Company* |
Product | Description | Indication |
Status |
| | ||||
AUTOIMMUNE | ||||
Alba |
AT-1001 |
Oral zonulin receptor antagonist |
Celiac disease |
Began Phase I trial that will evaluate safety, tolerability and pharmacokinetics in 24 volunteers (9/27) |
| ||||
Arakis Ltd. |
AD 452 |
Small-molecule, disease- modifying anti-rheumatic agent |
Rheumatoid arthritis |
Began Phase IIb trial with methotrexate to evaluate efficacy and safety in 292 patients (9/5) |
| ||||
Chiron Corp. |
Betaseron (FDA-approved) |
Interferon beta-1b |
Multiple sclerosis |
Preliminary 16-year follow-up data showed advantages for the drug group vs. placebo (9/27); BENEFIT trial showed drug reduced the risk of developing clinically definite MS by 50% vs. placebo (9/30) |
| ||||
Genzyme |
Campath (FDA- pproved) |
Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces |
Multiple sclerosis |
One-year data from Phase II trial vs. Rebif showed advantage in the Campath arm, but dosing was stopped after three cases of severe idiopathic thrombocy- topenic purpura were seen (9/16) |
| ||||
Protalex Inc. |
PRTX-100 |
Bioregulatory compound designed to normalize the activity of immune cells |
Rheumatoid arthritis |
Starting Phase I trials following the FDA's lifting of a clinical hold on the product (9/13) |
| ||||
Synta |
STA-5326 |
Small-molecule, selective inhibitor of the IL-12 cytokine family |
Crohn's disease |
Began Phase IIb SCORE trial to evaluate safety and efficacy; a companion study will evaluate biological markers (9/14) |
| ||||
CANCER | ||||
AnorMED Inc. |
AMD3100 |
Agent designed to block receptor that triggers movement of stem cells out of bone marrow |
Stem cell transplantation in cancer |
Trial showed patients taking drug plus G- SF were able to collect more stem cells than those taking G-CSF alone (9/6) |
| ||||
Allos |
Efaproxyn |
Efaproxiral; small molecule designed to sensitize hypoxic areas of tumors during radiation therapy |
Unresectable non-small-cell lung cancer |
Phase II trial in 51 patients suggest adding drug to sequential chemoradiotherapy may improve survival over S-CRT alone without increasing radiation toxicity (9/1) |
| ||||
Antisoma plc |
AS1411 |
Anti-nucleolin aptamer |
Cancers |
The company re-opened a Phase I trial in patients with renal and non-small-cell lung cancers (9/6) |
| ||||
A.P. Pharma |
APF530 |
The anti-emetic granisetron in a polymer-based drug delivery system |
Chemotherapy- induced nausea and vomiting |
Phase II trial in 45 patients met safety, pharmacokinetic and tolerability endpoints; evidence of efficacy was seen (9/29) |
| ||||
Avalon |
AVN944 |
Small-molecule inhibitor of the enzyme inosine monophosphate dehydroenase |
Advanced hematological malignancies |
Got OK to start Phase I trial in patients (9/30) |
| ||||
Cell |
Xyotax |
Paclitaxel linked to a biodegradable polyglutamate polymer |
Advanced non-small-cell lung cancer |
Data from PGT202 trial and from pooled data showed statistically significant survival advantage for women vs. men (9/27) |
| ||||
ChemGenex |
Quinamed |
Naphthalimide analogue; topoisomerase II inhibitor |
Cancers |
Phase II trial in prostate cancer was expanded to include patients with breast and ovarian cancers (9/26) |
| ||||
CuraGen Corp. |
PXD101 |
Small-molecule histone deacetylase inhibitor |
Advanced colorectal cancer |
Began Phase Ib trial to establish the maximum dose with 5-FU in up to 15 patients; then up to 20 patients with advanced colorectal cancer will be tested(9/27) |
| ||||
CuraGen Corp. |
PXD101 |
Small-molecule histone deacetylase inhibitor |
Advanced solid tumors |
Began Phase Ib trial to establish the maximum dose with carbo-platin and/or paclitaxel in up to 30 patients; afterward, 15 ovarian cancer patients will be added (9/13) |
| ||||
Cytheris SA* |
-- |
Recombinant interleukin- |
Myeloid |
Began Phase I trial in patients who underwent a T-cell-depleted allogenic hematopoietic cell transplant (9/19) |
| ||||
Cytokinetics |
Ispinesib |
Small-molecule inhibitor of kinesin spindle protein |
Advanced breast cancer |
Phase II trial will proceed after interim analysis demonstrated sufficient activity (9/27) |
| ||||
Cytokinetics |
Ispinesib (SB-715992) |
Small-molecule inhibitor of kinesin spindle protein |
Non-small-cell lung cancer |
Phase II trial did not demonstrate sufficient activity to proceed in platinum-refractory arm of Phase II trial (9/27) |
| ||||
EntreMed |
Panzem |
2-methoxyestradiol; naturally occurring metabolite of endogenous estrogen |
Refractory prostate cancer |
Phase II trial in 33 patients showed tolerability and reductions in PSA levels (9/27) |
| ||||
Exelixis Inc. |
XL844 |
Oral inhibitor of the protein kinases Chk 1 and 2 |
Chronic lymphocytic leukemia |
Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in patients (9/22) |
| ||||
Exelixis Inc. |
XL184 |
Agent believed to inhibit the hepatocyte growth factor receptor and VEGF-2 |
Advanced solid tumors |
Began Phase I trial to evaluate safety, tolerability and pharmaco- |
| ||||
Genentech Inc. |
Avastin (FDA-approved) |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Refractory ovarian cancer |
Stopped enrollment in Phase II trial due to a higher rate of gastrointestinal perforations reported than in previous trials (9/23) |
| ||||
Genentech Inc. |
Herceptin |
Trastuzumab; monoclonal antibody against HER2/neu protein |
Early stage breast cancer |
Interim data from Phase III trial with chemotherapy showed a significant reduction in disease recurrence in HER- positive early stage disease (9/13) |
| ||||
Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Relapsed/ refractory chronic lymphocytic leukemia |
Extended follow-up results from Phase III trial with chemotherapy showed significantly longer remission duration and significantly lower risk of relapse (9/19) |
| ||||
GlycoGenesys |
GCS-100 |
Complex carbohydrate agent |
Solid tumors |
Phase I trial established the maximum dose, demonstrated safety and tolerability and provided evidence of disease stability (9/8) |
| ||||
Greenwich |
SSG |
Sodium stibogluconate; targets a class of enzymes in cells |
Cancers |
Began Phase I trial to evaluate safety, tolerability, efficacy and dosing with interferon alpha-2b in 24 patients (9/13) |
| ||||
Hana |
IPdR |
Orally available thymidine analogue; prodrug of IUdR |
Cancers |
Began Phase I trial in patients to evaluate safety, dosing and preliminary efficacy in combination with radiation therapy (9/7) |
| ||||
IDM Pharma |
Uvidem |
Vaccine consisting of mature dendritic cells loaded with lysates of tumor cell lines |
Melanoma |
Began second stage of Phase II trial in 25 patients after first stage in 12 patients met response criteria (9/27) |
| ||||
ImmunoGen |
huN901-DM1 |
Antibody designed to deliver DM1 to CD56- expressing cancer cells |
Multiple myeloma |
Began Phase I trial to evaluate safety, dosing and anticancer activity (9/7) |
| ||||
Introgen |
INGN 225 |
Product using Advexin to stimulate dendritic cells, which are then used as a therapeutic vaccine |
Advanced small-cell lung cancer |
Interim data from ongoing Phase II trial showed vaccine was well tolerated and appeared to sensitize tumors to additional chemotherapy (9/12) |
| ||||
NeoPharm |
LEP-ETU |
Liposomal formulation of paclitaxel |
Cancers |
The product met study criteria in demonstrating bioequivalence to paclitaxel (Taxol) (9/29) |
| ||||
OncoGenex |
OGX-011 |
Second-generation anti- sense drug designed to inhibit the production of clusterin, a cell-survival protein |
Prostate cancer |
Phase I trial demonstrated tolerability and reduced clusterin expression (9/7) |
| ||||
Oncolytics |
Reolysin |
Formulation of the human reovirus |
Advanced solid tumors |
Began Phase I trial to evaluate dosing, safety and actvity in up to 36 patients (9/28) |
| ||||
OxiGene Inc. |
CA4P |
Combretastatin A4 prodrug; a vascular targeting agent |
Advanced ovarian cancer |
Began Phase II trial to evaluate the drug with carboplatin and paclitaxel in platinum- resistant disease (9/21) |
| ||||
rOxxon |
-- |
PrimeBoost immuno-therapeutic platform |
Metastatic melanoma |
Data from ongoing Phase II trial demonstrated safety, tolerability and immune responses (9/7) |
| ||||
Peplin Ltd. |
PEP005 Topical |
Agent designed to kill cancer cells and stimulate an immune response |
Actinic keratosis |
Began Phase IIa trial in 13 to 34 patients to determine the maximum tolerated dose (9/1) |
| ||||
Pharmacyclics |
Xcytrin |
Motexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosis |
Brain metastases from solid tumors |
Began Phase II trial to evaluate the drug with whole-brain radiation therapy and stereotactic radiosurgery in 45 patients(9/13) |
| ||||
Pharmacyclics |
Xcytrin |
Motexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosis |
Advanced non- small-cell lung cancer |
Began Phase II trial to evaluate safety and efficacy as a second- line treatment in 108 patients (9/8) |
| ||||
Point |
Talabostat |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
Advanced chronic lymphocytic leukemia |
Data from first 20 patients in Phase II trial with rituximab showed a 20% response rate, the rate needed to continue the trial(9/19) |
| ||||
Sonus |
Tocosol |
Formulation of paclitaxel |
Metastatic breast cancer |
Began pivotal trial under FDA SPA to evaluate response rate and other endpoints in 828 patients (9/28) |
| ||||
ViaCell Inc. |
CB001 |
Hematopoietic stem cells selectively amplified from umbilical cord blood |
Stem cell transplants in cancer applications |
Suspended enrollment in Phase I trial; 2 of 8 treated patients experienced Grade IV acute graft vs host disease (9/19); the FDA placed a hold on the trial (9/21) |
| ||||
Vion |
Cloretazine (VNP40101M) |
Sulfonylhydrazine DNA alkylating agent |
Advanced small-cell lung cancer |
Began Phase II trial to evaluate responses and toxicity in patients who did not respond to or relapsed after initial treatment (9/20) |
| ||||
Viventia |
Proxinium |
Antibody fragment conjugated with a cancer-killing payload |
Refractory head and neck cancer |
Starting a Phase II trial in the U.S. in patients with recurrent disease (9/19) |
| ||||
CARDIOVASCULAR | ||||
Amarillo |
-- |
Low-dose oral interferon alpha |
Bone marrow proliferative disorders |
Began trial to test product in 20 patients with either polycythemia vera or primary thrombocythemia (9/22) |
| ||||
Amgen |
Aranesp (FDA-approved) |
Darbepoetin alfa, a recombinant erythropoietic protein |
Heart failure |
Began Phase III trial to evaluate anemia treatment on morbidity and mortality in patients with heart failure (9/2) |
| ||||
Archemix Corp.* |
ARC183 |
Anti-thrombin aptamer |
Anticoagulant |
They ended development of the product after determining in a Phase I trial that it had a suboptimal dosing profile (9/21) |
| ||||
Cardiome |
RSD1235 |
Oral formulation of drug designed to selectively block ion channels in the heart |
Atrial arrhythmia |
Phase III ACT 3 trial in 276 patients achieved statistical significance vs. placebo in conversion to normal heart rhythm (9/29) |
| ||||
Cytokinetics |
CK-1827452 |
Small-molecule activator of cardiac myosin |
Heart failure |
Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in healthy volunteers (9/6) |
| ||||
Encysive |
Thelin |
Sitaxsentan; small molecule designed to block endothelin |
Pulmonary arterial hypertension |
Extension study from Phase III STRIDE 2 trial showed advantages vs. bosentan in some endpoints (9/14) |
| ||||
Isis |
ISIS 301012 |
Capsule formulation of second-generation anti- sense inhibitor of ApoB-100 |
Cholesterol management |
Began a Phase II trial that will evaluate dosing, safety and efficacy in patients with high cholesterol (9/20) |
| ||||
Microbia Inc.* |
MD-0727 |
Cholesterol absorption inhibitor |
High cholesterol |
Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in healthy volunteers (9/15) |
| ||||
NitroMed Inc. |
BiDil (FDA-approved) |
Nitric oxide-enhancing oral agent; combination of isosorbide dinitrate and hydralazine |
Heart failure in African-Americans |
Data from A-HeFT trial suggested drug can inhibit left ventricular remodeling in patients with severe heart failure (9/21) |
| ||||
Nuvelo Inc. |
Alfimeprase |
Modified fibrolase delivered via catheter; thrombolytic agent |
Central venous catheter occlusion |
Began Phase III SONOMA-2 trial to assess of catheter function vs. placebo in 300 patients (9/7) |
| ||||
Viron |
VT-111 |
Virally derived anti- inflammatory protein |
Acute coronary syndromes |
Began Phase II trial to evaluate safety and efficacy trends in 72 patients (9/26) |
| ||||
CENTRAL NERVOUS SYSTEM | ||||
Adolor Corp. |
-- |
Lidocaine patch |
Post-surgical incisional pain |
Began Phase II trial named Study 29CL227(9/15) |
| ||||
Aeolus |
AEOL 10150 |
Small-molecule catalytic antioxidant |
Amyotrophic lateral sclerosis |
Phase I trial in 25 patients showed tolerability and no drug-related cardiovascular abnormalities (9/6) |
| ||||
Axonyx |
Phenserine |
Inhibitor of acetylcholin- esterase and beta-amyloid precursor protein |
Alzheimer's disease |
Data from two curtailed Phase III trials did not demonstrate a statistically significant benefit vs. placebo (9/20) |
| ||||
Ceregene Inc.* |
CERE-120 |
Gene therapy product that delivers the neurturin gene via an adeno-associated virus Type II vector |
Parkinson's disease |
Began a Phase I trial that will evaluate safety and efficacy in PD patients (9/21) |
| ||||
Cypress Bioscience Inc. |
Milnacipran |
Norepinephrine serotonin reuptake inhibitors |
Fibromyalgia |
Pivotal Phase III trial in 888 patients failed to achieve statistical significance; the plan is to continue development (9/28) |
| ||||
CytRx Corp. |
Arimoclomol |
Small molecule designed to provide cellular protection by activating molecular chaperone proteins |
Amyotrophic lateral sclerosis |
Began Phase II trial to evaluate safety, tolerability and efficacy in 80 patients (9/22) |
| ||||
DOV |
DOV 216,303 |
Triple reuptake inhibitor |
Depression |
Both drug and citalopram groups showed improvements from baseline in Phase II trial in 67 patients (9/27) |
| ||||
DOV |
Bicifadine |
Serotonin and norepinephrine reuptake inhibitor |
Post-operative pain |
Phase III trial in 350 patients following bunionectomy surgery showed statistically significant analgesic effects at 400 mg vs. placebo (9/12) |
| ||||
Myriad |
Flurizan |
Selective amyloid beta 42 lowering agent |
Alzheimer's disease |
Follow-on data from Phase II trial showed patients appeared to have no further decline in cognitive function from months 12 to 15 (9/22) |
| ||||
Neurogen |
NG2-73 |
Selective modulator of gamma aminobutyric (GABA) receptors |
Insomnia |
Phase I trial in healthy volunteers showed the drug was safe and well tolerated and produced sleepiness (9/22) |
| ||||
Neurologix |
-- |
Adeno-associated virus delivering gene encoding glutamic acid decarboxylase |
Parkinson's disease |
Phase I trial in 12 patients showed a statistically significant (27%) improvement in motor function on the side of their body correlating to the treated part of the brain (9/26) |
| ||||
New River |
NRP290 |
Hydrocodone derivative |
Pain |
Pharmacokinetic trial in healthy volunteers demonstrated bio-availability (9/12) |
| ||||
Pain |
Remoxy |
Abuse-resistant form of long-acting oxycodone |
Chronic pain |
Phase III trial in 209 osteoarthritic patients showed a statistically significant improvement in pain relief vs. placebo (9/9) |
| ||||
Pharmos |
Cannabinor |
CB2-selective synthetic cannabinoid agent |
Pain |
Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in up to 48 healthy volunteers (9/6) |
| ||||
Proneuron |
ProCord |
Autologous incubated macrophage therapy |
Acute spinal cord injury |
Phase I trial in eight patients showed therapy was well tolerated; preliminary signs of efficacy were seen (9/12) |
| ||||
Sepracor |
Lunesta (FDA-approved) |
Eszopiclone tablets; a non-enzodiazepine agent |
Insomnia |
Phase IIIb/IV trial in 410 perimenopausal and menopausal women demonstrated statistical significance in various endpoints (9/30) |
| ||||
Sepracor |
Lunesta (FDA-approved) |
Eszopiclone tablets; a non-enzodiazepine agent |
Insomnia |
Six-month Phase IIIb/IV trial in 828 patients demonstrated statistical significance in various end-points (9/28) |
| ||||
Somaxon |
Silenor |
Low dose of the approved depression drug doxepin |
Insomnia |
Began a second Phase III trial, which will evaluate safety and efficacy in elderly patients (9/20) |
| ||||
DIABETES | ||||
Alkermes Inc. |
-- |
Inhaled insulin powder system based on Alkermes' AIR delivery technology |
Type I diabetes |
Phase II trial showed blood sugar levels similar to patients treated with injected insulin; 80% of patients preferred inhaled product vs. injected insulin (9/12) |
| ||||
CardioVascular |
Cardio Vascu-Grow |
Stimulator of angiogenesis |
Diabetic foot ulcers and wounds |
Starting a Phase I trial to test the safety and tolerability of the agent (9/13) |
| ||||
ConjuChem |
DAC:GLP-1 |
Insulinotropic hormone GLP created with firm's DAC technology |
Diabetes |
Further development activities were put on hold pending completion of Phase I trials of a potentially better product (9/30) |
| ||||
Cytomedix |
AutoloGel |
Platelet releasate therapy system |
Diabetic foot ulcers |
Preliminary analysis of trial showed potentially similar efficacy as the standard therapy (9/12) |
| ||||
INFECTION | ||||
Arrow |
A-60444 |
Small-molecule inhibitor of protein involved in viral replication |
Respiratory syncytial virus |
Got OK to expand its Phase IIa trial into the U.S. in adult patients infected with RSV after bone marrow transplantation (9/12) |
| ||||
AVI |
AVI-4065 |
Neugene antisense compound |
Hepatitis C |
Began exploratory trial to assess safety, tolerability, pharmacokinetics and viral response in 40 healthy volunteers followed by 40 patients (9/28) |
| ||||
BioAlliance |
Miconazole Lauriad |
Oral, bioadhesive buccal tablet containing the antifungal miconazole |
Oropharyngeal candidiasis |
Starting a pivotal Phase III trial in the U.S. in HIV-positive patients (9/6) |
| ||||
Coley |
Actilon (CPG 10101) |
Agent designed to target and stimulate Toll-like receptor 9 |
Hepatitis C |
Began Phase Ib trial to assess safety, tolerability and virus levels in 60 patients separated into various regimens (9/27) |
| ||||
CytRx Corp. |
DP6-001 |
Vaccine formulation based on five strains of HIV |
HIV |
Phase I trial showed vaccine was well tolerated, stimulated T cells and produced antibody responses against multiple HIV strains (9/7) |
| ||||
GenVec Inc. |
-- |
Adenovector-based booster HIV vaccine developed with the Vaccine Research Center |
HIV |
Data from eight healthy volunteers in Phase I trial showed tolerability and a cellular and antibody immune response (9/7) |
| ||||
IDM Pharma |
EP HIV-1090 |
HIV DNA vaccine |
HIV |
Phase I trial in 40 patients established safety and the utility of DNA vaccines for the delivery of multiple CTL epitopes (9/7) |
| ||||
Inhibitex |
Veronate |
Antibody-based immune globulin |
S. aureus infections in low-birth-weight infants |
Monitors recommended Phase III trial continue after reviewing data on 1,500 patients (9/6) |
| ||||
MedImmune |
Numax |
Motavizumab; third- generation variant of the anti-RSV antibody Synagis |
Respiratory syncytial virus |
Phase I trial in 30 infants showed drug appeared to be safe and reduced RSV in the upper respiratory tract (9/1) |
| ||||
Nabi Bio- |
StaphVAX vaccine |
Staphylococcus aureus polysaccharide conjugate infections |
To prevent S. aureus |
Immunogenicity trial showed 94% of patients undergoing orthopedic surgery with a prosthetic device implant achieved desired antibody levels (9/29) |
| ||||
Nabi Bio- |
StaphVAX |
Staphylococcus aureus polysaccharide conjugate vaccine |
To prevent S. aureus infections |
Began trial to evaluate vaccine in a subset of 460 end-stage renal disease patients from ongoing Phase III trial (9/20) |
| ||||
Oscient |
Factive (FDA-approved) |
Gemifloxacin mesylate; a fluoroquinolone antibiotic |
Community- acquired pneumonia |
Final data from pivotal Phase III trial showed non-inferiority of five-day treatment vs. the approved seven-day treatment (9/19) |
| ||||
Progenics |
PRO 140 |
Humanized monoclonal antibody against CCR5; HIV entry inhibitor |
HIV |
Dose-dependent binding of PRO 140 to CCR5-expressing cells was seen in a Phase I trial (9/9) |
| ||||
Tanox Inc. |
TNX-355 |
Humanized anti-CD4 monoclonal antibody; designed to inhibit viral entry |
HIV |
Monitors recommended continuation of Phase II trial after planned 20-week interim safety analysis (9/13) |
| ||||
XTL Bio- |
XTL-6865 |
Combination of two fully human monoclonal antibodies (Ab68 and Ab65) against the HCV E2 envelope protein |
Hepatitis C |
Began a Phase Ia trial in the U.S. and Israel (9/29) |
| ||||
MISCELLANEOUS | ||||
Adolor Corp. |
Entereg |
Alvimopan capsules; mu opioid antagonist |
Opioid-induced constipation |
Began Phase III trial that will assess efficacy vs. placebo in about 1,700 patients (9/12) |
| ||||
Altus |
ALTU-238 |
Long-acting, crystalline formulation of recombinant human growth hormone |
Growth hormone deficiency |
Presented positve data from Phase I trial in healthy adults, and began Phase II trial (9/28) |
| ||||
Biovitrum AB* |
BVT.28949 |
Agent in eye-drop form designed to lower intraocular pressure by increasing the outflow of aqueous humor |
Glaucoma |
Began Phase I trial to test safety in 60 healthy volunteers (9/13) |
| ||||
Discovery |
Aerosurf |
Aerosolized surfactant replacement therapy |
Respiratory distress syndrome in premature babies |
Pilot Phase II trial in 17 infants demonstrated feasibility of delivery, and that treatment was generally safe and well tolerated (9/8) |
| ||||
Discovery |
Surfaxin |
Engineered version of natural human lung surfactant |
Respiratory distress syndrome in premature babies |
Analysis vs. animal-derived surfactants showed advantages in survival, days in intensive care and hospital costs (9/1) |
| ||||
Exelixis Inc. |
XL784 |
Inhibitor of the ADAM-10 matrix metalloprotease enzyme |
Renal failure |
Began repeat-dose Phase I trial in healthy volunteers to prepare for a Phase II program (9/22) |
| ||||
Genzyme |
Myozyme |
Recombinant human acid alpha-lucosidase enzyme |
Late-onset Pompe disease |
Began trial to evaluate safety and efficacy in at least 72 patients (9/15) |
| ||||
Genzyme |
Renagel (FDA-approved) |
Sevelamer hydrochloride; phosphate binder |
Renal disease |
RIND trial in 129 patients new to dialysis showed a statistically significant improvement in coronary artery calcification vs. calcium-based phosphate binders (9/29) |
| ||||
GTx Inc. |
Ostarine |
Selective androgen receptor modulator |
Muscle wasting associated with burns |
Reported positive results from Phase I trial (9/7) |
| ||||
Indevus |
Sanctura XR |
Once-daily version of FDA-approved trospium chloride agent |
Overactive bladder |
Began Phase III program consisting of two 12-week studies that will evaluate efficacy in 1,200 patients (9/8) |
| ||||
ISTA |
Vitrase (FDA-approved) |
Ovine hyaluronidase formulation |
Vitreous hemorrhage |
Pooled data from Phase III studies demonstrated a statistically significant reduction in vitreous hemorrhage density (9/7) |
| ||||
Nastech |
PTH1-34 |
Intranasal formulation of a fragment of naturally occurring human parathyroid hormone |
Osteoporosis |
Phase I trial in 12 healthy subjects achieved its pharmacokinetic and safety goals (9/29) |
| ||||
NPS |
Preos |
Recombinant human parathyroid hormone |
Osteoporosis |
New analysis from several trials showed improved bone strength and architecture and reduced risk of vertebral fracture (9/27) |
| ||||
Nymox |
NX-1207 |
Investigational agent for BPH |
Benign prostatic hyperplasia |
Interim review of safety data from Phase II trial revealed no serious side effects or safety issues (9/14) |
| ||||
QLT Inc. |
Visudyne (FDA-approved) |
Verteporfin for injection; aphotodynamic therapy |
Wet age-related macular degeneration |
Visudyne in occult trial did not achieve the primary endpoint at two years in patients with pre-dominantly occult CNV (9/20) |
| ||||
Tercica Inc. |
Increlex (FDA-approved) |
Mecasermin injection; recombinant human insulin-like growth factor-1 |
Short stature caused by IGF deficiency |
Long-term data showed the drug appeared to improve statural growth and generally was well tolrated (9/23) |
| | ||||
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian 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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