Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
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AUTOIMMUNE | ||||
Genelabs Technologies Inc. (GNLB) |
Prestara |
Prasterone; GL701; the synthetic equivalent of dehydroepiandrosterone |
Systemic lupus erythematosus |
Clinical data showed Prestara improved or stabilized overall SLE disease activity and symptoms without deterioration (4/3) |
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Ester Neurosciences* (Israel) |
EN101 |
A lead compound in Ester's disease-modifying platform technology for the pre-expression control of a specific variant of the AChE protein |
Myasthenia gravis |
Phase Ib data showed it was an effective and safe therapy (4/1) |
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Human Genome Sciences Inc. (HGSI) |
LymphoStat-B |
A human monoclonal antibody to B-lymphocytestimulator, BlyS |
Systemic lupus erythematosus |
Phase I data demonstrated that LymphoStat-B was well tolerated and biologically active (4/21) |
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SangStat Medical Corp. (SANG) |
RDP58 |
Anti-inflammatory peptide |
Crohn's disease |
Phase II data showed that only 66% of patients treated with 200 mg a day achieved response (4/9) |
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Teva |
Copaxone (FDA-approved) |
Glatiramer acetate injection |
Multiple sclerosis |
Clinical data showed Copaxone doubled the time relapsing-remitting multiple sclerosis patients took to accumulate disability (4/8) |
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CANCER | ||||
Active Biotech AB (Sweden; SSE:ACTI) |
TTS CD2 |
Tumor Targeted Super-antigens |
Non-small-cell lung cancer |
Clinical results show positive survival results with a median survival time of 8.1 months (4/23) |
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Allos Therapeutics Inc. (ALTH) |
RSR13 |
Efaproxiral; a synthetic allosteric modifier of hemoglobin |
Brain metastases |
Phase III data showed it failed to meet a statistical endpoint, but it did demonstrate a survival trend in breast cancer patients (4/23) |
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Antigenics Inc. (AGEN) |
AG-858 |
A personalized heat-shock protein 70 |
Chronic myelogenous leukemia |
Company began a Phase II trial testing it with Novartis AG's Gleevec (4/9) |
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Applied Genetics Inc.* |
Dimericine |
T4N5 liposome lotion; an approach to preventing skin cancer by repairing DNA damage |
To prevent skin cancer |
Clinical data showed dimericine reduces suppression of the immune system caused by solar ultraviolet rays (4/28) |
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CancerVax Corp.* |
Canvaxin |
Therapeutic cancer vaccine; allogeneic, whole-cell vaccine that expresses more than 20 antigens |
Melanoma |
Company resumed enrollment in a Phase III trial after the FDA halted it a year ago due to production questions (4/15) |
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Cell Genesys Inc. (CEGE) |
CG7870 |
An oncolytic virus therapy |
Prostate cancer |
Company initiated a Phase I/II trial (4/22) |
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Cell Genesys Inc. (CEGE) |
GVAX |
Lung cancer vaccine |
Non-small-cell lung cancer |
Company began enrollment in a Phase II trial (4/1) |
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Favrille Inc.* |
Favid |
Vaccine that stimulates the body's immune response against the tumor |
Non-Hodgkin's lymphoma |
Company expanded the Phase II trial of Favid in combination with Rituxan to include patients who have not received prior treatment for low-grade or follicular non-Hodgkin's lymphoma (4/24) |
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Geron Corp. |
Telomerase immunotherapy |
Antigen for cancer prostate cancer |
Metastatic |
Phase I data showed it was well tolerated and resulted in the generation of an anti-telomerase immune response (4/7) |
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Human Genome Sciences Inc. (HGSI) |
Repiferin |
Keratinocyte growth factor-2, KGF-2 |
Cancer therapy-induced mucositis |
Phase II data showed it was well tolerated and had efficacy (4/2) |
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Isis Pharmaceuticals Inc. (ISIS) |
Affinitak |
Inhibitor of protein kinase C-alpha expression |
Non-small-cell lung cancer |
Phase III data showed it did not meet its primary endpoint (4/2) |
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Lorus Therapeutics Inc. (OTC BB:LORFF) |
Virulizin |
Immunotherapeutic drug that stimulates macrophages, monocytes and natural killer cells to attack tumor cells |
Advanced pancreatic cancer |
A pivotal Phase III trial is being expanded to include about 50 sites in North America and Latin America (4/16) |
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MethylGene Inc.* (Canada) |
MG98 |
A second-generation antisense compound designed to inhibit the expression of DNA methyltransferase, an enzyme implicated in tumor growth |
Cancer |
Phase I data showed that MG98 was well tolerated, produced evidence of objective tumor response or disease stabilization in cancer patients and has predictable human pharmacokinetics (4/3) |
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NeoPharm Inc. (NEOL) |
IL13-PE38QQR |
Tumor-targeting agent; a recombinant protein designed to detect and bind to IL-13 receptors, then deliver PE38, a bacterial cytotoxic agent, to destroy tumor cells |
Malignant glioma |
Phase I/II data showed evidence of cytotoxic effects against malignant glioma tumor cells (4/30) |
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OncoGenex Technologies Inc.* (Canada) |
OGX-011 |
An antisense drug designed to inhibit clusterin and therefore help the effectiveness of anticancer agents |
Solid tumors |
Company initiated a second Phase I trial (4/7) |
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OnyVax |
OnyVax-P |
Vaccine consisting of three inactivated cell lines that target a range of prostate cancer-associated antigens |
Prostate cancer |
Company completed patient recruitment in a Phase IIa trial (4/23**) |
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Salmedix Inc.* |
SDX-102 |
L-alanosine; anticancer agent |
Non-small-cell lung cancer, mesothelioma, pancreatic cancer, osteosarcoma and soft tissue sarcoma |
Company began a Phase II trial (4/2) |
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SuperGen Inc. (SUPG) |
Nipent |
Pentostatin for injection |
Chronic lymphocytic leukemia |
Phase II data showed an overall response rate of 74% (4/1) |
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Xcyte |
Xcellerated T Cells technology |
T cells produced using Xcyte's Xcellerate |
Multiple myeloma |
Company began a Phase I/II trial (4/3) |
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CARDIOVASCULAR | ||||
Avant Immunotherapeutics Inc. (AVAN) |
TP10 |
Complement inhibitor |
Patients under-going adult cardiac surgery |
Phase II data showed a treatment benefit to male patients, but no significant benefit to females (4/29) |
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Theratechnologies Inc. (Canada; TSE:TH) |
ThGRF |
A growth hormone-releasing factor analogue |
A catabolic state secondary to chronic obstructive pulmonary disease |
Company completed enrollment in a Phase II trial (4/23) |
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United Therapeutics Corp. (UTHR) |
Remodulin (FDA-approved) |
Treprostinil sodium injection |
Severe pulmonary hypertension |
Clinical data showed long-term therapy improves New York Heart Association function class and exercise tolerance and improves long-term survival (4/14) |
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CENTRAL NERVOUS SYSTEM | ||||
Ascend Therapeutics Inc.* |
Tamogel |
4-hydroxytamoxifen gel |
Cyclical breast pain |
Company began a Phase II trial (4/30) |
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Celltech Pharmaceuticals Inc. (arm of Celltech Group plc; UK; NYSE:CLL) |
Metadate CD (FDA-approved) |
Methylphenidate HCl extended-release capsules, 20 mg |
Attention deficit hyper-activity disorder |
Clinical results showed a comparable treatment effect to Ritalin 10 mg given twice daily (4/22) |
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Forest Laboratories Inc. (NYSE:FRX) |
Memantine |
A moderate-affinity, uncompetitive N-methyl D-aspartate receptor antagonist that modulates glutamate levels |
Alzheimer's disease |
Phase III data showed that memantine enhanced cognitive function when treated in combination with Aricept (4/4) |
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Neurocrine Biosciences Inc. (NBIX) |
Indiplon |
Capsules; acts on the GABA-A receptor |
Insomnia |
Phase III data showed an immediate-release formulation of the drug achieved statistically significant results in primary and secondary endpoints of sleep initiation over about a month (4/22) |
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Pain Therapeutics Inc. (PTIE) |
Oxytrex |
Next-generation version of oxycodone, a painkiller |
Severe osteoarthritic pain |
Company completed patient enrollment in a Phase II trial (4/22) |
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Pharmos Corp. (PARS) |
Dexanabinol |
Non-psychotropic, synthetic analogue of marijuana |
Post-surgical cognitive impairment |
Company began dosing in a Phase IIa study (4/8) |
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Titan Pharmaceuticals Inc. (AMEX:TTP) |
Spheramine |
Cell therapy in development that uses normal human cells attached to microcarriers and is designed to enhance brain levels of dopamine |
Parkinson's disease |
Clinical data showed Spheramine produced on average 41% improvement in motor function (4/2) |
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Vernalis Group plc (UK; LSE:VER) |
Frovatriptan (FDA-approved) |
5-HT 1B/D agonist |
Menstrually associated migraines |
Phase IIIb data showed that it was effective in preventing migraines when administered for six days during the perimenstrual period (4/2) |
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DIABETES | ||||
Regeneron Pharmaceuticals Inc. (REGN) |
Axokine |
Genetically reengineered version of a naturally occurring human protein known as ciliary neurotrophic factor |
Obesity in diabetics |
Phase II data showed statistically significant weight loss in obese people with diabetes (4/14) |
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INFECTION | ||||
Chiron Corp. (CHIR) |
Menjugate |
A conjugate vaccine against Neisseria meningitidis sero group C |
To prevent meningococcal C disease |
Company began a Phase III trial (4/16) |
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Gilead Sciences Inc. (GILD) |
Hepsera (FDA-approved) |
Adefovir dipivoxil 10 mg |
Hepatitis B |
Clinical data showed more than 70% of patients treated with Hepsera showed persistent suppression of HBV DNA viral replication, continued histological improvements and sustained improvements in liver function through 96 weeks (4/10) |
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Hemispherx Biopharma Inc. (AMEX:HEB) |
Ampligen |
Immunotherapeutic; double-stranded synthetic RNA compound poly 1; poly C124 |
HIV |
Phase IIb data showed that patients taken off highly active anti-retroviral therapy but given Ampligen continued to show virus levels below 5,000 copies/ml for a mean time of 25 weeks and counting, while the control group had an HIV rebound with a mean of 13 weeks (4/29) |
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Immtech International Inc. (OTC BB:IMMT) |
DB289 |
Oral anti-infective; dicationic pharmaceutical compound |
AIDS patients with pneumocystis carinii pneumonia |
Company completed a pilot Phase IIa trial that showed improved lung function in 90% of patients (4/10) |
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Inhibitex Inc.* |
Aurexis |
Humanized monoclonal antibody |
Staphylococcus aureus infections |
Company will begin a Phase I trial (4/30) |
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InSite Vision Inc. (AMEX:ISV) |
ISV-403 |
Combines InSite's sustained-release DuraSite technology with a fourth-generation fluoroquinolone |
Ocular bacterial infections |
Company began a Phase I trial (4/30) |
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SciClone Pharmaceuticals Inc. (SCLN) |
Zadaxin |
Thymalfasin, thymosin alpha 1 |
Hepatitis B |
Clinical results showed a 71% long-term sustained response rate achieved after one year of combination therapy with Zadaxin and interferon alpha (4/9) |
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Trimeris Inc. Hoffmann-La Roche Inc. |
Fuzeon |
Enfuvirtide; HIV fusion inhibitor |
HIV |
Phase III data showed responses (TRMS) and seen at 24 weeks were maintained at 48 weeks (4/28) |
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MISCELLANEOUS | ||||
Adolor |
Alvimopan |
Small-molecule opioid receptor antagonist |
Post-operative ileus |
Phase III data showed it hit its primary endpoint (4/2) |
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Biovitrum AB* (Sweden) |
BVT.933 |
A 5-HT2C receptor agonist |
To suppress appetite |
Company started a Phase IIb study (4/7) |
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CollaGenex Pharmaceuticals Inc. (CGPI) |
Periostat (FDA-approved) |
Doxycycline hyclate tablets, 20 mg |
Moderate facial acne |
Phase II data showed that Periostat significantly reduced the number of inflammatory and non-inflammatory lesions, was well tolerated, had no detectable antimicrobial effect on the skin flora and did not increase resistant organisms or overgrowth of opportunistic pathogens (4/22) |
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Connetics Corp. (CNCT) |
Extina |
New drug formulation of 2% ketoconazole in its foam delivery system |
Seborrheic dermatitis |
Phase III data showed a 50% patient response for Extina, a 44% response for Nizoral, a 40% response for placebo foam and a 26% response for placebo cream (4/24) |
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Copernicus Therapeutics Inc.* |
-- |
A nonviral gene transfer system that tightly binds strands of DNA to pass through a cell membrane and into the nucleus |
Cystic fibrosis |
Phase I data showed positive results without significant side effects and a well-tolerated treatment (4/29) |
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Cytos Biotechnology AG* (Switzerland) |
Nicotine-Qß |
Immunodrug |
Smoking addiction |
Company began a Phase I trial (4/23) |
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ICOS Corp. (ICOS) and Eli Lilly and Co. |
Cialis |
A PDE5 inhibitor |
Erectile dysfunction |
Clinical data showed 79% of U.S. men of diverse ethnic origin reported improved erections after treatment with Cialis, compared to 19% for placebo (4/28) |
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Immusol Inc.* |
VIT100 |
Inhibits the growth of cells taken from multiple keloid biopsies as compared to the same keloidal cells treated with a control |
Keloids and hypertrophic scars |
The first patient was treated in a Phase I trial (4/15) |
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Neurochem Inc. (Canada; TSE:NRM) |
Fibrillex |
Anti-amyloid drug |
Secondary AA amyloidosis |
The company received a unanimous recommendation to con- tinue its pivotal Phase II/III trial from an independent Data Safety Monitoring Board (4/10) |
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NicOx SA (France; Nouveau Marche:NICOX) |
NCX1020 |
Nitric oxide-donating derivative of budesonide |
Asthma |
Company began a Phase I trial (4/1) |
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Pain Therapeutics Inc. (PTIE) |
PTI-901 |
Opioid antagonist |
Irritable bowel syndrome |
Company completed enrollment in a pilot study (4/29) |
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Palatin Technologies Inc. (AMEX:PTN) |
PT-141 |
Peptide analogue of (alpha)- MSH ([alpha]-melanocyte- stimulating hormone) |
Erectile dysfunction |
Phase IIa data showed a statistically significant improvement in erectile function across a range of patients with no significant adverse effects (4/28) |
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Progenics Pharmaceuticals Inc. (PGNX) |
Methylnaltrexone |
Designed to reverse the side effects of opioids without interfering with pain relief |
Constipation |
Phase II data showed 60% of patients who received at least a 5 mg mg dose laxated within four hours as compared to less than 8% at lower doses (4/30) |
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RegeneRx Bio-pharmaceuticals Inc. (OTC BB:RGRX) |
Thymosin beta 4 |
A naturally occurring 43-amino-acid peptide |
Chronic dermal wounds |
Company enrolled the first patients in clinical trials (4/18) |
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SangStat Medical Corp. (SANG) |
RDP58 |
Anti-inflammatory peptide designed to inhibit the synthesis of TNF-alpha, gamma interferon and interleukin-12 |
Ulcerative colitis |
Phase II data showed a peak response rate of 77% and a 71% remission rate - both statistically significant (4/9) |
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Sucampo Pharmaceuticals |
SPI-0211 |
A chloride channel activator |
Constipation- predominant irritable bowel syndrome |
Company began a clinical study (4/28) |
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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; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; OSE = Oslo Stock Exchange; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange |