Company* (Country; Symbol) | Product |
Description | Indication |
Status (Date) |
AUTOIMMUNE | ||||
Abbott Laboratories |
Humira (FDA-approved) to block TNF-alpha |
Adalimumab; fully |
Crohn's disease |
Presented Phase III data showing a statistically significant increase in remission at four weeks in CLASSIC trial in 229 patients; also, open-label trial in 29 hard- to-treat patients also showed clinical benefit (5/18) |
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Abbott Laboratories |
Humira (FDA- approved) |
Adalimumab; fully |
Rheumatoid arthritis |
Published 52-week data show drug with methotrexate resulted in significantly less structural joint damage and improved physical function (5/10) |
| ||||
Androclus Therapeutics* |
AT-001 (dnaJP1) |
Short, engineered oral |
Rheumatoid arthritis |
Published Phase I/II data showed no side effects and a change from pro-inflammatory to regulatory T-cell function (5/14) |
| ||||
Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland) |
Antegren (natalizumab) |
Humanized |
Crohn's disease |
Phase III trial in 339 patients who responded to the drug in ENACT-1 showed they maintained clinical response and remission rates through six months at a statistically significant rate; also said European filing planned for 4Q:04 (5/18) |
| ||||
Centocor Inc. (unit of Johnson & Johnson) and Schering-Plough Corp. |
Remicade (FDA- approved) |
Infliximab; |
Crohn's disease |
Began SONIC trial comparing drug to the immunosuppressant azathioprine, alone and vs. the combination of both drugs; the primary endpoint is steroid-free remission (5/17) |
| ||||
Immunomedics Inc. (IMMU) |
Epratuzumab |
Humanized |
Lupus |
Intitial Phase II results on 11 patients demonstrated no adverse events and early evidence of symptomatic improvement (5/11) |
| ||||
Incyte Corp. (INCY) |
INCB3284 |
Oral CCR2 |
Rheumatoid arthritis |
Began Phase I trial to assess safety and tolerability in healthy volunteers (5/11) |
| ||||
Protein Design Labs Inc. (PDLI) |
Daclizumab (FDA-approved as Zenapax) |
Humanized |
Ulcerative colitis |
Phase II trial failed to meet its primary endpoint of patients achieving remission at week eight at either of two doses (5/16) |
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CANCER | ||||
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Adventrx Pharmaceuticals Inc. (AMEX:ANX) |
CoFactor |
Biomodulator of 5- |
Metastatic colorectal cancer |
Began Phase II trial to evaluate the drug in untreated patients or those who have relapsed from 5-FU/leucovorin therapy (5/4) |
| ||||
Aphton Corp. (APHT) |
G17DT |
Immunotherapy |
Gastric carcinoma |
Published Phase II data showed G17DT immunization was capable of raising functional antibodies to gastrin 17 (5/27) |
| ||||
Bioenvision Inc. (AMEX:BIV) |
Clofarabine |
Second-generation |
Acute myeloid leukemia |
Phase II trial is ending early after exceeding expectations, to expedite start of pivotal trial; nine of 14 older patients in study experienced a complete response from single-agent therapy (5/19) |
| ||||
Bioniche Life Sciences Inc. (Canada; TSE: BNC) |
MCC |
Mycobacterial cell- |
Superficial bladder cancer |
Phase I/II trial in 55 patients produced complete responses of 43% to 64%, depending on the dose (5/20) |
| ||||
Callisto Pharmaceuticals Inc. (OTC BB:CLSP) |
Atiprimod |
Drug designed to |
Relapsed multiple myeloma |
Began Phase I/II trial in up to 40 patients to assess dosing, pharmacokinetics and responses (5/26) |
| ||||
Cell Therapeutics Inc. (CTIC) |
Trisenox (FDA-approved) |
Arsenic trioxide |
Multiple myeloma |
Published Phase II data showed responses were achieved in 33% of 24 patients tested; six patients achieved stable disease (5/19) |
| ||||
Cell Therapeutics Inc. (CTIC) |
Trisenox (FDA-approved) |
Arsenic trioxide |
Myelodysplatic syndrome
|
Published Phase II data showed drug with thalidomide produced multilineage hematologic responses in 25% of 28 patients (5/19) |
| ||||
CIMA Labs Inc. (CIMA) |
OraVescent Fentanyl |
Fentanyl formulated |
Breakthrough cancer pain |
Began Phase III trial; details were not disclosed (5/6) |
| ||||
Cytogen Corp. (CYTO) |
Quadramet |
Samarium-153 |
Pain from prostate cancer that has spread to the bone |
Published data from 152-patient trial demonstrated statistical significance for pain relief and a decrease in opioid use (5/10) |
| ||||
Cytokinetics Inc. (CYTK) and GlaxoSmithKline plc (UK) |
SB-743921 |
Small-molecule |
Solid tumors |
Began Phase I trial to assess dosing, safety, tolerability and pharmacokinetics in patients with advanced cancers (5/13) |
| ||||
Epeius Biotechnologies Corp.* |
Rexin-G |
Tumor-targeted, |
Metastatic cancer |
Patient treated in the Philippines experienced tumor shrinkage; the FDA has OK'd Phase I/II trial in in the U.S. (5/13) |
| ||||
GenVec Inc. (GNVC) |
TNFerade |
Adenovector with |
Pancreatic and esophageal cancers |
Update on 37 patients in Phase II pancreatic trial showed a dose-related improvement in local tumor control; early data from Phase II esophageal trial showed indications of activity (5/17) |
| ||||
GlobeImmune Inc.* |
GI-4000 series |
Immunotherapy |
Cancers |
Beginning Phase I trials in 15 to 25 patients with solid tumors to evaluate safety, immunogenicity and clinical benefit (5/25) |
| ||||
GlycoGenesys Inc. (GLGS) |
GCS-100LE |
Ethanol-free |
Solid tumors |
Began Phase I trial to assess safety, pharmacokinetics and dosing in up to 30 patients (5/12) |
| ||||
Hybridon Inc. (AMEX:HBY) |
IMOxine (HYB2055) |
Immunomodulatory oligo-nucleotide; |
Cancers |
Company is extending Phase I trial after initial data showed product was safe and produced immunological activity in patients with metastatic disease (5/10) |
| ||||
Lorus Therapeutics Inc. (Canada; TSE:LOR) |
GTI-2040 |
Targets the R2 |
Unresectable colon cancer |
Began trial in combination with oxaliplatin and capecitabine to assess dosing and pharmacody- namic effects on cellular markers (5/4) |
| ||||
Maxim Pharmaceuticals Inc. (MAXM) |
Ceplene |
Histamine |
Acute myeloid leukemia |
Phase III trial in 320 patients with AML in complete remission showed a statistically significant increase in leukemia-free survival (5/12) |
| ||||
Millennium Pharmaceuticals Inc. (MLNM) |
Velcade (FDA-approved) |
Bortezomib; |
Indolent non- Hodgkin's lymphoma |
Final Phase III analysis showed Velcade produced a statistically significant survival benefit vs. high-dose dexamethasone; monitors had stopped the trial early after seeing the benefit (5/17) |
| ||||
Millennium Pharmaceuticals Inc. (MLNM) |
Velcade (FDA-approved) |
Bortezomib; |
Indolent non- Hodgkin's lymphoma |
Began Phase II trial in combination with rituximab to assess efficacy, safety and tolerability in up to 66 relapsed or refractory patients (5/13) |
| ||||
NeoPharm Inc. (NEOL) |
IL13-PE38QQR |
Tumor-targeting agent designed to deliver bacterial cytotoxic PE38 |
Glioblastoma multiforme |
Presented additional Phase I/II data that support company's Phase III Precise trial (5/6) |
| ||||
Novogen Ltd. (NVGN) |
NV-18 |
Agent derived from company's phenoxodiol, which is designed to induce apoptosis |
Solid tumors |
Began Phase I trial to test three delivery methods in six patients (5/12) |
| ||||
OxiGene Inc. (OXGN) |
Combretastatin A4 Prodrug |
Vascular-targeting |
Cancers |
UK investigator reported anti- tumor activity and no unexpected toxicity in Phase I trial (5/17); interim data from three combination Phase I/II trials in solid tumors showed positive trends (5/17) |
| ||||
Salmedix Inc.* |
SDX-105 |
Bendamustine HCl; alkylating agent |
Non-Hodgkin's lymphoma |
Began Phase II trial, in combination with Rituxan, in 60 patients with relapsed, indolent or slowly progressing disease who are not refractory to Rituxan (5/4) |
| ||||
SuperGen Inc. (SUPG) |
Nipent (FDA-approved) |
Pentostatin for |
Hematopoietic stem cell transplantation |
Published data from study in 55 patients showed regimen with extracorporeal photopheresis, pentostatin and reduced-dose total-body irradiation showed evidence of reducing graft-vs.-host disease (5/21) |
| ||||
Tibotec Therapeutics (unit of Ortho Biotech Products LP) |
Doxil (FDA-approved) |
Liposomal |
Metastatic breast cancer |
Published Phase III trial in 539 patients showed comparable survival vs. doxorubicin with less cardiotoxicity (5/20) |
| ||||
Titan Pharmaceuticals Inc. (AMEX:TTP) |
Pivanex |
Agent designed to inhibit histone deacetylases class of enzymes |
Chronic lymphocytic leukemia and refractory malignant melanoma |
Began Phase II trial in each indication to assess the preliminary safety and efficacy of single-agent administation (5/24) |
| ||||
Vion Pharmaceuticals Inc. (VION) |
Triapine |
Inhibitor of ribonucleotide reductase (inhibits a step in DNA |
Cancers |
Published Phase I data showed drug could be administered on an every-other-week schedule with tolerable and reversible toxicity (5/6) |
| ||||
Vion Pharmaceuticals Inc. (VION) |
Cloretazine (VNP40101M) |
Sulfonyl hydrazine DNA alkylating agent |
Refractory leukemia |
Published Phase I data established maximum tolerated dose and single-agent activity was seen (5/6) |
| ||||
Wilex AG* (Germany) |
WX-UK1 |
Noncytotoxic small molecule designed to inhibit the urokinase plasminogen-activator system |
Solid tumors |
Began Phase I trial to evaluate safety and activity in combination with capecitabine in up to 54 patients with advanced solid tumors (5/25) |
| ||||
Wilex AG* (Germany) |
Rencarex (WX-G250) |
Chimeric monoclonal IgG1 antibody that binds to the MN cell- surface antigen |
Renal-cell carcinoma |
Got FDA OK for pivotal Phase III trial as an adjuvant therapy in patients at high risk of recurrence after resection of the primary tumor (5/10) |
| ||||
Xanthus Life Sciences Inc.* |
Xanafide (amonafide) |
A new salt formulation of the cancer compound amonafide |
Metastatic prostate cancer |
Began Phase I/II study in 40 hormone-refractory patients to define and validate the safety of a phenotypically driven dosing regimen, as well as efficacy (5/25) |
| ||||
YM BioSciences Inc. (Canada; TSE:YM) |
TheraCIM hR3 |
Humanized anti- epidermal growth |
Head and neck cancer |
Published data showed the drug was well tolerated and may enhance radiation-induced tumor responses (5/12) |
| ||||
CARDIOVASCULAR | ||||
| ||||
Alteon Inc. (AMEX:ALT) |
ALT-711 |
Alagebrium chloride; A.G.E. crosslink breaker |
Hypertension |
Post hoc analysis of Phase IIb SAPPHIRE/SILVER trials showed a significant reduction in systolic blood pressure in difficult-to-treat patients (5/19) |
| ||||
Avigen Inc. (AVGN) |
Coagulin-B |
Adeno-associated |
Hemophilia B |
Stopped Phase I trial after mild liver toxicity was observed coincident with doses in which Factor IX expression decreases (5/27) |
| ||||
BioSurface Engineering Technologies Inc.* |
HepaSil |
Chemically modified heparin designed for controlled release from medical devices |
Vascular grafts |
Published data showed the product improved acute and subacute patency of small-bore synthetic vascular grafts (5/12) |
| ||||
Cardiome Pharma Corp. (Canada; TSE:COM) |
RSD1235 |
Intravenous agent designed to selectively block ion channels in the heart |
Atrial fibrillation and atrial flutter |
Monitoring board found no safety issues and recommended Phase III ACT I trial continue (5/7) |
| ||||
Cerus Corp. (CERS) |
Intercept Blood System |
Pathogen-inactivation system for red blood cells that uses the compound S-303 |
Blood transfusions |
Phase IIIc trial in 35 patients with thrombotic thrombocytopenic purpura met its primary and secondary endpoints vs. control plasma (5/19) |
| ||||
Corgentech Inc. (CGTK) and Bristol-Meyers Squibb Co. |
E2F Decoy (edifoligide) |
Oligonucleotide designed to inactivate the cell-cycle transcription factor |
Arterio-venous graft failure |
Began Phase I/II trial in 60 patients with end-stage renal disease who require hemodialysis (5/18) |
| ||||
Encysive Pharmaceuticals Inc. (ENCY) |
Thelin (sitaxsentan) |
Small molecule designed to block endothelin |
Pulmonary arterial hypertension |
New data from pivotal Phase IIb/III STRIDE-1 trial support use in earlier-stage patients and showed benefit after one year (5/24) |
| ||||
Inflazyme Pharmaceuticals Ltd. (Canada; TSE:IZP) |
GH9001 |
Medium-molecular-weight heparin combined with low-molecular-weight dermatan sulfate |
Prevention of blood clotting |
Company dropped development after Phase Ib trial showed elevated liver enzymes in those given repeated doses (5/13) |
| ||||
Myogen Inc. (MYOG) |
Ambrisentan |
Type-A selective endothelin receptor antagonist |
Pulmonary aterial hypertension |
Presented Phase II data showing a statistically significant increase in the primary endpoint, six- minute walk distance, in all dose groups evaluated (5/24) |
| ||||
Nuvelo Inc. (NUVO) |
rNAPc2 |
Recombinant |
Acute coronary syndromes |
Reinitiated Phase IIa ANTHEM/ TIMI 32 trial; will enroll another 98 patients to bring total to 175; Nuvelo licensed the drug from Dendreon Corp. in February (5/13) |
| ||||
TransTech Pharma Inc.* |
TTP889 |
Small-molecule |
Thromboembolic disorders |
Completed Phase I trial and said Phase II will begin in September (5/10) |
| ||||
CENTRAL NERVOUS SYSTEM | ||||
| ||||
Axonyx Inc. (AXYX) |
Phenserine |
Inhibitor of acetylcholin-esterase and beta-amyloid precursor protein |
Alzheimer's disease |
Blinded review of Phase IIb trial confirmed the original power requirements and the ability of the study to achieve its objectives (5/6) |
| ||||
Boston Life Sciences Inc. (BSLI) |
Altropane |
Molecular targeting radioimaging agent |
Parkinson's disease diagnosis |
Began Phase III trial in 500 subjects to test differentiation of Parkinsonian and non-Parkinsonian tremors (5/20) |
| ||||
Corcept Therapeutics Inc. (CORT) |
Corlux (mifepristone) |
Oral GR-II antagonist with potential mitigating effects on cortisol |
Psychotic major depression |
Corcept '03 trial with 221 patients demonstrated statistical significance in reducing the psychotic features (5/3) |
| ||||
Endo Pharmaceuticals Inc. (ENDP) and SkyePharma plc (UK; SKYE) |
DepoMorphine |
Sustained-release, injectable, liposomal formulation of |
Post-operative pain |
Presented data from four studies that demonstrated product may be an effective and convenient option for managing pain (5/7) |
| ||||
Guilford Pharmaceuticals Inc. (GLFD) |
Aquavan Injection |
Water-soluble prodrug of propofol |
Sedation |
Began Phase III program to test the product in those undergoing procedures that require mild to moderate sedation (5/10) |
| ||||
Incara Pharmaceuticals Corp. (OTC BB:ICRA) |
AEOL 10150 |
Catalytic antioxidant compound |
Amyotrophic lateral sclerosis |
Filed IND for Phase I trial to test the product in healthy volunteers (5/5) |
| ||||
Neurochem Inc. (Canada; NRMX) |
Alzhemed |
Small molecule designed to interfere with association between glycosaminoglycans |
Alzheimer's disease |
Starting 18-month Phase III trial in about 950 patients with mild to moderate disease; a similar trial is planned for Europe (5/19) |
| ||||
Neurocrine Biosciences Inc. (NBIX) |
Indiplon |
Immediate-and modified-release formulations of a non-enzodiazapine agent that targets GABA-A receptor |
Insomnia |
Presented data from various studies showing effectiveness of he drug across different patient populations; Phase I trial showed modified-release does not effect respiratory function (5/6) |
| ||||
Neurocrine Biosciences Inc. (NBIX) |
Indiplon |
Immediate-release formulation of non- benzodiazapine agent that acts on a specific site of the GABA-A receptor |
Insomnia |
Study in healthy volunteers demonstrated drug taken in the middle of the night was safe and well tolerated without next-day residual effects (5/4) |
| ||||
NeurogesX Inc.* |
NGX-4010 |
Trans-capsaicin |
Post-herpetic neuralgia |
Phase II trial showed a 33% reduction in pain scores over four weeks vs. 4% for control (5/14) |
| ||||
Orphan Medical Inc. (ORPH) |
Xyrem (FDA-approved) |
Sodium oxybate oral solution |
Narcolepsy |
Phase IIIb SXB-15 trial in 228 patients met endpoints of improving excessive daytime sleepiness (5/19) |
| ||||
Phase 2 Discovery Inc.* |
PD-6735 |
Melatonin analogue; agonist at melatonin-1 and melatonin-2 receptors |
Insomnia |
Phase II trial in 40 patients produced statistically significant improvements in sleep latency (5/20) |
| ||||
Phase 2 Discovery Inc.* |
PD-6735 |
Melatonin analogue; agonist at melatonin-1 and melatonin-2 receptors |
Sleep disorders |
Phase I trial showed all doses were well tolerated without increased adverse events (5/20) |
| ||||
Pozen Inc. (POZN) and Glaxo-SmithKline plc (UK) |
Trexima (MT 400) |
Single-tablet combination of sumatriptan (5- T1B/1D agonist) and naproxen sodium |
Migraine |
Began Phase III program that will consist of two pivotal trials and a long-term safety study (5/18) |
| ||||
Progenics Pharmaceuticals Inc. (PGNX) |
Methylnaltrexone (MNTX) |
Agent designed to block peripheral |
Chronic pain in opioid-induced constipation |
Completed Phase I trial in 61 healthy volunteers showing drug was well tolerated and exhibited predictabl epharmacokinetics (5/25) |
| ||||
Saegis Pharmaceuticals Inc.* |
SGS742 |
Selective, orally |
Alzheimer's disease |
Began Phase II trial to evaluate safety and efficacy of drug in patients with mild to moderate disease (5/3) |
| ||||
Sepracor Inc. (SEPR) |
Estorra |
Eszopiclone tablets |
Insomnia |
Presented data from multiple trials in different patient popu- lations; an approvable letter has been issued for the drug (5/6) |
| ||||
DIABETES | ||||
| ||||
ConjuChem Inc. (Canada; TSE:CJC) |
DAC:GLP-1 |
Insulinotropic |
Type II diabetes |
Began Phase II trial in combination with Metformin to assess HbA1C levels vs. control (5/26) |
| ||||
Generex Biotechnology Corp. (GNBT) |
Oralin |
Oral insulin spray formulation |
Type I diabetes |
Company completed dose- finding study in advance of a Phase IIb trial (5/3) |
| ||||
INFECTION | ||||
| ||||
Anadys Pharmaceuticals Inc. (ANDS) |
ANA380 (LB80380) |
Nucleoside analogue |
Hepatitis B |
Phase I/IIa trial in 28 patients showed the product was safe and reduced viral load (5/11) |
| ||||
Avant Immunotheraeutics Inc. (AVAN) |
LFn-p24 |
Anthrax-derived poly- peptide called lethal factor fused to the HIV-1 gag p24 protein |
HIV |
Phase I trial of the vaccine began to assess safety and immunogenicity in 18 healthy volunteers (5/13) |
| ||||
AVI BioPharma Inc. (AVII) |
AVI-4020 |
Neugene antisense |
West Nile virus |
Phase I/II trial in 10 patients showed the presence of the drug in cerebrospinal fluid; no safety issues were reported (5/4) |
| ||||
Chiron Corp. (CHIR) |
Tifacogin |
Recombinant form of tissue factor pathway inhibitor |
Severe community-acquired pneumonia |
Began Phase III CAPTIVATE trial in 1,200 patients worldwide with a primary endpoint of reduced mortality at 28 days (5/18) |
| ||||
Genzyme Corp. (GENZ) |
Tolevamer sodium |
Investigational |
Clostridium difficile-associated diarrhea |
300-patient Phase II trial showed tolevamer met the noninferiority endpoint with safety and efficacy similar to vancomycin (5/3) |
| ||||
Human Genome Sciences Inc. (HGSI) |
Albuferon |
Albumin interferon- alpha; long-acting form of interferon-alpha |
Hepatitis C |
Began a Phase II trial in Canada in 40 interferon-naive patients to assess safety, tolerability, pharmacology and dosing (5/26) |
| ||||
Idenix Pharmaceuticals Inc.* |
NM283 |
Antiviral agent |
Hepatitis C |
Phase I/II trial in 82 patients showed the drug was safe and produced dose-related reductions in serum HCV RNA (5/18) |
| ||||
InterMune Inc. (ITMN) |
Infergen (FDA- approved) |
Interferon alfacon-1 |
Hepatitis C |
Investigator-sponsored studies of combination therapy with ribavirin in nonresponders showed sustained virologic response rates of about 25% (5/17) |
| ||||
InterMune Inc. (ITMN) |
Infergen and Actimmune (both FDA-approved) |
Interferon alfacon-1 and interferon |
Hepatitis C |
Began Phase II trial in up to 80 nonresponding patients to test therapy with or without ribavirin; a goal is to see if Actimmune can replace ribavirin as an adjunct to Infergen in these patients (5/13); retrospective analysis showed 15 of 32 nonresponders had undetectable levels of HCV RNA in their blood (5/17) |
| ||||
MedImmune Inc. (MEDI) and Wyeth |
CAIV-T |
Intranasal, cold-adapted trivalent influenza vaccine; next generation of FluMist |
Influenza |
Phase III trials in infants and children showed better protection against flu than the traditional injectible flu vaccine (5/3) |
| ||||
Progenics Pharmaceuticals Inc. (PGNX) |
PRO 140 |
Humanized monoclonal antibody designed to block the CCR5 co- receptor |
HIV |
Began Phase I trial in healthy volunteers to evaluate tolerability and pharmacologic profile (5/4) |
| ||||
Rigel Pharmaceuticals Inc. (RIGL) |
R803 |
Small-molecule non- nucleoside HCV polymerase inhibitor |
Hepatitis C |
Began a Phase I/II trial to assess safety, tolerability and pharmacokinetics of multiple doses in HCV patients (5/24) |
| ||||
Samaritan Pharmaceuticals Inc. (OTC BB:SPHC) |
SP-01A |
Agent designed to decrease levels of the stress hormone |
HIV |
Phase I/II trial demonstrated positive safety profile and encour-aging efficacy data (5/6) |
| ||||
Tanox Inc. (TNOX) |
TNX-355 |
Humanized anti-CD4 monoclonal antibody |
HIV |
Began Phase II trial in 80 patients to evaluate safety and activity in combination with optimized background therapy as assessed by viral load reduction (5/5) |
| ||||
Theravance Inc.* |
Telavancin (TD-6424) |
Injectable antibiotic believed to have multiple mechanisms |
Infections |
Presented various data from Phase I trials that will help in later studies (5/11) |
| ||||
Vertex Pharmaceuticals Inc. (VRTX) |
Merimepodib (VX-497) |
Small-molecule |
Hepatitis C |
Began Phase II trial in 315 patients who will receive merimepodib or placebo with peginterferon and ribavirin (5/25) |
| ||||
Vicuron Pharmaceuticals Inc. (MICU) |
Dalbavancin |
Glycopeptide agent from the same class as vancomycin |
Catheter-related bloodstream infections |
Presented Phase II data showing superior efficacy of drug combined with vancomycin (5/4) |
| ||||
ViroPharma Inc. (VPHM) |
Pleconaril |
Intranasal form of antiviral designed to inhibit function of the picornavirus capsid |
Common cold |
Completed Phase I trial in 93 adult volunteers showing it was safe and well tolerated, and appeared to produce clinical benefit (5/25) |
| ||||
Zengen Inc.* |
CZEN-002 |
Non-azole antifungal synthetic octapeptide |
Vulvovaginal candidiasis |
Phase I/II trial in 17 patients showed signs of efficacy and that the product was safe and well tolerated (5/25) |
| ||||
MISCELLANEOUS | ||||
| ||||
Anika Therapeutics Inc. (ANIK) |
-- |
Hyaluronic acid-based cosmetic tissue augmentation therapy |
Nasolabial folds |
Began a pivotal trial in up to 200 patients that will compare the product to a dermal filler made from collagen (5/10) |
| ||||
Avanir Pharmaceuticals Inc. (AMEX:AVN) |
AVP 13358 |
Molecule designed to inhibit IgE production and suppress IL-4 and IL-5 responses |
Asthma/ allergy |
Phase I trial in 54 healthy volunteers showed drug was well tolerated at all doses and displayed positive availability in the blood- stream (5/3) |
| ||||
Barrier Therapeutics Inc. (BTRX) |
Sebazole |
Topical formulation of 2.0% ketoconazole, |
Seborrheic dermatitis |
Began Phase III trial to test the drug vs. placebo in 440 patients to measure clearance of the condition (5/26) |
| ||||
BioBalance Corp. (OTC BB:BBAL) |
Probactrix |
Strain of E. coli in a BioBalance |
Proximal inflammation of the small intestine |
Twelve of 18 patients in a clinical trial showed a clinical response of reduced abdominal symptoms (5/18) |
| ||||
ConjuChem Inc. (Canada; TSE:CJC) |
DAC:GFR1 |
Chemically modified form of growth-releasing factor bonds to albumin |
Growth homone deficiency in children |
Began Phase I study in up to 48 subjects to assess safety and tolerability, and to measure pharmacokinetic profiles (5/5) |
| ||||
DUSA Pharmaceuticals Inc. (DUSA) |
Levulan (FDA- approved) |
Photodynamic |
Facial photodamage |
Began Phase II trial that first will evaluate light dosages, then test efficacy vs. vehicle in 64 and 60 patients, respectively (5/20) |
| ||||
Eyetech Pharmaceuticals Inc. (EYET) and Pfizer Inc. |
Macugen |
Pegaptanib sodium; vascular endothelial growth factor inhibitor |
Diabetic maculare dema |
Preliminary data from Phase II trial were statistically significant vs. sham injection for increasing lines gained on visual chart (5/3) |
| ||||
FemmePharma Inc.* |
FP1096 |
Investigational drug delivered intravaginally |
Endometriosis |
Phase II trial in 30 patients showed a statistically significant improvement in symptoms of the disorder (5/5) |
| ||||
Genaera Corp. (GENR) |
Squalamine |
Anti-angiogenesis agent; VEGF inhibitor |
Wet age- related macular degeneration |
Began enrollment of 18 patients in Phase II trial to test pharmacokinetics and safety (5/4) |
| ||||
Genentech Inc. (NYSE:DNA), Tanox Inc. (TNOX) and Novartis AG (Switzerland) |
Xolair (FDA- approved) |
Omalizumab; humanized monoclonal antibody to IgE |
Asthma |
Began Phase III trial designed to enroll 570 patients between 6 and 12 years old, and assess safety and efficacy (5/17) |
| ||||
Genzyme Corp. (GENZ) |
Seprafilm (FDA- approved) |
Hyaluronic acid-based adhesion barrier |
Small-bowel obstruction |
A five-year study involving nearly 1,800 patients showed Seprafilm reduced the relative risk of a first adhesive obstruction (5/11) |
| ||||
Hemispherx Biopharma Inc. (AMEX: HEB) |
Ampligen |
RNA drug with potential action as an immuno-modulator and antiviral |
Chronic fatigue syndrome |
Pivotal Phase III trial vs. placebo met its primary endpoint in performance measured by a tread- mill test (p=0.022) (5/3) |
| ||||
Isolagen Inc. (AMEX:ILE) |
Isolagen Process |
Autologous cellular therapy |
Periodontal disease |
Phase I data showed growth of the papilla and bone deposition; company also said it was starting a Phase II trial (5/11) |
| ||||
Isotechnika Inc. (Canada; TSE:ISA) |
TAFA-93 |
Small-molecule |
Various conditions |
Began a Phase I trial at a single center in Canada that will include about 50 subjects (5/7) |
| ||||
Nastech Pharmaceutical Co. Inc. (NSTK) |
PYY3-36 Nasal Spray |
High-affinity Y2 receptor agonist |
Obesity |
Presented Phase I data showing agent was delivered effectively and produced no serious adverse events (5/26) |
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Nastech Pharmaceutical Co. Inc. (NSTK) |
PTH1-34 |
Intranasal |
Osteoporosis |
Began Phase I study to assess nasal absorption and safety (5/3) |
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OxiGene Inc. (OXGN) |
Combretastatin A4 Prodrug |
Vascular-targeting |
Wet age-related macular degeneration |
Data from seven patients in Phase I/II trial showed no serious adverse events and some evidence of clinical activity (5/17) |
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Palatin Technologies Inc. (AMEX:PTN) |
PT-141 |
Intranasally delivered melanocortin agonist |
Erectile dysfunction |
Presented Phase IIb data in 271 patients showing favorable safety and efficacy (5/10) |
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Santarus Inc. (SNTS) |
Rapinex |
Immediate-release formulation of the proton pump inhibitor omeprazole |
Prevention of upper gastrointestinal bleeding |
Presented data from Phase III trial that showed statistical signifance in the primary endpoint; approval filing has been made with FDA (5/19) |
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Sucampo Pharmaceuticals Inc.* |
SPI-0211 |
Chloride channel activator |
Constipation |
Withdrawal study duplicated the positive results of pivotal Phase III trial (5/11); 128-subject study showed agent caused no rebound effect; dosing was stopped (5/25) |
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Sucampo Pharmaceuticals Inc.* |
SPI-0211 |
Chloride channel activator |
Irritable bowel syndrome |
Phase II trial in 195 patients with constipation-predominant IBS (5/11) |
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Theratechnologies Inc. (Canada; TSE:TH) |
ThGRF |
Transdermal formulation of parathyroid hormone |
Osteoporosis |
Phase I study with ALZA Corp.'s Macroflux delivery technology demonstrated positive delivery, bioavailability, activity and safety (5/3) |
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; NYSE = New York Stock Exchange | ||||
