Company* |
Product |
Description |
Indication |
Status (Date) |
AUTOIMMUNE | ||||
Basilea |
Alitretinoin |
Naturally occurring vitamin A derivative |
Severe, chronic hand eczema |
Phase III data showed that patients can benefit from retreatment with the drug (4/25) |
Cerimon |
Simulect (FDA-approved) |
Basiliximab; a monoclonal antibody designed to block the IL- receptor |
Ulcerative colitis |
Started enrolling patients in a Phase IIb study (4/4) |
Merrimack |
MM-093 |
An immunomodulator; a recombinant version of human alpha-fetaprotein |
Rheumatoid arthritis |
Started a Phase II study (4/17) |
Senetek plc |
PRK 124 |
Pyratine 6 compound |
Acne rosacea |
Started trials after a prior study showed it was well tolerated and exhibited reductions in erythema (4/11) |
CANCER | ||||
Advaxis Inc. |
Lovaxin C |
A modified Listeria- based live vaccine |
Advanced, recurrent or progressive cervical cancer |
Completed enrollment and dosing of the third cohort of patients in a Phase I/II trial (4/17) |
Alchemia Ltd. |
HyCAMP |
Formulation of the anticancer drug irinotecan |
Metastatic colorectal cancer |
Phase II data showed the patients were able to receive more doses than regular irinotecan and median progression-free survival for HyCAMP patients was 5.2 months, compared to 2.4 months for the irinotecan arm (4/26) |
Ambit |
AC220 |
Designed to inhibit FLT3, a kinase that is mutated in about one-third of AML cases |
Acute myeloid leukemia |
Dosed the first patients in a Phase I trial that will enroll between 20 and 40 patients (4/10) |
Ambrilia |
PCK3145 |
Synthetic peptide analogue of prostate secretory protein |
Metastatic prostate cancer |
Phase I/II data showed evidence of clinical activity (4/24) |
Amgen Inc. |
Aranesp (FDA-approved) |
Darbepoetin alfa; red-blood cell booster |
Anemia in patients with active cancer |
Phase III data showed that transfusion occurrences from weeks five to 17 favored Aranesp but were not statistically significant between the groups (4/13) |
Amgen Inc. |
Aranesp (FDA-approved) |
Darbepoetin alfa; red blood cell booster |
Extensive-stage small-cell lung cancer receiving platinum-containing chemotherapy |
Top-line Phase III data showed it did not raise safety concerns (4/19) |
Antigenics |
Oncophage |
Vitespen; cancer vaccine |
High-grade glioma |
Updated Phase I/II data indicated the drug was associated with significant tumor-specific immune responses in all 12 patients treated (4/16) |
Array |
ARRY-704 |
A selective, orally active MEK inhibitor aimed at blockingsignal transduction pathways |
Cancer |
Dosed the first patient in a Phase I trial (4/12) |
Ariad |
AP32573 |
mTOR inhibitor |
Metastatic sarcomas |
Company changed the planned primary endpoint for an upcoming Phase III trial, from progression-free survival to overall survival (4/6) |
AVAX |
M-Vax |
Autologous vaccine |
Metastatic melanoma |
Phase I/II data confirm that immunological responses induced by M-Vax were similar to those observed with an earlier version of the product (4/16) |
BioDelivery |
BEMA Fentanyl |
Polymer fentanyl disc that adheres to the inner lining of the cheek, where it dissolves in about 30 minutes |
Breakthrough cancer pain |
In a Phase III trial, the drug hit the primary endpoint, Summary of Pain Intensity Difference at 30 minutes, compared to placebo (4/25) |
Bionovo Inc. |
BZL101 |
An oral drug designed to induce cancer cell apoptosis |
Cancer |
Started a Phase I/II trial (4/18) |
Celgene Corp. |
Revlimid (FDA-approved) |
Lenalidomide |
Multiple myeloma |
Preliminary results of Revlimid in combination with low-dose dexamethasone suggests a survival advantage over patients receiving Revlimid plus the higher, standard-dose of dexamethasone (4/4) |
Cell Genesys |
GVAX |
Immunotherapy |
Prostate cancer |
Final Phase II data showed a follow-up of 22 patients with metastatic hormone-refractory disease indicated a median survival of 35 months (4/3) |
Cell |
Xyotax |
A biologicall enhanced version of Taxol |
Advanced non-small-cell lung cancer |
Xyotax qualifies for fast-track designation to treat PS2 women with first-line, advanced cancer (4/11) |
ChemGenex |
Ceflatonin |
Homoharringtonine or HHT |
Chronic myeloid leukemia |
Began a new Phase II/III trial in patients who have failed or are intolerant to treatment with two or more prior tyrosine kinase inhibitors (4/3) |
Cleveland |
Curaxin CBLC102 |
Oral agent that targets p53 and NF-kB |
Advanced, hormone- refractory prostate cancer |
The Phase II efficacy trial progressed to the next phase; it will start with 15 patients and will add 13 more once a PSA response is achieved in at least one patient (4/5) |
Coley |
PF-3512676 |
Toll-like receptor 9 agonist drug candidate |
Advanced non-small-cell lung cancer |
Completed patient enrollment in two pivotal Phase III trials (4/10) |
Cougar |
CB7630 |
Abiraterone acetate; oral, irreversible CYP450c17 enzyme inhibitor |
Prostate cancer |
Phase I/II data showed inhibition of androgen synthesis resulted in a high response rate in castration-refractory prostate cancer (4/17) |
Expression |
EGEN-001 |
Composed of interleukin-12 gene expression plasmid forulated with abiocompatible delivery polymer; uses the TeraPlas delivery technology |
Advanced-stage, recurrent ovarian cancer |
Completed a Phase I study, showing the treatment was well- tolerated with no apparent dose-related trends (4/16) |
Genentech Inc. |
Tarceva (FDA-approved) |
Erlotinib; small-molecule HER1/EGFR inhibitor |
Advanced pancreatic cancer |
Study results show a 22% improvement in survival when Tarceva is added to gemcitabine chemotherapy (4/25) |
Genmab A/S |
HuMax-EGFr |
Zalutumumab; human antibody that targets the epidermal growth factor receptor |
Non-small-cell lung cancer |
Started a Phase II study of HuMax-EGFr in combination with chemo-radiation (4/13) |
Genta Inc. |
Genasense |
Oblimersen sodium injection; aimed at blocking the production of Bcl-2 |
Advanced melanoma |
Company said it will conduct a new randomized Phase III trial (4/18) |
Human Genome |
HGS-ETR1 |
Mapatumumab; agonistic human monoclonal antibody to TRAIL receptor |
Advanced solid malignancies |
Phase I data showed the drug could be administered safely and repetitively to 49 patients with advanced solid malignancies (4/27) |
ImClone |
Erbitux (FDA-approved) |
Cetuximab; monoclonal antibody that inhibits the epidermal growth factor receptor |
Pancreatic cancer |
Missed the primary endpoint, failing to improve overall survival to a statistically significant degree in a Phase III trial (4/10) |
ImClone |
Erbitux (FDA-approved) |
Cetuximab; monoclonal antibody that inhibits the epidermal growth factor receptor |
Metastatic colorectal cancer |
Open-label Phase III study comparing Erbitux plus irinotecan to irinotecan alone in patients who failed first-line therapy showed that progression-free survival and response rate were significantly higher in the Erbitux-treated group; the trial missed the primary endpoint, however (4/16) |
Innovive |
INNO-406 |
An oral dual Bcr-Abl and Lyn-kinase inhibitor |
Gleevec-resistant or intolerant chronic myelogenous leukemia |
Phase I data showed the drug was well tolerated at doses up to 240 mg twice-daily (4/16); data showed clinical activity, a 55-fold reduction in Bcr-Abl transcript levels (4/17) |
Introgen |
Advexin |
Adenoviral vector containing the p53 tumor suppressor gene |
Recurrent head and neck cancer |
Phase II data showed that abnormal p53 correlated with increased survival and tumor responses following Advexin treatment (4/16); started the efficacy analyses of its Advexin Phase III study (4/24) |
Introgen |
INGN 401 |
Intravenously administered lipid nanoparticle product candidate |
Stage IV lung cancer |
In a Phase I trial, the gene FUS1 delivered via INGN-401 had cancer-suppressing activity in metastatic non-small-cell lung cancer tumors (4/18) |
Kosan |
KOS-953 |
Tanespimycin, Hsp90 inhibitor |
Multiple myeloma |
Phase I data showed no effect on QTc interval in more than 85 patients, indicating that two prior cases were not related to drug treatment (4/16) |
MediGene AG |
EndoTAG-1 |
A combination of paclitaxel and a delivery system made up of cationic lipids; designed to specifically destroy the blood vessels of tumors |
Breast cancer; pancreatic cancer |
Started a Phase II trial (4/13); Completed recruitment of 200 patients for a Phase II trial (4/25) |
NeoPharm Inc. |
LE-SN38 |
Liposomal formulation of the active metabolite of irinotecan |
Colorectal cancer |
Phase II interim analysis showed a failure to meet the primary endpoint of tumor response (4/2) |
Nereus |
NPI-0052 |
Second-generation proteasome inhibitor |
Multiple myeloma |
Enrolled the first patient in a Phase I trial (4/16) |
OncoGenex |
OGX-011 |
Second-generation anti-sense drug designed to inhibit the production of clusterin, a cell-survival protein |
Metastatic breast cancer |
Phase II data of OGX-011 in combination with docetaxel showed a partial response in five of 15 patients and disease stabilization in nine patients (4/17) |
Oncolytics |
Reolysin |
Intravenous formulation of the human reovirus that targets the activated Ras pathway |
Bone or soft tissue sarcomas |
Started a Phase II, open-label, single-agent cancer trial involving patients whose cancer has metastasized to the lung (4/11) |
Pharmion Corp. (PHRM) |
Vidaza |
Azacitidine, oral; DNA demethylating agent |
Myelodysplastic syndromes, acute myeloid leukemia and malignant solid tumors |
The open-label Phase I study was completed; company is starting a multidose Phase I trial (4/23) |
Progen |
PI-88 |
Anti-angiogenesis drug also designed to inhibit tumor-promoting factors |
Liver cancer |
Phase II data showed PI-88 demonstrated an improvement in disease-free rate, the primary endpoint, of 25% and a prolong- ation in the time to tumor recurrence from 27 to 48 weeks (4/16) |
Provectus |
Provecta |
Agent designed to be retained in tumor cells while leaving normal estrogen tissue unharmed |
Stage III/IV metastatic melanoma |
Completed dosing in the final patient enrolled in its Phase I study (4/24) |
Spectrum |
EOquin |
Apaziquone for intravesical instillation; activated by reductase enzymes found in cancer cells |
Noninvasive bladder cancer |
Phase IIb data showed it was well tolerated and not systemically absorbed (4/19) |
SuperGen Inc. |
MP470 |
Oral, multitargeted tyrosine kinase inhibitor |
Advanced stage solid tumor cancers |
Company is beginning a Phase I trial in up to 30 patients (4/27) |
Telik Inc. |
Telcyta |
Cell-activated chemo drug designed to exploit the overexpression of gluta- thione S-transferase P1-1 |
Non-small-cell lung cancer |
Phase II data showed statistically significant improvements in progression-free survival and overall survival in patients who got Telcyta maintenance therapy compared with those who didn't (4/17) |
Threshold |
Glufosfamide |
Small molecule targeting abnormal glucose metabolism |
Soft-tissue sarcoma |
Started patient enrollment in a Phase II trial (4/9) |
Viventia |
Vicinium |
Armed antibody administered using intravesical instillation |
Locally persistent non- invasive bladder cancer |
Began patient treatment in an open-label Phase II trial that will enroll about 30 patients (4/3) |
CARDIOVASCULAR | ||||
Aastrom |
Tissue |
Consists of a mixture of stem and progenitor cell populations, produced from a small amount of bone marrow taken from the patient |
Peripheral arterial disease |
Started a Phase IIb trial (4/30) |
Anthera |
A-002 |
An inhibitor of secretory phospholipase A2 |
Stable coronary artery disease |
Started enrolling patients in a Phase II trial (4/13) |
Cytokinetics |
CK-1827452 |
A cardiac myosin activator |
Acutely decompensated or chronic heart failure |
Started a Phase II program (4/12) |
Dyax Corp. |
DX-88 |
Recombinant small protein designed to inhibit human plasma kallikrein; ecallantide |
Hereditary angioedema |
Phase III data showed it hit the primary and secondary end- points (4/13); started patient treatment in a Phase III confirmatory study (4/17) |
Genzyme Corp. |
Renvela |
Sevelamer carbonate |
Hyperphosphatemia in chronic kidney disease |
A single-arm, open-label trial involving 49 patients demon- strated a statistically significant reduction in serum phosphorus (4/16) |
Icagen Inc. |
ICA-17043 |
Senicapoc; an ion channel modulator |
Sickle cell disease |
Company is stopping the Phase III ASSERT trial due to a low probability of achieving a reduction in crisis rate, the primary end- point(4/4) |
Liponex Inc.* |
CRD5 |
Agent designed to increase HDL (good cholesterol) levels |
Dyslipidemia |
Phase I/II data indicated that all blood chemistry and blood pres- sure measurements were within normal or expected ranges and the drug was shown to be safe (4/12) |
Rigel |
R788 |
Oral syk kinase inhibitor |
Immune thrombocytopenic purpura |
Company is expanding a Phase II trial based on encouraging preliminary drug activity; also, it began enrolling patients in an open-label Phase II B-cell lymphoma trial (4/11) |
Stem Cell |
NTx-265 |
Technology designed to increase the growth of innate adult stem cells |
Acute stroke |
Phase IIa data showed four of five subjects safely completed a regimen initiated 24 to 48 hours after stroke with no drug-related serious adverse events, while showing substantial recovery (4/10) |
Theravance |
GSK642444 |
Long-acting beta2 agonist compounds |
Asthma and chronic obstructive pulmonary disease |
Phase IIb data showed clinically significant increases in bronchodilation at least equivalent to salmeterol given twice daily (4/3) |
| CENTRAL NERVOUS SYSTEM | ||||
Addex Pharma SA*(Switzerland) |
ADX48621 |
A negative allosteric modulator of the metabotropic glutamate |
Generalized anxiety disorder and receptor 5 inflammatory pain |
Began a Phase I trial (4/11)** |
Addex |
ADX10059 |
A selective, negative allosteric modulator of metabotropic glutamate receptor 5 |
Migraine |
Completed a Phase IIa trial with 129 patients; it achieved its pri- mary objective, a statistically significant absence of pain at two hours after dosing (4/20) |
Ceregene Inc.* |
CERE-120 |
A gene therapy product consisting of an adeno- associated virus vector carrying the gene for neurturin |
Parkinson's disease |
Enrollment is under way in a Phase II trial (4/13) |
BioMS Medical |
MBP8298 |
Synthetic peptide |
Secondary, progressive multiple sclerosis |
A monitoring board recommended continuation of the pivotal Phase II/III trial (4/5) |
Ceregene Inc.* |
CERE-120 |
Gene therapy product that delivers the neurturin gene via an adeno-associated virus Type II vector |
Parkinson's disease |
Phase I data showed the treatment was well tolerated and patients demonstrated a 36% reduction in Parkinson's symptoms at 12 months (4/16) |
EpiCept Corp. |
EpiCept NP-1 |
A topical prescription analgesic cream |
Peripheral neuropathies |
Started two Phase IIb trials (4/10) |
EPIX |
PRX-07034 |
A 5-HT6 antagonist |
Obesity, Alzheimer's disease and cognitive impairment |
Phase Ib data showed PRX-07034 was well tolerated up to 600 mg once per day, with no dose-limiting toxicity identified and no serious adverse events (4/18) |
Hunter-Fleming |
HF0220 |
Cell-protective, naturally occurring human steroid |
Mild to moderate Alzheimer's disease |
Enrolled the first patients into a Phase IIa biomarker study (4/11)** |
Inflazyme |
IPL455,903 |
PDE-4 inhibitor |
Age-associated memory impairment |
Helicon reported unfavorable efficacy data from a Phase IIa trial; the drug showed safety and tolerability, but not significant positive effects on memory and learning (4/9) |
Kalypsys Inc.* |
KD7040 |
A topical inducible nitric oxide synthase inhibitor |
Neuropathic pain |
Started a second Phase I trial (4/16) |
Memory |
MEM 1003 |
A neuronal L-type calcium channel modulator |
Alzheimer's disease |
Completed enrollment in a Phase IIa trial (4/6) |
Opexa |
Tovaxin |
T-cell vaccine |
Multiple sclerosis |
Top-line data from an open-label Phase I/II dose-escalation trial showed the therapy was safe and produced a 90% reduction in annualized relapse rates (4/3) |
Pharmos Corp.(PARS) |
Cannabinor |
Intravenous cannabinoid; synthetic CB2- elective agonist |
Postoperative pain |
Phase IIa data showed it produced a statistically significant decrease in pain vs. placebo when administered at the lowest dose of 12 mg (4/24) |
Pozen Inc. |
Trexima |
A migraine-specific tablet designed to treat inflammation and vasodilation |
Headaches |
Two efficacy studies of more than 2,900 migraine sufferers demon- strated that Trexima provided superior headache relief at two hours and four hours compared to placebo, and 2- through 24-hour sustained pain-free results vs. sumatriptan or naproxen monotherapy (4/4) |
Valeant |
Retigabine |
First-in-class neuronal potassium channel opener |
Epilepsy |
Phase II data showed it was efficacious with a demonstrated reduction in monthly seizure rates (4/11) |
| DIABETES | ||||
Alimera Sciences |
Medidur |
A tiny, injectable intravitreal insert that delivers a low dose of fluocinolone acetonide, a corticosteroid, to the retina for up to three years |
Diabetic macular edema |
Enrollment for the Phase III global trial has exceeded 50% (4/23) |
Avanir |
Zenvia |
A combination of dextro-methorphan and the enzyme inhibitor quinidine |
Diabetic neuropathic pain |
Phase III data showed it met the primary endpoint of pain reduction(4/18) |
Metabasis |
MB07803 |
Second member of a new class that inhibits a metabolic pathway in the liver called gluconeogenesis |
Type II diabetes |
Started a Phase IIa trial (4/4) |
Pharmacopeia |
PS433540 |
A dual-acting angiotensin and endothelin receptor antagonist |
Hypertension and diabetic nephropathy |
Phase I data showed the drug was well tolerated at all six doses administered (4/10) |
XOMA Ltd. |
XOMA 052 |
An anti-inflammatory monoclonal antibody targeting interleukin 1-beta |
Type II diabetes |
Plans to start two Phase I trials (4/12) |
INFECTION | ||||
Achillion |
ACH-806 |
NS4A antagonist |
Hepatitis C virus |
Data validates the clinical activity of ACH-806 (4/16) |
AlphaVax Inc.* |
|
Human version of an alphavaccine; and a flu alphavaccine that contains the hemag- glutinin gene from a single flu strain |
Cytomegalo- virus and influenza |
Began immunizing volunteers in trials (4/11) |
Arpida Ltd. |
AR-709 |
A DHFR inhibitor administerred as radiolabeled microdoses pneumoniae |
Streptococci and multidrug- resistant Streptococcus |
Arpida said the microdoses achieved good distribution within the lungs in a first-in-man study (4/4)** |
Astellas |
Telavancin infections |
Lipoglycopeptide; bactericidal injectable antibiotic |
Complicated skin and skin structure |
Two Phase III trials showed telavancin compared favorably to standard therapy (4/2) |
Astellas |
Mycamine |
Micafungin sodium |
Candida infections |
Mycamine compared favorably to standard therapy and provided significant safety advantages (4/2) |
Helix |
|
Topical interferon alpha-2b |
Human papillomavirus |
Treatment caused abnormal Pap smears to revert to normal for 46.7% of women in a Phase II trial (4/2) |
Human Genome |
Albuferon |
Albinterferon alfa-2b; long- acting form of interferon alpha, created with albumin fusion technology |
Genotype 1 chronic hepatitis C virus |
Phase IIb data of Albuferon in combination with ribavirin in patients naive to interferon alpha-based treatment regimens showed it provided at least comparable efficacy to Pegasys. with a 59% rate of sustained virologic response at 12 weeks vs.54% for Pegasys (4/16) |
Idenix |
Valopicitabine |
An HCV RNA polymerase inhibitor |
Hepatitis C virus |
Phase IIb data of valopicitabine in combination with pegylated interferon alfa-2a showed that 53% of treatment-naive patients achieved undetectable HCV levels; a second study showed the end- f treatment sustained viral response rates and post- treatment SVR rates were comparable for treatment- experienced patients (4/12) |
Idenix |
Sebivo |
Telbivudine; once-a-day tablet |
Hepatitis B virus |
Results from a comparative study showed Sebivo provided more rapid and profound viral suppression than adefovir (4/13) |
Immtech |
DB289 |
Pafuramidine maleate; oral agent |
Uncomplicated malaria caused by Plasmodium Falciparum |
Started a Phase IIb trial (4/9) |
Intarcia |
Omega interferon |
Recombinant, glycosylated human type-1 interferon |
Hepatitis C virus |
Phase II data showed the combination of omega interferon with ribavirin was well tolerated and had robust antiviral activity (4/13) |
Iomai Corp. |
|
Vaccine that uses heat labile toxin produced by E. coli |
Travelers' diarrhea |
Phase II data showed the vaccine produced positive results even at the lowest dose tested (4/26) |
LigoCyte |
|
Intranasally-delivered, dry powder vaccine based upon virus-like particles |
Norovirus |
Started a Phase I trial (4/3) |
MacroChem |
EcoNail |
A topical antifungal lacquer; contains econazole and MacroChem's enhancer SEPA |
Onychomycosis |
Completed enrollment in a 40-patient, open-label Phase II study (4/11) |
NanoBio Corp.* |
NB-002 |
Topical treatment |
Onychomycosis |
Began enrolling patients in a Phase II trial designed to enroll about 1,000 patients (4/3) |
Nautilus |
Belerofon |
Long-lasting human interferon alpha; subcutaneous |
Chronic hepatitis C virus |
Started a Phase I trial (4/2) |
Novagali Pharma |
Vekacia |
A topical cyclosporine A cationic emulsion |
Vernal kerato-conjunctivitis |
Phase III data showed that both symptoms and signs of disease improved in patients taking Vekacia (4/4) |
Orchestra Therapeutics Inc.|(formerly The |
Remune and IR103 |
HIV-1 immunogen; and HIV-1 immunogen with Amplivax |
HIV |
Company is terminating the Phase II programs and looking for strategic alternatives for them (4/4) |
Pharmexa- |
EP1233 and MVA-BN Polytope |
HIV vaccine and multi- valent vaccine vector |
HIV |
Started Phase I testing (4/30) |
Vertex |
VX-950 |
Protease inhibitor telaprevir |
Hepatitis C virus |
Data from the first trial of VX-950 in combination with pegylated interferon and ribavirin showed a high rate of rapid viral response and a low rate of on-treatment viral breakthrough (4/16) |
ViroPharma Inc. |
HCV-796 |
An oral HCV polymerase inhibitor |
Hepatitis C virus |
Phase Ib data of HCV-796 with pegylated interferon alfa-2b demonstrated additive antiviral effects of the drug across multiple genotypes of HCV infection (4/13) |
| MISCELLANEOUS | ||||
Addex |
ADX10059 |
A selective mGluR5 negative allosteric modulator |
Gastroesophageal reflux disease |
Phase IIa data showed the compound met its primary endpoint and showed statistically significant improvements in many of the secondary measures (4/17) |
Adolor Corp. |
Entereg |
A peripherally acting mu-opioid receptor antagonist; alvimopan |
Opioid-induced constipation |
Top-line Phase III data showed an increased risk of serious cardiovascular events in patients receiving Entereg compared to placebo (4/10) |
Advanced |
Ferumoxytol |
Intravenous iron replacement therapy |
To replace iron |
Reported positive results from two additional Phase III trials; it met all primary and secondary endpoints in the first study and showed treatment- elated adverse events in 5.2% of patients receiving ferumoxytol and 4.2% of those receiving placebo (4/12) |
AEterna |
Cetrorelix antagonist |
A luteinizing hormone- releasing hormone |
Benign prostatic hyperplasia |
Began the first Phase III study (4/19) |
Affymax Inc.* |
Hematide |
Synthetic, peptide-based erythropoiesi stimulating agent |
For dialysis patients |
Phase II data showed that mean hemoglobin levels can be main- tained at clinically acceptable levels following a switch to Hematide dosed monthly from three-times-weekly epoetin alfa (4/12) |
Allergy |
Pollinex Quattro adjuvant |
Short course hay fever vaccine with TLR4- gonist |
Ragweed allergy |
Began dosing in the pivotal Phase III trial (4/4)** |
Amarin Corp. |
Miraxion |
Compound that inhibits certain enzymes, including phospholipases and caspases |
Huntington's disease |
Drug failed to hit primary and secondary endpoints in two Phase III studies (4/24) |
Antares Pharma |
Anturol |
Oxybutynin ATD transdermal gel |
Overactive bladder |
Study results showed it was absorbed on a bioequivalent basis after a single dose (4/19) |
CoMentis Inc.* |
ATG3 |
A topical eye drop therapy; formulation of mecamylamine; an antagonist of of the nicotinic acetylcholine receptor pathway |
Neovascular age-related macular degeneration |
Started a Phase II trial (4/10) |
Eurand |
Zentase (formerly EUR-1008) |
A porcine-derived pancreatic enzyme replacement therapy |
Exocrine pancreatic insufficiency |
Phase III data showed two trials met all primary and secondary endpoints (4/4) |
GTx Inc. |
Ostarine |
Selective androgen receptor modulator |
Chronic kidney disease muscle wasting |
Phase II data revealed that insulin and glucose levels were reduced and insulin resistance was improved among subjects receiving the 3 mg dose compared to baseline (4/17) |
Lexicon |
LX1031 |
Designed to act locally in the gastrointestinal tract by reducing the serotonin available for receptor activation |
Irritable bowel syndrome |
Started a Phase Ib trial with 40 healthy volunteers (4/24) |
Neurotech |
NT-501 |
Encapsulated Cell Technology product |
Retinitis pigmentosa |
Started enrollment in Phase II/III trials in visual loss associated with retinitis pigmentosa (4/17) |
NicOx SA |
Naproxcinod |
From the COX-inhibiting nitric oxide-donating class |
Osteoarthritis of the knee |
Started the second pivotal Phase III trial, which will enroll 1,020 patients (4/3) |
Nymox |
NX-1207 |
Investigational agent for BPH |
Benign prostatic hyperplasia |
Completed a 42-month follow-up study, which evaluated symptomatic progress of patients involved in the company's two Phase I/II studies (4/18) |
Obecure Ltd.* |
OBE101 |
Candidate comprised of betahistamine |
Obesity |
Completed enrollment for a Phase II trial with 281 patients (4/11) |
Osteologix Inc. |
NB S101 |
Once-daily tablet containing strontium malonate as its active ingredient |
Osteoporosis |
Completed enrollment in its Phase II study with 289 post- menopausal women with low bone mineral density (4/18) |
Protalix |
prGCD |
A plant cell-expressed recombinant form of human glycocerebrosidase |
Gaucher's disease |
Plans to start a Phase III trial (4/18) |
Repros |
Proellex |
Oral agent designed to block progesterone without blocking adrenal hormones |
Uterine fibroids |
Phase II data suggested that treatment resulted in a statistically significant improvement in symptoms associated with uterine fibroids and is generally well tolerated (4/3) |
Resistentia |
RP01 |
An anti-IgE imunotherapy |
Allergies |
Started a Phase II trial with 42 patients (4/19) |
XenoPort Inc. |
XP13512 |
Gabapentin prodrug |
Restless legs syndrome |
Drug met its endpoints in the first of three Phase III studies (4/25) |
Y's Therapeutics |
YSPSL |
Recombinant P-selectin glycoprotein immunoglobulin |
To prevent delayed graft function in kidney transplant patients |
Completed patient enrollment in its Phase II trial (4/24) |
Notes: | ||||
* Privately held. ** Denotes 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; ASX = Australian Stock Exchange; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange. | ||||