Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
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AUTOIMMUNE | ||||
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Amgen Inc. (AMGN) |
Enbrel |
Etanercept; tumor necrosis factor inhibitor |
Psoriasis |
Phase III data showed that 49% of patients treated with 50 mg twice weekly achieved at least a 75% improvement, compared to placebo, after three months (3/21) |
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Angiotech Pharmaceuticals Inc. (Canada; ANPI) |
Paxceed |
A Cremophor EL-free paclitaxel formulation |
Psoriasis |
Phase I data showed all nine patients had a positive response (3/19) |
Centocor Inc. (unit of Johnson & Johnson) |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha |
Psoriasis |
Phase II data showed 88% and 72% of patients treated with 5 mg/kg and 3 mg/kg of Remicade, respectively, experienced a greater than or equal to 75% improvement from baseline in Psoriasis Area Severity Index score, compared to 6% of placebo patients (3/21) |
Genentech Inc. (NYSE:DNA) and XOMA Ltd. (XOMA) |
Raptiva |
Efalizumab; recombinant humanized monoclonal antibody |
Psoriasis |
Phase III data showed that after 12 weeks of Raptiva therapy, 27% of patients demonstrated 75% or greater Psoriasis Area Severity Index score improvement, compared to 4% of placebo patients (3/21) |
Isotechnika Inc. (Canada; TSE:ISA) |
ISA247 |
Immunosuppressive candidate |
Psoriasis |
Phase II data showed that ISA247 met or exceeded all primary and secondary efficacy and safety endpoints in patients with moderate to severe psoriasis (3/10) |
La Jolla Pharmaceutical Co. (LJPC) |
Riquent |
B-cell toleragen; arrests the production of antibodies to dsDNA without suppressing healthy functions of the immune system |
Lupus renal disease |
Phase III data showed that Riquent lowers levels of antibodies to dsDNA in a statistically significant manner, although the trial did not reach statistical significance for its primary endpoint, time to renal flare (3/31) |
CANCER | ||||
Aphton Corp. (APHT) |
G17DT |
Vaccine-like product that blocks the hormone gastrin 17 |
Pancreatic cancer |
Phase III data showed a statistically significant overall median survival benefit of 83% for G17DT (3/4) |
AVI BioPharma Inc. (AVII) |
Neugene |
Antisense drug targeting the oncogene c-myc |
Cancer |
Company completed Phase I trials (3/26) |
Celgene Corp. (CELG) |
Thalomid |
Thalidomide; modulates levels of tumor necrosis factor alpha |
Multiple myeloma |
Data from the first pilot trials revealed a reduction in complex regional pain syndrome symptoms in three patients who continued with therapy for three months (3/21) |
Cell Pathways Inc. (CLPA) |
Aptosyn |
Exisulind; small-molecule compound that augments apoptosis in precancerous cells |
Non-small-cell lung cancer |
Company completed enrollment in a Phase III trial of Aptosyn in combination with Taxotere (3/6) |
CuraGen Corp. (CRGN) |
CG53135 |
A protein therapeutic |
Oral mucositis following chemotherapy |
Company will begin a Phase I trial (3/4) |
FeRx Inc.* |
MTC-DOX |
Magnetic Targeted Carrier drug delivery platform |
Hepatocellular carcinoma |
Phase I/II data showed that tumor localization of MTC-DOX was achieved in 31 of 33 patients and measurements of doxorubicin in plasma were undetectable or low (3/31) |
Isis Pharmaceuticals Inc. (ISIS) |
Affinitak |
Inhibitor of protein kinase C-alpha expression |
Non-small-cell lung cancer |
Phase III data showed the drug failed to meet its primary end-point (3/17) |
Oncolytics Biotech Inc. (Canada; TSE:ONC) |
Reolysin |
A human, reovirus-based product |
Prostate cancer |
Clinical results showed evidence of viral activity in five of six patients, and there were no safety concerns (3/31) |
Oxford BioMedica plc* (UK) |
TroVax |
Cancer gene therapy product |
Colorectal cancer |
Company will begin a Phase II trial in up to 15 patients receiving chemotherapy for the first time to treat metastatic or inoperable cancer (3/3) |
SuperGen Inc. (SUPG) |
Decitabine |
Inhibits DNA methyl-transferase activity |
Advanced myelodysplastic syndrome |
Company completed patient enrollment in a Phase III trial (3/17) |
SuperGen Inc. (SUPG) |
Decitabine |
Inhibits DNA methyl-transferase activity |
Leukemia |
Phase I data showed that 21 of 23 patients achieved disease remission, with six of them alive and disease free as of May 2002 at a median of 3.3 years after stem cell transplantation; the median survival for the whole group was 17.2 months and disease-free survival was 8.9 months (3/31) |
Telik Inc. (TELK) |
TLK286 |
A small-molecule antitumor drug that is activated by GST-P1-1 |
Ovarian cancer |
Company began a Phase III trial (3/27) |
Tularik Inc. (TLRK) |
T67 |
A drug that binds irreversibly to beta-tubulin |
Hepatocellular carcinoma |
Company enrolled the first patient in the registration trial of T67 (3/25) |
Vion Pharmaceuticals Inc. (VION) |
Triapine |
Inhibitor of ribonucleotide reductase |
Advanced leukemia |
Company initiated a Phase I trial of Triapine in combination with cytarabine (3/31) |
YM BioSciences Inc. (Canada; AIM:YMB; TSE:YM_PB) |
Tesmilifene |
Designed to enhance the chemotherapeutic effects of anthracyclines and taxanes |
Advanced metastatic or recurrent breast cancer |
Company will begin a Phase III trial (3/4) |
CARDIOVASCULAR | ||||
Alteon Inc. (AMEX:ALT) |
ALT-711 |
A.G.E. crosslink breaker |
Diastolic heart failure |
Phase IIa data showed a reduction in left ventricular mass (3/31) |
AtheroGenics Inc. (AGIX) |
AGI-1067 |
Oral anti-inflammatory drug candidate |
Coronary artery disease |
Company is beginning a Phase III trial in 160 U.S., Canadian and South African cardiac centers to evaluate AGI-1067's impact (3/13) |
Cardiome Pharma Corp. (Canada; OTC BB:COMRF) |
Oxypurinol |
Belongs to a class of drugs that increases the pumping action of the heart without a proportionate increase in oxygen consumption by the organ |
Congestive heart failure |
Company began patient dosing in a Phase II/III study (3/11) |
D-Pharm Ltd.* (Israel) |
DP-b99 |
A neuroprotective agent that was shown to reduce brain infarct volumes and to help in recovery of neurological function |
Acute stroke |
Phase II data indicates that DP-b99 might be safely administered and that improvements were observed in clinical neurological scale scores (3/11) |
Dyax Corp. (DYAX) |
DX-88 |
Kallikrein inhibitor |
Hereditary angioedema |
Phase II data showed that specific inhibition of plasma kallikrein activity by DX-88 might be effective in treating acute symptoms in patients with hereditary angioedema (3/10) |
Hemosol Inc. (Canada; HMSL; TSE:HML) |
Hemolink |
Hemoglobin raffimer; oxygen therapeutic designed to improve oxygen delivery via the circulatory system |
Cardiac bypass grafting surgery |
Hemosol is suspending enrollment in a Phase II trial based on a recommendation by its data safety monitoring board (3/13) |
Medicure Inc. (Canada; TSE:MPH) |
MC-1 |
Cardiovascular drug |
Percutaneous coronary intervention |
Phase II data showed MC-1 was safe and effective as a cardioprotective treatment to reduce damage to the heart associated with acute ischemic and reperfusion injury (3/31) |
Northfield Laboratories Inc. (NFLD) |
PolyHeme |
Oxygen-carrying blood substitute that is derived from human blood but has a longer shelf life |
For use in urgent blood loss |
Northfield plans to proceed with a Phase III trial (3/6) |
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Nuvelo Inc. (NUVO; formerly Hyseq Pharmaceuticals Inc.) |
Alfimeprase |
A modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot |
Peripheral arterial occlusion |
Phase I data showed the product was safe and well tolerated with no related adverse events (3/27) |
Texas Biotechnology Corp. (TXBI) and GlaxoSmithKline plc (UK) |
Argatroban (FDA-approved) |
A direct thrombin inhibitor anticoagulant |
Acute ischemic stroke |
Phase II data supported the tolerability of Argatroban, showing no statistically significant differences between Argatroban and placebo in symptomatic or asymptomatic intracranial hemorrhage (3/5) |
Viron Therapeutics Inc.*(Canada) |
VT-111 |
Anti-inflammatory protein |
Acute coronary syndrome |
Company completed a Phase I trial (3/6) |
CENTRAL NERVOUS SYSTEM | ||||
Cypress Bioscience Inc. (CYPB) |
Milnacipran |
The first of a new class of agents known as NSRIs, or norepinephrine serotonin reuptake inhibitors |
Fibromyalgia syndrome |
Milnacipran was shown to statistically improve a number of primary and secondary hallmark symptoms of fibromyalgia, including occurence/intensity of pain and overall well being (3/21) |
Endo Pharmaceuticals Inc. (ENDP) |
EN3202 |
Extended-release oral form of the opioid oxymorphone |
Severe, chronic low back pain |
Clinical results showed that patients experienced significantly lower pain intensity scores when compared to placebo (3/20) |
Forest Laboratories Inc. (NYSE:FRX) |
Memantine |
A moderate-affinity, uncompetitive N-methyl D-aspartate receptor antagonist that modulates glutamate levels |
Alzheimer's disease |
Clinical results showed no pharmacokinetic interactions between memantine and donepezil (Aricept) (3/10) |
Repligen Corp. (RGEN) |
RG1068 |
Synthetic human secretin |
Autism |
Company is beginning an open-label extension of its ongoing Phase III trials (3/25) |
DIABETES | ||||
Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co. |
Exenatide LAR (formerly AC2993) |
Sustained-release, subcutaneous injection of exenatide |
Type II diabetes |
Phase II data verified that sustained levels of exenatide are possible, supporting the continuation of a clinical program (3/19) |
Aradigm Corp. (ARDM) |
AERx iDMS |
Insulin Diabetes Management System |
Diabetes |
Phase II data showed it was safe, well tolerated and produced reproducible dosing in smokers and patients with asthma (3/17) |
Biovitrum AB* (Sweden) |
BVT.3498 |
Highly selective inhibitor of the enzyme 11betaHSD1, yielding reduced tissue levels of cortisol |
Type II diabetes |
Company began a Phase II trial (3/25) |
Flamel Technologies SA (France; FLML) |
Basulin |
Long-acting, subcutaneously administered formulation of human insulin based on Flamel's Medusa technology |
Diabetes |
Company reported positive results from a second trial showing Basulin provided at least the same efficacy and a similar pharma cokinetic profile as another long-acting insulin product, Lantus (3/27) |
Ortec International Inc. (OTC BB:ORTC) |
OrCel (FDA-approved) |
Bilayered cellular matrix; collagen sponge seeded with allogeneic epidermal and dermal cells |
Diabetic neuropathic foot ulcers |
Clinical data showed that ulcers treated with OrCel had a faster rate of wound healing than those treated with the standard of care alone (3/17) |
INFECTION | ||||
Acambis plc (UK; LSE:ACM) |
ACAM2000 |
Vaccine |
Smallpox |
Phase I data showed that 99% of patients achieved the accepted indication of protective immunogenicity - the development of a pockmark on the skin (3/11) |
Anadys Pharmaceuticals Inc.* |
ANA245 |
Antiviral that elevates levels of interferon-alpha and provides antiviral and antimetastatic activity in a variety of murine systems |
Hepatitis C |
Company completed a Phase Ia study (3/3) |
Bavarian Nordic A/S (Denmark; CSE:BAVA) |
MVA-BN nef |
Vaccine |
HIV |
Phase I/II results showed that up to 11 months after stopping anti-retroviral therapy, the levels of HIV in seven patients remained below their pre-therapy level (3/5) |
BioMarin Pharmaceutical Inc. (BMRN) |
Aryplase |
Recombinant human arylsulfatase B; enzyme replacement therapy |
Mucopolysac- charidosis VI |
Phase II data indicated that Aryplase was well tolerated and associated with improvements in several clinical endpoints (3/14) |
CollaGenex Pharmaceuticals Inc. (CGPI) |
Metastat |
Orally active angiogenesis inhibitor |
HIV-related Kaposi's sarcoma |
Company completed enrollment in a Phase II study (3/28) |
Cytovax Biotechnologies Inc. (Canada; TSE:CXB) |
Cytovaxine |
A peptide vaccine that uses the company's AntiAdhesin Technology to prevent infection |
To prevent infection caused by Pseudomonas aeruginosa |
Company completed a Phase I trial of Cytovaxine (3/28) |
Pharmasset Inc.* |
Racivir |
Nucleoside antiviral agent |
HIV |
Phase Ib/IIa data showed favorable results (3/26) |
Versicor Inc. (VERS) |
Anidulafungin |
Intravenous infusion |
Esophageal candidiasis |
Phase III data showed the drug hit its primary endpoint, demonstrating the antifungal agent's non-inferiority to fluconazole; it did not meet a secondary end-point when its relapse rate was at 35.6% compared to 10.5% for fluconazole (3/18) |
MISCELLANEOUS | ||||
Alkermes Inc. (ALKS) |
Vivitrex |
A formulation of naltrexone based on Alkermes' Medisorb injectable |
Alcohol dependence |
Company completed enrollment of more than 600 patients in its pivotal Phase III trial (3/31) |
Arriva Pharmaceuticals Inc.* and Baxter Healthcare Corp. |
-- |
Alpha 1-antitrypsin therapy |
Hereditary emphysema |
Companies began a Phase I trial (3/4) |
BioSante Pharmaceuticals Inc. (OTC BB:BISP) |
Bio-E-Gel |
Estradiol topical gel |
Menopausal symptoms (hot flashes) |
Company completed its Phase II/III trial of Bio-E-Gel (3/3) |
Dynavax Technologies Corp.* |
AIC |
Anti-allergy immunotherapy |
Ragweed allergy |
Phase II data showed AIC appears to provide protection against ragweed allergy (3/11) |
Dynavax Technologies Corp.* |
ISS |
Immuno-stimulatory DNA sequence |
Asthma |
Phase I data demonstrated the safety and biological activity of its inhaled ISS to treat asthma (3/7) |
Genzyme General (GENZ) |
Myozyme |
Recombinant human acid alpha-glucosidase enzyme |
Pompe disease |
Company began enrollment in a U.S. and European trial (3/19) |
Inspire Pharmaceuticals Inc. (ISPH) |
INS37217 Intranasal |
A non-preserved nasal spray formulation |
Perennial allergic rhinitis |
Company completed enrollment in a 630-patient trial (3/6) |
MediWound Ltd.* (Israel) |
Debrase Gel Dressing |
Engineered from pineapple stems |
Thermal burns |
Company began Phase IIb trials in the U.S. and Europe (3/5**) |
NicOx SA (France; Nouveau Marche:NICOX) |
AZD3582 |
First of a new class of analgesic and anti-inflammatory drugs known as COX-inhibiting nitric oxide donators |
Gastrointestinal ulcers |
Phase II data showed AZD3582 failed to meet its primary end-point, but the company said that due to a lower than predicted rate of gastrointestinal ulcers in the group treated, the study was underpowered; the compound met secondary endpoints (3/11) |
Regeneron Pharmaceutical Inc. (REGN) |
Axokine |
Genetically reengineered version of a naturally occurring human protein known as ciliary neurotrophic factor |
Obesity |
Axokine met primary and secondary endpoints in a Phase III trial, but the incidence of neutralizing antibodies was 70% (3/31) |
Tanox Inc. |
TNX-901 |
A humanized anti-IgE antibody |
Peanut allergy |
Phase II data were positive (3/11) |
Vivus Inc. |
Alista |
Formulation of alprostadil applied locally to the female genitalia |
Female sexual arousal disorder |
Company began recruitment for a Phase II trial (3/17); clinical results showed a statistically significant improvement in the primary endpoint of satisfactory sexual arousal and/or orgasm in the 400-mg dose group; results in the 200-mg and 800-mg dose groups demonstrated positive trends for the primary end-point but did not reach statistical significance (3/31) |
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Notes: | ||||
* Privately held company | ||||
** Denotes the date the item ran in BioWorld International. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AIM = Alternative Investment Market of the London Stock Exchange; AMEX = American 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 | ||||
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