Company* |
Product | Description | Indication |
Status |
AUTOIMMUNE | ||||
ChemoCentryx |
Traficet-EN |
Orally active, anti- inflammatory agent that targets CCR9 |
Crohn's disease |
Phase II data complement earlier results showing improved clinical endpoints (12/4) |
Genmab A/S |
HuMax-CD20 |
Ofatumumab; a fully human antibody targeted at the CD20 molecule found in the cell membrane of B cells |
Rheumatoid arthritis |
Phase II data of the first 100 patients showed a statistically significant proportion of patients on active treatment obtained a 20%improvement of the ACR response compared to placebo (12/5) |
Merck Serono SA(Switzerland; |
Rebif |
Interferon beta-1a 44 mcg |
Multiple sclerosis |
Started a Phase III trial to evaluate the effect of two dosage regimens of the new formulation of Rebif on the time to conversion to multiple sclerosis in people with first clinical symptoms suggestive of the disease (12/12) |
UCB SA (Belgium) |
Cimzia |
Certolizumab pegol; a Fab fragment anti-TNF therapy |
Rheumatoid arthritis |
Top-line Phase III data of Cimzia combined with methotrexate showed superiority to placebo and a statistically significant improvement in the signs and symptoms of RA (12/22) |
ZymoGenetics |
Atacicept |
Antagonist protein that binds to the TNF cytokines BLyS and APRIL |
Rheumatoid arthritis |
Started a Phase II trial with 320 patients (12/20) |
CANCER | ||||
Abraxis |
Abraxane (FDA-approved) |
Paclitaxel protein-bound particles for injection; albumin-bound |
Metastatic breast cancer |
Phase II data of Abraxane vs. Taxotere in first-line treatment showed that weekly Abraxane increased tumor response rate by greater than 60% with less toxicity vs. Taxotere given every three weeks (12/18) |
Active Biotech |
Anyara |
Antibody linked to a toxin designed to stimulate immune system to target and kill cancer cells |
Advanced non- small-cell lung cancer, renal-cell cancer and pancreatic cancer |
Completed three Phase I studies (12/13) |
Adventrx |
CoFactor(ANX-510) |
A folate-based biomodulator drug designed to enhance the activity and reduce the toxicity of 5-fluorouracil |
Refractory metastatic breast cancer |
Started a Phase II trial (12/27) |
Antisoma plc |
AS1411 |
Anti-nucleolin aptamer |
Acute myelogenous leukemia |
Company is advancing it into a Phase II trial in combination with cytarabine (12/13)** |
ArQule Inc. |
ARQ 171 |
Activates under functional checkpoints and enables the cell to detect and respond appropriately to DNA damage |
Advanced solid tumors |
Started a Phase I trial (12/6) |
Avalon |
AVN944 |
Oral, small-molecule drug aimed at inhibiting inosine monosphospate dehydrogenase |
Advanced hematologic malignancies |
Phase I interim results showed it was well tolerated, has dose- dependent pharmacokinetics, induces biomarkers of programmed cell death in cancer cells from patients and has resulted in stabilized disease after a one-month treatment cycle in half the patients treated to date (12/14) |
Bradmer |
Neuradiab |
Monoclonal antibody conjugated to radioactive iodine |
Glioblastoma multiforme |
Company is working with the FDA to design a Phase III trial with a primary endpoint of median overall survival (12/15) |
Cell |
Xyotax |
Paclitaxel poliglumex |
Lung cancer |
Company agreed with the Data Safety Monitoring Board to close the PGT305 trial and take patients off both treatment arms due to the submission of a new protocol and the low rate of deaths in the control group (12/8) |
Chemokine |
CTCE-0214 |
Stable peptide agonist of stromal cell-derived factor-1 |
To help immune system during chemotherapy |
Phase Ib data in 57 healthy patients showed it has the potential to restore a cancer patient's immune system and blood cells between cycles of chemotherapy (12/21) |
Cleveland |
Curaxin CBLC102 |
Hits two key cancer targets: p53 and NF-kB |
Advanced hormone-refractory prostate cancer |
Initiated a Phase II study (12/4) |
Cougar |
CB7630 |
Abiraterone acetate |
Prostate cancer |
Phase I data showed that it was well tolerated at doses as high as 2,000 mg per day with minimal toxicity (12/8); started a Phase II trial for advanced prostate cancer (12/14) |
CuraGen Corp. |
PXD101 |
Belinostat monotherapy |
Cutaneous T-cell lymphoma |
Interim data showed at least two objective responses in the first 13 patients treated; the trial now will enroll up to 34 patients (12/14) |
Cytokinetics Inc. |
Ispinesib |
Kinesin spindle protein inhibitor |
Second-line treatment of renal cell cancer |
National Cancer Institute started a Phase II trial (12/20) |
DNAPrint |
BF-200 ALA |
Combines a nanoemulsion with 5-aminolevulinic acid |
Actinic keratosis |
Finished enrollment in the first part of the Phase IIb/III trial with 80 patients (12/27) |
Dynavax |
TLR9 agonist |
Metastatic colorectal cancer |
Started a Phase I dose-escalation trial in combination with a standard chemotherapeutic regimen (12/5) |
|
EpiCept Corp. |
EPC2407 |
Small-molecule vascular disruption agent and apoptosis inducer |
Advanced solid tumors |
Started a Phase I study (12/20) |
Exelixis Inc. |
XL880 |
- |
Gastric cancer |
Started a Phase II trial (12/22) |
Genentech Inc. |
Avastin |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Metastatic renal-cell carcinoma |
Interim analysis showed a Phase III trial of Avastin in combination with interferon alfa-2a therapy in patients with first-line disease met the primary endpoint by significantly improving progression-free survival compared to interferon alfa-2a therapy alone (12/12) |
Genentech Inc. |
Avastin |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Unresectable, locally advanced recurrent or metastatic non- squamous non- small- cell lung cancer |
Phase III data of Avastin in combination with paclitaxel and carboplatin chemotherapy significantly improved overall survival (12/14) |
Genentech Inc. |
Herceptin (FDA-approved) |
Trastuzumab; monoclonal antibody against the HER2/ neuprotein |
HER2-positive breast cancer |
Results from a second interim analysis of a Phase III study confirmed that, at a three-year median follow-up, Herceptin combined with Taxotere-based regimens significantly improved disease-free survival (12/15) |
Genmab A/S |
HuMax-CD20 |
Ofatumumab; a fully human antibody targeted at the CD20 molecule found in the cell membrane of B cells |
Chronic lymphocytic leukemia |
Started Phase II trial of HuMax-CD20 in combination with fludarabine and cyclophosphamide to treat CLL in previously untreated patients (12/11) |
Genta Inc. |
Genasense |
Oblimersen sodium |
Acute myelogenous leukemia |
A randomized Phase III trial of chemotherapy with or without Genasense failed to meet its primary endpoint of overall survival (12/8) |
GenVec Inc. |
TNFerade |
Adenovector with TNF- alpha gene and a radiation- responsive promoter |
Locally advanced pancreatic cancer |
Independent Data Safety Monitoring Board recommended continuation of a Phase II/III trial after a planned interim analysis of safety data (12/14); Phase II/III data showed a 42.5% absolute increase in overall survival when TNFerade was added to chemo-radiation for the first 51 patients enrolled(12/19) |
GTx Inc. |
Ostarine |
A selective androgen |
Cancer cachexia |
Ostarine met its primary end-point in a Phase II trial and the company plans to start a Phase IIb trial to further confirm efficacy (12/8) |
ImmunoGen Inc. |
Trastuzumab- MCC-DM1 |
Comprises Genentech's trastuzumab anti-HER2 antibody and ImmunoGen's DM1 cell-killing agent |
HER2-positive metastatic breast cancer |
Phase I data show the patient receiving the 2.4 mg/kg dose level had an objective response by RECIST criteria (12/15) |
Immunomedics |
Epratuzumab |
Humanized anti-CD20 monoclonal antibody |
Large B-cell lymphoma |
Phase II data showed 87% of patients responded to its combination with Rituxan and ER-CHOP chemotherapy (12/4) |
Introgen |
Advexin |
Adenoviral vector containing the p53 tumor-suppresor gene |
Recurrent squamous cell carcinoma of the head and neck |
Data showed that patients with abnormal p53 biomarker were most likely to have a survival benefit from their use of Advexin (12/11) |
Keryx Biopharma- |
KRX-0401 |
Perifosine; oral agent that modulates AKT and other signal transduction pathways |
Rare sarcomas; |
Started a Phase II program in rare sarcomas (12/14); began a Phase I study of KRX-0401 in combination with Revlimid and dexamethasone in relapsed or refractory multiple myeloma (12/28) |
Kosan |
KOS-953 |
Tanespimycin; an Hsp90 inhibitor |
Trastuzumab- refractory HER2- positive metastatic breast cancer |
Phase II data demonstrated anti-tumor activity (12/14) |
MethylGene Inc. |
MGCD0103 |
Isotype-specific histone deaceytlase inhibitor |
Myelodysplastic syndromes or relapsed or refractory acute myelogenous leukemia |
Started a Phase II trial with up to 82 patients (12/7) |
MethylGene Inc. |
MG98 |
Second-generation antisense compound targeting DNA methyl- transferase |
Metastatic renal-cell cancer |
Company will not pursue additional trials (12/15) |
NeoPharm |
IL13-PE38QQR |
Cintredekin besudotox |
Glioblastoma multiforme |
Failed to meet primary endpoint, showing it was comparable, not statistically superior, to Gliadel (12/11) |
Onyx |
Nexavar (FDA-approved) |
Sorafenib; oral RAF kinase and VEGF inhibitor |
Advanced melanoma |
Phase III failed; did not improve progression-free survival when compared to placebo (12/4) |
OxiGene Inc. |
CA4P |
Intravenous; Combrestatin A-4 Phosphate |
Advanced imageable malignancies |
Completed a 13-patient Phase II study that identified the optimal dose and demonstrated safety and efficacy (12/27) |
Point |
Talabostat |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
Stage IIIb/IV non-small- cell lung cancer |
Phase II data of talabostat in combination with docetaxel showed an overall median pro- gression-free survival of 4 months and an overal median survival of 7.8 months (12/21) |
Seattle |
SGN-40 |
A humanized monoclonal antibody that targets the CD40 antigen |
Diffuse large B-cell lymphoma |
Started a Phase II trial (12/20) |
Sunesis |
SNS-595 |
A cell-cycle modulator |
Ovarian cancer |
Started dosing patients in a Phase II trial as a second-line agent (12/21) |
Telik Inc. (TELK) |
Telcyta |
Canfosfamide; small- molecule, tumor- activated drug designed to induce apoptosis |
Platinum- resistant ovarian cancer and advanced non- small-cell lung cancer |
Telcyta missed its primary end- points of overall survival in two Phase III studies, ASSIST-1 and ASSIST-2; results were skewed in ASSIST-3 as 25% of patients stopped treatment too early (12/26) |
Threshold |
Glufosfamide |
Small molecule targeting abnormal glucose metabolism |
Pancreatic cancer |
Top-line results from a Phase II trial of glufosfamide in combination with gemcitabine showed that 21% of the 28 patients evalu- ated had a partial response and 36% had stable disease (12/28) |
Vertex |
VX-680 (MK-0457) |
Small-molecule inhibitor of Aurora, FLT-3, JAK-2 and BCR-ABL kinases |
Advanced chronic myelogenous leukemia and acute lymphocytic leukemia |
Started a pivotal Phase II study with 270 patients (12/21) |
Xanthus |
Xanafide |
Amonafide malate; ATP- independent topoisom- erase 2 inhibitor |
Secondary acute myeloid leukemia |
Completed enrollment of its Phase II study (12/4) |
| CARDIOVASCULAR | ||||
Actelion Ltd. |
Actelion-1 |
Endothelin receptor antagonist |
Pulmonary hypertension |
The molecule is moving into a Phase III program following Phase II data (12/13)** |
Cardium |
Generx |
Alferminogene tadenovec |
Myocardial ischemia |
Company plans to start a Phase III trial in early 2007 with about 300 women (12/7) |
Critical |
Zyflo |
Zileuton tablets |
Acute exacerbations of chronic obstructive pulmonary disease |
National Institutes of Health will sponsor and fund a trial with 520 patients to see if Zyflo can shorten hospital stays (12/15) |
CV |
Regadenoson |
A selective A2A-adenosine receptor agonist |
Myocardial perfusion imaging |
The second of two Phase III trials met its primary endpoint by showing that regadenoson was comparable to MPI studies conducted with Adenoscan (12/4) |
Cytokinetics |
CK-1827452 |
A cardiac myosin activator |
Cardiovascular indications |
Oral bioavailability results support the advancement of an oral formulation into Phase II trials (12/1) |
Forbes |
FM-VP4 |
Amphipathic analogue of phytostanols; a cholesterol absorption inhibitor |
High cholesterol |
Phase II showed FM-VP4 reduced cholesterol by 9%, missing the 15% reduction required by the FDA (12/4) |
InterMune Inc. |
Pirfenidone |
Small-molecule p38-gamma inhibitor |
Idiopathic pulmonary fibrosis |
Phase III data showed both high and low doses significantly inhibited worsening of the condition compared to placebo (12/22) |
NicOx SA |
Naproxcinod |
Nitric oxide-donating derivative naproxen |
Hypertension |
Top-line data demonstrated a differentiated and favorable 24- hour blood pressure profile com- pared to naproxen after two weeks; it did not reach statistical significance for systolic blood pressure, but it did for diastolic blood pressure (12/8) |
Northfield |
PolyHeme |
Oxygen-carrying blood substitute derived from human blood |
Blood loss |
Top-line data showed that Poly- Heme failed to meet its primary endpoints of superiority and non- inferiority at Day 30 mortality in a Phase III trauma study (12/20) |
Nuvelo Inc. |
Alfimeprase |
Thrombolytic drug; recombinant enzyme that acts by directly degrading fibrin |
Acute peripheral arterial occlusion and catheter occlusion |
Failed two Phase III studies, missing primary endpoints in avoiding open vascular surgery within 30 days of treatment in the PAO setting and of restoring function at 15 minutes in CO (12/11) |
Omrix Bio- |
Fibrin patch |
Bleeding |
Started a Phase I trial for the management and rapid control of bleeding, including severe bleeding during surgery (12/7) |
|
Progenics |
MNTX |
Intravenous methylnaltrexone |
Post-operative ileus |
Started the second of two global, pivotal Phase III trials with about 500 patients (12/21) |
ReNeuron Group |
ReN001 |
Stem cell derived therapy |
Stroke |
Company filed an IND to start a Phase I safety trial (12/13)** |
SciClone |
Zadaxin |
An immunomodulator; synthetic preparation of thymosin alpha-1 |
Skin cancer |
Phase II data showed that all patients receiving Zadaxin with dacarbazine chemotherapy, with or without interferon alpha, had a longer median survival compared to standard-of-care treatment alone (12/22) |
Synthetic Blood |
Oxycyte |
An oxygen carrier; perfluorocarbon- based blood substitute and therapeutic oxygen carrier |
Traumatic brain injury |
Phase IIa data demonstrated that Oxycyte increases brain oxygen tension and glucose metabolism compared to baseline (12/22) |
Trigen |
PR-15 |
Lesion-specific platelet adhesion inhibitor |
Acute arterial thrombosis and to prevent progression of atherosclerosis |
Started a Phase I study (12/14) |
CENTRAL NERVOUS SYSTEM | ||||
Addex |
ADX10059 |
A selective negative allosteric modulator of the metabotropic glutamate receptor 5 |
Moderately severe dental anxiety |
Started a Phase IIa study (12/19) |
Alexza |
AZ-001 |
Staccato prochlorperazine |
Migraine |
Completed patient enrollment in its Phase IIb trial (12/14) |
Alexza |
AZ-003 |
Staccato fentanyl; inhaled formulation |
Acute pain |
Completed enrollment in a Phase I trial; top-line results showed similar pharmacokinetic characteristics to fentanyl administered intravenously (12/21) |
Alkermes Inc. |
XR-NTX |
Injectable extended-release naltrexone |
Opioid dependence |
Phase II data showed that the two highest doses - 150 mg or 300 mg - demonstrated opioid blockade for 28 days (12/4) |
Athenagen Inc.* |
GTS-21 |
Oral alpha-7 nicotinic acetylcholine receptor agonist |
Alzheimer's disease |
Began a Phase II study with 60 patients (12/14) |
Avicena Group |
HD-02 |
Agent that incorporates ultra-pure form of creatine |
Huntington's disease |
Started a chronic toxicology study (12/12) |
Durect Corp. |
DUR-843 |
Transdur bupivacaine; a transdermal pain patch |
Pain |
Completed Phase I trials (12/11) |
EPIX |
PRX-03140 |
Selective serotonin-4 (5-HT4) receptor agonist |
Alzheimer's disease |
Company began a Phase IIa trial to evaluate PRX- 3140 as monotherapy and in combination with donepezil (12/5) |
Neurocrine |
CRF1 |
Corticotropin releasing factor R1 receptor antagonist compound |
Social anxiety disorder |
Began a Phase II trial with more than 200 adults (12/20) |
Neurogen |
NG2-73 |
Selective modulator of gamma aminobutyric (GABA) receptors |
Chronic insomnia |
Began a Phase II trial with up to 36 patients (12/20) |
Neuro-Hitech |
Huperzine A |
A second-generation acetylcholinesterase inhibitor |
Alzheimer's disease |
Expanded enrollment level for its Phase II trial on the efficacy of Huperzine A (12/8) |
Pain |
Oxytrex |
Oral painkiller; a combination of oxycodone with ultra-low-dose naltrexone |
Chronic pain |
Began another Phase III trial with 120 subjects (12/13) |
Panacos |
Bevirimat |
A maturation inhibitor; an oral product that targets a step in the HIV lifecycle |
HIV |
Based on the first cohort of patients in a Phase IIb trial, the company is re-examining the formulation (12/20) |
Prana |
PBT2 |
Small molecule that binds metal ions |
Alzheimer's disease |
Began dosing in a Phase IIa trial (12/19) |
Somaxon |
Nalmefene |
Oral drug; opiate antagonist |
Pathological gambling |
Missed primary endpoint in a Phase II/III trial; did not demonstrate a statistically significant difference compared to placebo (12/5) |
Targacept Inc. |
TC-2696 |
Compound discovered using Pentad; modulates specific neuronal nicotinic receptors |
Acute post- operative pain |
Began a Phase II trial in 150 molar extraction patients (12/19) |
Vanda |
Iloperidone |
5HT2/D2 antagonist |
Schizophrenia |
Top-line Phase III data showed that the atypical antipsychotic produced a statistically significant improvement compared to placebo on the positive and negative symptom scale (12/7) |
| DIABETES | ||||
Depomed Inc. |
Gabapentin |
Extended-release formulation |
Diabetic peripheral neuropathy |
Phase II data in 147 patients demonstrated a statistically significant reduction in average daily pain scores with once-daily therapy (12/12) |
Metabolex Inc.* |
MBX-2044 |
Oral insulin sensitizer; follow-on compound to metaglidasen (MBX-02)a selective PPAR modulator |
Type II diabetes |
Started a Phase IIa trial (12/20) |
Nastech |
NovoLog |
Insulin aspart (rDNA origin) injection and insulin human (rDNA origin) inhalation powder |
Diabetes |
Phase I data showed that three nasal doses had time to maximum plasma level for insulin of 16 to 19 minutes and were the fastest compared to the rapid- acting insulin aspart and inhaled insulin (12/6) |
INFECTION | ||||
Ambrilia |
PPL-100 |
Protease inhibitor |
HIV/AIDS |
The Phase I repeat-dose study demonstrated a good safety profile (12/8) |
Arpida Ltd. |
Iclaprim |
Capsule formulation of broad-spectrum antibiotic |
Complicated skin and skin-structure infection |
The first of two Phase III trials hit the primary endpoint, showing non-inferiority to Zyvox (linezolid) (12/6)** |
Basilea |
BAL8557 |
Isavuconazole; water-soluble azole |
Invasive systemic fungal infections |
Began two Phase III trials to compare BAL8557 with voricona-zole and with a candin-based regimen (12/19) |
Bavarian Nordic |
Imvamune |
Third-generation smallpox vaccine candidate |
HIV |
Phase II data showed the product is equally well tolerated in HIV- infected patients and healthy subjects (12/21) |
Crucell NV |
Rabies monoclonal antibody developed using MAbstract and PER.C6 technology |
Rabies |
Entered a Phase I study in 60 |
|
Crucell NV |
AdVac-based malaria vaccine |
Malaria |
Obtained approval to begin a Phase I study in 96 healthy volunteers (12/19) |
|
Dynavax |
Heplisav |
Immunostimulatory sequence-based vaccine targeting Toll-like receptor 9 |
Hepatitis B virus |
Phase II data show that 100% seroprotection is achieved whether the second dose is administered one or two months after the first (12/4) |
GenVec Inc. |
Vaccine based on GenVec's adenovirus vector technology |
HIV |
Phase I data show the vaccine is safe and well tolerated in healthy adult volunteers at multiple doses (12/15) |
|
Human Genome |
Albuferon |
Albinterferon alpha 2b |
Chronic hepatitis C |
Started dosing in ACHIEVE 1, one of two pivotal Phase III trials of Albuferon in combination with ribavirin (12/19) |
Immtech |
DB289 |
Pafuramidine maleate; oral, dicationic antiviral agent |
Malaria |
Started a Phase I trial to prevent malaria for travelers to endemic regions (12/11) |
NexMed Inc. |
NM100060 |
Terbinafine; topical |
Nail fungus |
Pivotal Phase III trials began (12/14) |
Progenics |
PRO 140 |
Humanized monoclonal antibody designed to work as a viral entry inhibitor |
HIV |
Completed enrollment and dosing in a Phase Ib trial (12/14) |
Replidyne Inc. |
Faropenem medoxomil |
Oral liquid antibiotic |
Pediatric acute otitis media; acute exacerbation of chronic bronchitis |
Completed enrollment for a Phase II trial of more than 300 children (12/20); Phase III data comparing faropenem to placebo and Ketek was stopped while the company considers removing the Ketek arm due to risks that outweigh the benefits of the drug (12/26) |
Somaxon |
Silenor |
Doxepin; low-dose of the approved depression drug doxepin |
Chronic primary insomnia |
Phase III data demonstrated a statistically significant improvement compared to placebo in the primary endpoint, wake after sleep onset as measured at night one (12/18) |
Theratechnol- |
TH9507 |
Stabilized analogue of the growth hormone-releasing factor |
HIV-associated lipodystrophy |
TH9507 met its primary endpoint achieving a 15% visceral adipose tissue reduction vs. baseline and a 20% reduction vs. placebo at 26 weeks (12/19) |
Vertex |
VX-950 |
Telaprevir; protease inhibitor against HCV |
Hepatitis C virus |
Phase IIb results showed 88% of patients demonstrated undetectable HCV RNA at week 12, compared to 52% in the control arm (12/13) |
| MISCELLANEOUS | ||||
Allergy |
Vaccine that incorporates the adjuvant MPL, a TLR4-agonist |
Hay fever |
Phase IIa data is promising and full results will be available in the first quarter (12/13)** |
|
Amicus |
AT2220 |
Small molecule designed to act as a pharmacological chaperone that specifically binds, stabilizes and facilitates the proper folding and trafficking of GAA to the lysosome |
Pompe's disease |
Began Phase I trials (12/14) |
Auxilium |
AA4500 |
An injectable enzyme product |
Dupuytren's contracture |
Auxilium suspended patient dosing in two ongoing Phase III studies after a quarter of the lots manufactured failed to pass a visual inspection (12/7) |
AVI BioPharma |
ESPRIT |
Exon Skipping Pre-RNA Interference Technology; designed to delete disease- causing gene sequences |
Duchenne's muscular dystrophy |
Started a clinical program (12/7) |
Avigen Inc. |
AV650 |
Orally administered centrally acting small molecule |
Disabling neuromuscular spasticity and spasm |
Completed a Phase I trial (12/6) |
BioMimetic |
GEM OS1 Bone Graft |
Recombinant platelet-derived growth factor combined with a synthetic bone matrix |
Foot and ankle fusions |
Reported positive results from 20-patient feasibility trial showing the product is as effective as autograft for the stimulation of bone healing, without the pain and morbidity associated with the harvesting of the autograft (12/13) |
BioSante |
LibiGel |
Transdermal testosterone gel |
Female sexual dysfunction |
Started a Phase III trial with 360 surgically menopausal women (12/28) |
Columbia |
Prochieve 8% (FDA-approved) |
Progesterone gel |
To prevent recurrent preterm birth |
Completed treatment phase of the pivotal Phase III study with 669 patients (12/22) |
Gilead |
Aztreonam lysine for inhalation |
Cystic fibrosis |
Phase III data showed it met its primary endpoint in CF patients with pulmonary Pseudomonas aeruginosa; endpoint was time to need for inhaled or I.V. antibiotics after a 28-day treatment course (12/20) |
|
Inspire |
Epinastine nasal spray formulation |
Seasonal allergic rhinitis |
Started a Phase II trial in 580 subjects (12/5) |
|
Lexicon |
LX1031 |
Small molecule that reduces the serotonin available for receptor activation in the GI tract |
Gastrointestinal disorders |
Submitted an investigational new drug application to begin a Phase I trial (12/5) |
MediciNova Inc. |
MN-221 |
Intravenous; a highly selective Beta2-adrenergic receptor agonist |
Status asthmaticus |
Began a Phase II study with 28 mild-to-moderate asthma patients (12/19) |
MGI Pharma |
Aloxi (FDA-approved) |
Palonosetron hydrochloride injection |
Post-operative nausea and vomiting |
Completed two Phase III trials, both of which met their primary efficacy endpoints of complete response for the prevention of post-operative nausea and vomiting in the first 24 hours following surgery (12/14) |
Nastech |
PYY(3-36) |
Nasal spray formulation of the Y2 receptor agonist |
Obesity |
Clinical trial in 24 patients showed a statistically significant treatment effect and a reduction in calorie intake (12/21) |
Neurocrine |
CRF1 |
Corticotropin releasing factor R1 receptor antagonist compound |
Irritable bowel syndrome |
Began a Phase II trial with about 100 patients (12/20) |
Orphan |
Lucassin |
Terlipressin; peptide derived from the natural hormone lysine vasopressin |
Type I hepato-renal syndrome |
Missed statistical significance in a Phase III trial (12/19) |
Osteologix Inc. |
NB S101 |
Tablet formulation of strontium, a product in Europe |
Osteoporosis |
Started a double-blind, placebo- controlled Phase II trial (12/5) |
Othera |
OT-551 |
Topical eye drop formulation of a catalytic antioxidant |
Geographic atrophy |
Enrolled its first patient in a Phase II trial (12/7) |
Repros |
Proellex (Progenta) |
Agent designed to block progesterone without blocking adrenal hormones |
Endometriosis and uterine fibroids |
Phase II data show that those given the highest dosage (50 mg) achieved statistically significant pain reduction compared to treatment with Lucrin/Lupron, the standard of care (12/18); Phase II data show patients treated with the drug had a statistically significant improvement in symptoms associated with uterine fibroids (12/21) |
Repros |
Androxal |
Small-molecule agent designed to restore normal testosterone production in males |
Testosterone deficiency |
Interim Phase III results suggest that treatment results in a statistically significant increase in mean testosterone and demonstrated non-inferiority for all parameters compared to Androgel (12/20) |
Sirion |
Fenretinide |
Oral compound designed to reduce lipofuscin accumulation by lowering degeneration |
Geographic atrophy in age-related macular the body's level of serum retinol |
Began enrollment of a Phase II trial (12/4) |
Notes: | ||||
* Privately held; ** The date the item ran in BioWorld International. | ||||
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; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange. | ||||
