| Company* | Product | Description | Indication | Status (Date) |
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| AltaRex Corp. | OvaRex | Modified murine monoclonal antibody that binds to CA125 cancer antigen | Ovarian cancer | Company completed a 345-patient pivotal trial; data still need to be evaluated (9/4) |
| Atrix | Leuprogel Three-Month Depot | Atrigel formulation containing leuprolide acetate; injected subcutaneously | Prostate cancer | Phase III data showed Leuprogel achieved testosterone levels below the generally accepted level (9/20) |
| Biomira USA | ¿ | Vaccine; a liposomal formulation containing a patient-specific cancer antigen, as well as interleukin-2 | B-cell lymphoma | Company initiated a Phase Ib trial (9/10) |
| Cell Pathways | Aptosyn and Taxotere | Exisulind and weekly docetaxel | Solid tumors | Company completed a Phase I safety study showing the combination therapy is well tolerated (9/6) |
| Dendreon | Provenge | Vaccine that appears to delay tumor progression | Advanced hormone-resistant prostate cancer | Company completed patient enrollment in a Phase III trial (9/6) |
| Human | Repifermin | Keratinocyte growth factor-2 (KGF-2) | Mucositis in patients undergoing chemotherapy for multiple myeloma | Company initiated a Phase II trial (9/4); enrollment completed in a Phase IIa trial (9/24) |
| Inex Pharma- | Onco TCS | Therapeutic consisting of vincristine encapsulated in Inex's transmembrane carrier systems drug delivery technology | Non-Hodgkin's lymphoma | The clinical program expanded to include two pilot Phase II trials evaluating it with the approved drug Rituxan (9/5) |
| MGI Pharma | Irofulven | Anticancer compound | Advanced cancer | Company initiated a Phase I trial of irofulven in combination with Taxotere (docetaxel) (9/25) |
| ProlX Pharma | PX-12 | A thioredoxin inhibitor; small-molecule designed to block the growth of cancers | Advanced metastatic cancer | Company enrolled the first patient in a Phase I trial (9/25) |
| Ribozyme | Angiozyme | Antiangiogenic; ribozyme that targets the high-affinity receptor for vascular endothelial growth factor | Cancer | A third trial began evaluating Angiozyme in patients taking the standard combination chemotherapy regimen of carboplatin and paclitaxel (9/25) |
| Vical Inc. | Allovectin-7 | DNA lipid complex containing the human gene encoding the HLA-B7 antigen | Chemotherapy-naive patients with metastatic melanoma | Company completed enrollment of 200 patients in a Phase III trial (9/19) |
| Wilex AG | WX-UK1 | Small-molecule anti-metastatic drug | Cancer | Company began a Phase I study (9/25) |
CARDIOVASCULAR | ||||
| D-Pharm | DP-b99 | A neuroprotective agent that was shown to reduce brain infarct volumes and to help in recovery of neurological function | Acute stroke | Company began enrolling patients in a new Phase II study (9/11) |
| Human | Mirostipen | Myeloid progenitor inhibitory factor | Chemotherapy-induced neutropenia and thrombocytopenia | Company completed patient enrollment in two Phase II trials (9/20) |
| Pharma- | Antrin | Motexafin lutetium injection | Coronary artery disease | Company said Phase I results of photoangioplasty with Antrin indicated the treatment is feasible and well tolerated (9/4) |
CENTRAL NERVOUS SYSTEM | ||||
| Adolor Corp. | ADL 10- | Kappa agonist | Inflammatory pain | Company dosed the first group of volunteers in a Phase I trial (9/6) |
| Biogen Inc. | Antegren | An alpha-4 integrin inhibitor | Multiple sclerosis | Phase II results were positive (9/17) |
| Durect Corp. | Chronogesic | A three-month continuous infusion subcutaneous implant | Chronic pain | Phase II results showed patients had better pain control and a reduction of opioid side effects (9/5) |
| MitoKor* | ABP-150 | Non-feminizing estrogen that is believed to affect mitochondrial metabolic pathways | Parkinson's disease | Company completed a Phase I study (9/11) |
| NeoThera- | Neotrofin | Nerve regeneration drug | Alzheimer's disease | Company completed enrollment of 521 patients in a pivotal study (9/5) |
| Vertex | VX-745 | Oral p38 MAP kinase inhibitor | Rheumatoid arthritis | Company suspended Phase II development due to high-dose effects in animals (9/24) |
DIABETES | ||||
| AeroGen | Aerodose | Ipratropium inhaler; uses AeroGen's aerosol generator technology to aerosolize liquids | Type II diabetes | Phase II results indicated the amount of insulin absorbed into the body via inhalation is as consistent, from dose to dose, as that following subcutaneous injection (9/18) |
| Amylin | AC2993 | Synthetic exendin-4 | Diabetes | Phase II results were positive, showing all three doses stimulated insulin secretion and lowered fasting plasma glucose (9/19) |
| Emishpere | ¿ |
Two drug delivery agents for the oral delivery of insulin | Diabetes | Phase I data demonstrated absorption from the gastrointestinal tract with oral formulations of insulin, as well as reductions in blood glucose levels (9/7) |
| Generex | Oralin | Oral insulin spray delivered to the buccal cavity via Generex's RapidMist device | Type I and II diabetes | Data showed the spray may be a safe and effective replacement for injected insulin (9/24) |
| Restoragen | Betatropin | Recombinant glucagon-like peptide-1 | Type II diabetes | Phase II results demonstrated improvement of blood glucose levels in Type II diabetics treated with the drug for seven days (9/11) |
INFECTION |
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| Acambis plc | ChimeriVax- | Vaccine; inactivated, purified, whole virus recognizable to the immune system as JE virus | Japanese encephalitis | Company completed a Phase II trial (9/21) |
| BioMarin | Enzyme replacement therapy | Recombinant human N-acetylgalactosamine 4-sulfatase | Mucopolysaccharidosis VI | The therapy was well tolerated at both dose levels in a Phase I trial (9/6) |
| Cubist | Cidecin | Daptomycin for injection | Community-acquired pneumonia | Company completed patient enrollment in the first of two pivotal Phase III trials (9/6) |
| Gilead | Adefovir dipivoxil | Reverse transcriptase inhibitor | Hepatitis B | Pilot study results showed reduced hepatitis B virus in DNA at 48 weeks; the study was conducted in patients who also were infected with HIV (9/4); Phase III results showed improvements in liver histology at 48 weeks (9/19) |
| Origenix | ORI-1001 | Topical gel | Genital warts caused by human papillomavirus | Company began a Phase I study (9/6) |
MISCELLANEOUS | ||||
| Aastrom | SC-1 | Bone marrow cell | Patients undergoing stem cell transplantation | Clinical results showed combining SC-1 bone marrow stem cells with sub-therapeutic doses of PBSC resulted in hematopoietic recovery rates similar to those reported in patients receiving much higher doses of PBSC (9/28) |
| BioSpecifics | Cordase | Injectable collagenase treatment | Dupuytren's disease | Company concluded a Phase II trial (9/11) |
| Discovery | Surfaxin | Humanized, synthesized, peptide-containing surfactant | Idiopathic respiratory distress syndrome | Company initiated patient enrollment in a second Phase III trial (9/21) |
| Entropin | Esterom | Topical medicinal preparation | Impaired physical function due to soft-tissue injuries and diseases | Company treated the first person in a Phase II/III trial (9/25) |
| GenStar | Maximum | Factor VIII gene therapy | Hemophilia A | Company resumed enrollment in a Phase I trial, which was suspended due to adverse effects of transient blood coagulation and laboratory liver test abnormalities (9/25) |
| Inflazyme | IPL550,260 and IPL512,602 | Oral, anti-inflammatory compounds | Inflammation | Company received approval to begin two Phase I trials (9/24) |
| Inspire | INS365 | Ophthalmic eye drops | Dry eye syndrome | Company completed patient enrollment in two Phase III trials (9/18) |
| Interneuron | Trospium | Trospium chloride | Ovaractive bladder and urinary incontinence | Company initiated a Phase III trial (9/6) |
| Karo Bio | ¿ |
Compound that maintains the thyroid hormone's stimulatory effects on metabolism without the cardiac side effects | Obesity | Companies initiated Phase I trials (9/25) |
| MacroChem | Topiglan | Topical drug; 1% alprostadil and 5% Sepatopical formulation | Erectile dysfunction | Company did not hit all its endpoints in a Phase III trial; it achieved statistical significance with men achieving erection, but did not meet the endpoint of maintaining an erection through completion of intercourse (9/6) |
| MedImmune | MEDI-507 | Siplizumab; humanized monoclonal antibody | Psoriasis | Company started dosing patients in a Phase II trial (9/17); drug was well tolerated and improved psoriatic disease in initial trials (9/24) |
| Neurogen | NGD | A small-molecule C5a receptor antagonist | Inflammatory disorders | Company began Phase I testing (9/24) |
| NexMed | Alprox-TD | Cream that combines alprostadil and NexACT transdermal delivery technology | Erectile dysfunction | Company plans to begin two Phase III trials (9/19) |
| Oxford | OGT 918 (Vevesca) | Oral capsule formulation of a glucosyltransferase inhibitors | Type I Gaucher disease | Clinical results showed progressive improvements at 24 months (9/24) |
| PPL Thera- | tgBSSL | Transgenically produced Bile Salt Stimulated Lipase | Cystic fibrosis | Phase II trial results were positive showing improved fat absorption (9/6) |
| Regeneron | Axokine | Genetically re-engineered version of a naturally occurring human protein known as ciliary neurotrophic factor | Obesity | Phase II results showed that patients treated with the drug for 12 weeks maintained weight loss for at least 36 weeks, whereas placebo patients gained weight; the company initiated a Phase III program (9/11) |
| Select | TranStem system | The system acts by expanding the autologous stem cells for transplantation | Transplants | The joint venture opened an investigational new drug application for a Phase I/II study (9/21) |
| Sepracor | ¿ |
(R,R)-formoterol inhalation solution | Bronchospasm in patients with obstructive airways disease | Sepracor moved the product into Phase III studies (9/19) |
| Stressgen | HspE7 | Immunotherapeutic; recombinant fusion product composed of heat shock protein 65 from Mycobacterium bovis BCG and the protein E7 | Anal dysplasia | Phase II data showed that 71% of 56 patients were able to downgrade to low-grade dysplasia from high-grade dysplasia (9/4) |
| Vasogen | ¿ |
Immune modulation therapy | Psoriasis | Company said it reached full enrollment in a multicenter clinical trial (9/26) |
| Xenova | TA-NIC | Vaccine that seeks to prevent nicotine from entering the brain | Nicotine addiction | Company entered Phase I trials (9/10) |
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| Notes: |
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| * Privately held |
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| Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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| AMEX = American Stock Exchange; LSE = London Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange |
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| NDA = New Drug Application |
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