deep-vein thrombosis following total hip replacement surgery |
Enrollment of the PROTECT trial with 2,292 patients was completed (1/7) |
Genaissance |
Lovastatin |
Cholesterol-lowering |
High cholesterol |
Company completed enrollment of its second clinical trial (1/15) |
Scios Inc. |
Natrecor |
Nesiritide |
Chronic advanced congestive heart failure |
Company began enrolling patients in a pilot study (1/4) |
CENTRAL NERVOUS SYSTEM | ||||
Amarin Corp. |
LAX-101 |
Compound that inhibits certain harmful enzymes including phospholipases and caspases |
Huntington's |
Phase II data showed a mean 34% improvement for patients receiving LAX-101 vs. a mean 23% decline for the patients receiving placebo (1/23) |
DIABETES |
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Amylin Pharma- |
AC2993 |
Synthetic exendin-4 |
Type II diabetes |
Study results showed that sustained, continuous, subcutaneous infusion lowered both pre-meal and post-meal glucose concentrations throughout the day (1/3); company started the second of three Phase III trials (1/30) |
Insmed Inc. |
SomatoKine |
Recombinant protein being developed as an insulin sensitizer |
Type II diabetes |
Company reported positive results in a Phase II trial, showing improvements in insulin sensitivity and fasting blood glucose (1/8) |
ISTA Pharma- |
Vitrase |
Injectable enzyme; hyaluronidase |
Diabetic |
Phase IIa results showed that complete posterior vitreous detachments were documented in 60% of eyes treated with a single dose of Vitrase, compared with only 6% of patients in the saline control group (1/7) |
Neurocrine |
NBI-6024 |
Vaccine with potential to stop the destruction of insulin-secreting beta islet cells |
Type I diabetes |
Companies began a Phase IIb trial (1/3) |
Peptor Ltd. |
DiaPep277 |
Synthetic version of P277, a peptide derived from hsp60, a 60kDa heat-shock protein |
Type I diabetes |
Company plans to begin a Phase II trial in the U.S. (1/14) |
INFECTION |
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Amerimmune |
Cytolin |
Monoclonal antibody that blocks certain adhesion molecules |
HIV |
Company reported that a Phase Ib trial is in progress (1/14) |
BioCryst Pharm- |
Peramivir |
Orally active small molecule |
Flu |
Company began Phase III enrollment in the U.S. (1/3) |
Corixa Corp. |
RC-529 |
Synthetic adjuvant used in combination with Rhein's yeast Hansenula polymorpha- based recombinant hepatitis B antigen |
Hepatitis B |
Companies reported statistically significant results of a Phase III trial (1/9) |
Cubist Pharma- |
Cidecin |
Daptomycin for injection |
Community- |
Cidecin failed to meet its primary endpoint in the first of two Phase III trials (1/16) |
InterMune |
Actimmune |
Interferon gamma-1b injection |
Severe liver fibrosis, or cirrhosis, caused by hepatitis C virus |
Company began enrolling patients in a Phase II trial (1/8) |
Triangle Pharma- |
Coactinon |
Emivirine; non-nucleoside reverse transcriptase inhibitor |
HIV infection |
Company terminated further development because Coactinon was not performing as well as its comparator drug, abacavir, across the full study population (1/18) |
Versicor Inc. |
Anidula- |
Intravenous infusion |
Aspergillosis |
Company began a Phase III trial in aspergillosis, a life-threatening fungal infection (1/7) |
XTL Biopharm- |
XTL-002 |
A fully human, high-affinity monoclonal antibody |
Hepatitis C |
Company reported positive results, with eight out of 15 patients experiencing reduction of HCV viral load (1/14) |
INFLAMMATION AND PAIN | ||||
aaiPharma Inc. |
ProSorb-D |
Diclofenac pain product |
Pain |
Company enrolled and dosed the first group of patients in a Phase II/III trial (1/9) |
Abgenix Inc. |
ABX-IL8 |
Moncolonal antibody generated with Abgenix's XenoMouse technology; it blocks interleukin-8, a chemokine |
Rheumatoid |
The Phase IIa study failed to meet its endpoints; the company has abandoned development plans in the RA indication (1/4) |
Alexion Pharm- |
5G1.1 |
Humanized monoclonal antibody C5 complement inhibitor |
Rheumatoid |
Company began its first Phase IIb trial (1/29) |
A.P. Pharma |
APF 112 |
Incorporates mepivacaine and the Biochronomer bioerodible drug delivery system |
Post-surgical pain |
Company completed its initial Phase I trial; results indicated the drug caused no adverse events in 16 subjects (1/29) |
Pozen Inc. |
MT 300 |
An injectable dihydro- |
Severe migraine |
Pozen began the final Phase III pivotal trial of MT 300 (1/31) |
Regeneron |
Interleukin- |
Highly potent blocker of interleukin-1 |
Rheumatoid |
Phase Ib results showed dose-dependent improvements in tender and swollen joints and C-reactive protein levels (1/7) |
MISCELLANEOUS |
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Connetics |
Olux |
Clobetasol propionate |
Mild-to-moderate non-scalp psoriasis |
Phase IV results showed 71% of treated patients had complete or almost complete clearance of disease, compared with 22% treated with placebo (1/29) |
Genaera |
Squalamine |
Anti-angiogenic agent with a multifaceted mechanism of action that blocks the action of a number of angiogenic growth factors, including vascular endothelial growth factor |
Fibrodysplasia |
Company began a clinical trial of squalamine (1/16) |
Human |
Repifermin |
Keratinocyte growth |
Chronic venous ulcers |
Phase IIa results showed patients achieved 75% wound closure within a 12-week duration; repifermin was well tolerated (1/29) |
Idun Pharma- |
IDN-6556 |
Small-molecule caspase protease inhibitors |
Liver disease |
Phase I results showed it was safe and well tolerated (1/31) |
Inspire Pharma- |
INS365 Ophthalmic |
An eye drop that works by activating the P2Y receptor |
Dry eye |
Phase III results indicate the eye drop did not meet the primary efficacy endpoint (1/16) |
La Jolla Pharm- |
LJP 394 |
Arrests the production of antibodies to dsDNA without suppressing the healthy functions of the immune system |
Lupus renal |
Phase II/III data showed improved or sustained health-related quality of life in patients with lupus renal disease (1/10) |
Miravant |
PhotoPoint |
Photodynamic therapy |
Plaque psoriasis |
Company began treating patients in a Phase II trial (1/9) |
Miravant Medical |
SnET2 |
Tin ethyl etiopurpurin; photodynamic therapy |
Subfoveal choroidal neovascularization |
Phase III data showed it did not meet its primary efficacy endpoint (1/14) |
Neurocrine |
NBI- |
Modified-release tablets |
Insomnia |
Company saw positive efficacy results in a Phase II study; the tablets demonstrated a statistically significant improvement in sleep efficiency (1/18) |
Regeneron |
Axokine |
Genetically re-engineered version of a naturally occurring human protein known as ciliary neurotrophic factor |
Obesity |
Company completed enrollment in a Phase III trial (1/10) |
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Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
LSE = London Stock Exchange; OTC BB = Over the Counter Bulletin Board; TSE = Toronto Stock Exchange |