Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Ablynx NV (Ghent, Belgium) |
ATN-103 |
Tumor necrosis factor alpha inhibitor |
Rheumatoid arthritis |
48-week extension study data showed that 38% of treated patients achieved clinical remission |
6/26/12 |
AB Science SA (Paris) |
Masitinib |
An oral tyrosine kinase inhibitor |
Multiple sclerosis |
Phase II data showed 32% of patients treated with masitinib were responders compared to 0% in the placebo group |
6/14/12 |
Anthera Pharmaceuticals Inc. (Hayward, Calif.) |
Blisibimod |
A selective antagonist of B-cell activating factor |
Systemic lupus erythematosus |
Failed to meet the primary efficacy endpoint in a Phase IIb trial |
6/29/12 |
Chelsea Therapeutics Inc. (Charlotte, N.C.) |
CH-4051 |
The L-isomer of CH-1504 and second drug candidate from its bioavailable, non-metabolized antifolate portfolio |
Rheumatoid arthritis |
Phase II trial failed to meet its primary endpoint of superiority over methotrexate |
6/1/12 |
ChemoCentryx Inc. (Mountain View, Calif.) |
CCX354 |
A selective, oral inhibitor of chemokine receptor |
Rheumatoid arthritis |
Phase II data showed it was generally well tolerated and showed evidence of clinical activity using the ACR20 response criteria at week 12 |
6/11/12 |
Incyte Corp. (Wilmington, Del.) and Eli Lilly and Co. (Indianapolis) |
Baricitinib |
An orally available janus kinase inhibitor |
Rheumatoid arthritis |
Phase IIb data showed the primary endpoint was achieved |
6/11/12 |
Medigene AG (Martinsried, Germany) |
RhuDex |
A CD80 antagonist that blocks undesired T-cell activation |
Autoimmune diseases |
A clinical formulation trial showed it achieved positive results and that the further clinical development of the drug will continue with an optimized formulation; a Phase II is planned before the end of the year |
6/22/12 |
Photocure ASA (Oslo, Norway) |
Visonac |
Methyl aminolevulinate |
Acne |
Phase IIb data demonstrated a statistically significant reduction in inflammatory lesions and overall improvement in acne severity |
6/1/12 |
CANCER | |||||
Aeterna Zentaris Inc. (Quebec) |
Perifosine |
Oral cancer drug |
Advanced renal cell carcinoma |
Phase II data showed one patient achieved a partial response and 11 patients had stable disease as their best response; in a second trial, five patients had a partial response and 16 had stable disease |
6/19/12 |
Astex Pharmaceuticals Inc. (Dublin, Calif.) |
SGI-110 |
A hypomethylating agent |
Myelodysplastic syndromes or acute myeloid leukemia |
Started the Phase II dose-expansion segment, enrolling treatment-naive MDS and elderly AML patients |
6/25/12 |
Cell Therapeutics Inc. (Seattle) |
Tosedostat |
An oral, aminopeptidase inhibitor |
Newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome |
Began enrolling patients in a Phase II trial testing tosedostat with either cytarabine or decitabine |
6/19/12 |
Curis Inc. (Lexington, Mass.) |
Erivedge |
Vismodegib |
Basal cell nevus syndrome and surgically eligible basal cell carcinoma |
Data demonstrated proof-of-concept efficacy in the pivotal Phase II trial |
6/8/12 |
Genta Inc. (Berkeley Heights, N.J.) |
Tesetaxel |
Oral taxane |
Recurrent breast cancer |
Accrued its first patient in a Phase IIb trial |
6/1/12 |
Glycotope (Berlin) |
PankoMab-GEX |
Based on Glyco-Bodies technology and recognizes carbohydrate based tumor epitopes |
Ovarian cancer |
Company is planning to advance into Phase II after a Phase I showed it exhibited very good tolerability with no significant toxicity and strong signals for high antitumor activity and specificity |
6/18/12 |
GTx Inc. (Memphis, Tenn.) |
Enobosarm |
A selective androgen-receptor modulator |
Cancer |
Phase IIb data showed it may play a role in the management of cancer patients with muscle wasting by improving physical function |
6/27/12 |
Infinity Pharmaceuticals Inc. (Cambridge, Mass.) |
IPI-926 |
Saridegib |
Chondro-sarcoma |
Interim Phase II data indicated the treatment was similar to placebo and the trial would not meet its primary endpoint; it was well tolerated, but Infinity is stopping the trial |
6/19/12 |
Nymox Pharmaceutical Corp. (Hasbrouck Heights, N.J.) |
NX-1207 |
Administered by intraprostatic injection |
Low-risk localized prostate cancer |
Enrolled the first patient in the Phase II study |
6/13/12 |
OncoSec Medical Inc. (San Diego) |
DNA IL-12 |
Plasmid interleukin-12 with electroporation |
Stage III or Stage IV cutaneous and in-transit metastatic melanoma |
Phase II trial completed about 50% of enrollment, with no Grade 3 or higher adverse events related to treatment reported |
6/27/12 |
Provectus Pharmaceuticals Inc. (Knoxville, Tenn.) |
PV-10 |
Designed to selectively target and destroy cancer cells without harming surrounding healthy tissue |
Metastatic melanoma |
Top-line Phase II data showed an objective response rate of 50% in target lesions and 70% disease control |
6/27/12 |
Synta Pharmaceuticals Corp. (Lexington, Mass.) |
Ganetespib |
Hsp90 inhibitor |
Non-small-cell lung cancer |
Interim Phase IIb data showed a strong separation for ganetespib plus docetaxel in the adenocarcinoma population on overall survival |
6/29/12 |
CARDIOVASCULAR | |||||
Acorda Therapeutics Inc. (Hawthorne, N.Y.) |
Ampyra |
Dalfampridine extended-release tablets |
Stroke |
The first patient was enrolled in a proof-of-concept study |
6/13/12 |
BioInvent International AB (Lund, Sweden) and Thrombo-Genics NV (Leuven, Belgium) |
TB-402 |
Anticoagulation antibody |
For patients undergoing hip replacement surgery |
Halted development following unfavorable data from a Phase IIb head-to-head trial against Xarelto |
6/6/12 |
FibroGen Inc. (San Francisco) |
FG-4592 |
Oral hypoxia-inducible factor prolyl hydroxylase inhibitor |
Anemia in chronic kidney disease |
Phase II data demonstrated that it reduced blood pressure in hypertensive patients, reduced cholesterol levels and improved the ratio of high-density lipoprotein to low-density lipoprotein |
6/5/12 |
Stealth Peptides Inc. (Boston) |
Bendavia |
Targets the mitochondrion |
Ischemia reperfusion and microvascular injuries |
The first patient was enrolled in its Phase II study |
6/26/12 |
CENTRAL NERVOUS SYSTEM | |||||
Addex Therapeutics Ltd. (Geneva) |
ADX71149 |
A positive allosteric modulator of metabotropic glutamate receptor 2 |
Major depressive disorder |
Initiated a Phase II study |
6/6/12 |
Addex Therapeutics Ltd. (Geneva) |
Dipraglurant |
A small-molecule allosteric modulator |
Parkinson's disease |
Phase IIa data showed it demonstrated statistically significant reduction in LID severity with both 50-mg and 100-mg doses |
6/19/12 |
Cara Therapeutics Inc. (Shelton, Conn.) |
CR845 |
Kappa opioid agonist |
Acute postoperative pain |
Phase II trial met its primary endpoint |
6/12/12 |
Catalyst Pharmaceutical Partners Inc. (Coral Gables, Fla.) |
CPP-109 |
Vigabatrin; a GABA aminotransferase inactivator |
Cocaine addiction |
Phase IIa data showed it did not cause a decrease in visual acuity or significant peripheral visual field changes with short-term use |
6/29/12 |
Civitas Therapeutics Inc. (Chelsea, Mass.) |
CVT-301 |
Inhaled formulation of levodopa |
Motor fluctuations in Parkinson's disease |
Started a Phase IIa trial |
6/18/12 |
Cytokinetics Inc. (South San Francisco) |
CK-2017357 |
An oral fast skeletal muscle troponin activator |
Amyotrophic lateral sclerosis |
Phase II data showed that single oral doses of 250 mg and 500 mg appeared safe and well tolerated |
6/13/12 |
Pharmanest AB (Stockholm, Sweden) |
SHACT |
A product developed for pain relief associated with intrauterine device insertion |
Pain |
Dosed the first patient in a Phase II study |
6/13/12 |
Raptor Pharmaceutical Corp. (Novato, Calif.) |
RP103 |
Cysteamine bitartrate delayed-release capsules |
Huntington's disease |
Completed enrollment in its Phase II/III trial |
6/19/12 |
DIABETES | |||||
Derma Sciences Inc. (Princeton, N.J.) |
DSC127 |
A clinical formulation of NorLeu3-A(1,7) |
Diabetic foot ulcers |
Phase II data showed preliminary evidence that the drug is safe and effective in accelerating healing |
6/28/12 |
Halozyme Therapeutics Inc. (San Diego) |
rHuPH20 |
Recombinant human hyaluronidase enzyme |
Type I diabetes |
Phase II data showed it met the primary endpoint |
6/13/12 |
Lexicon Pharmaceuticals Inc. (The Woodlands, Texas) |
LX4211 |
An oral, dual inhibitor of sodium glucose transporters 1 and 2 |
Type II diabetes |
Showed substantial, dose-dependent, statistically significant reductions in HbA1c levels in a Phase IIb trial in patients concurrently treated with metformin |
6/26/12 |
Noxxon Pharma AG (Berlin) |
NOX-E36 |
Anti-CCL2/MCP-1 Spiegelmer |
Diabetic nephropathy |
Treated the first patient in a Phase IIa trial |
6/20/12 |
Rhythm Pharmaceuticals Inc. (Boston) |
RM-131 |
Ghrelin agonist |
Type I and Type II diabetes |
Started a Phase II trial testing RM-131 for treating gastroparesis in diabetes |
6/7/12 |
INFECTION | |||||
Advaxis Inc. (Princeton, N.J.) |
ADXS-HPV |
Immunotherapy |
Human papillomavirus |
Completed enrollment of 40 patients in a Phase II study |
6/8/12 |
Cempra Inc. (Chapel Hill, N.C.) |
Solithromycin |
A novel ketolide antibiotic |
Uncomplicated urogenital genococcal infections |
Dosed the first two patients in its Phase II trial |
6/13/12 |
CytoPharm Inc. (Taipei, Taiwan) and Amarillo Biosciences Inc. (Amarillo, Texas) |
Oral interferon |
Natural human interferon alpha |
Thrombocytopenia in hepatitis C virus |
Phase II data from a trial in Taiwan showed that patients who received 500 IU IFNa per day had significantly greater mean platelet counts, compared to placebo |
6/15/12 |
Idenix Pharmaceuticals Inc. (Cambridge, Mass.) |
IDX184 |
A nucleotide HCV polymerase inhibitor |
Hepatitis C virus |
Phase IIb data of IDX184 in combination with pegylated interferon and ribavirin showed that 89% of patients who completed their additional 12-week extended-treatment phase, achieved a sustained virologic response four weeks after the completion of treatment |
6/21/12 |
Insmed Inc. (Monmouth Junction, N.J.) |
Arikace |
Liposomal amikacin for inhalation |
Nontuberculous mycobacterial lung disease |
The first patient was dosed in its Phase II study |
6/28/12 |
KaloBios Pharmaceuticals Inc. (South San Francisco) and Sanofi SA (Paris) |
KB001 |
A recombinant human pegylated monoclonal antibody fragment |
Pseudomonas aeruginosa |
Phase IIa data indicated it offers potential as an alternative to antibiotics |
6/26/12 |
Raptor Pharmaceutical Corp. (Novato, Calif.) |
RP103 |
Delayed-release microbead formulation of cysteamine bitartrate |
Nonalcoholic steatohepatitis |
First patient was dosed in its Phase IIb trial |
6/26/12 |
MISCELLANEOUS | |||||
Alkermes plc (Dublin, Ireland) |
ALKS 37 |
An oral, peripherally restricted opioid antagonist |
Opioid-induced constipation |
Company will discontinue development after top-line results from a Phase IIb dose-ranging study failed to meet a predetermined product profile |
6/1/12 |
Biomay AG (Vienna, Austria) |
BM32 |
Vaccine based on a recombinant peptide carrier technology |
Grass pollen allergy |
Showed significant improvements for patients in a Phase IIa trial |
6/15/12 |
GTx Inc. (Memphis, Tenn.) |
Enobosarm |
A selective androgen receptor modulator |
Hypogonadal and eugonadal subjects |
Phase IIb study showed it improved physical function after 16 weeks, compared to placebo |
6/26/12 |
Histogenics Corp. (Waltham, Mass.) |
NeoCart Autologous Cartilage Tissue Implant |
An autologous bioengineered neocartilage grown outside the body using the patient's own cells |
Grade III chondral injury to the femur |
Phase II data showed it had a comparable safety profile to microfracture surgery and significantly improved pain and function within six months of treatment |
6/7/12 |
Hyperion Therapeutics Inc. (South San Francisco) |
Glycerol phenylbutyrate |
A pre-prodrug of phenylacetic acid |
Episodic hepatic encephalopathy |
A 178-patient Phase II trial showed it met its primary endpoint |
6/7/12 |
Ophthotech Corp. (Princeton, N.J.) |
Fovista |
An anti-platelet-derived growth factor agent |
Neovascular age-related macular degeneration |
Phase IIb data showed 1.5-mg Fovista/0.5-mg Lucentis group gained a mean of 10.6 letters of vision on the ETDRS standardized chart after 24 weeks of treatment, compared to 6.5 letters for those receiving only Lucentis |
6/14/12 |
RegeneRx Biopharmaceuticals Inc. (Rockville, Md.) |
RGN-259 |
Tbeta4 preservative-free eye drops |
Severe dry eye |
Phase II data showed it was safe and well tolerated |
6/21/12 |
Vertex Pharmaceuticals Inc. (Cambridge, Mass.) |
VX-809 |
CFTR corrector |
Cystic fibrosis |
Phase II data showed the greatest improvements in lung function among those receiving 600 mg of VX-809 |
6/29/12 |
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Notes: Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. The date indicated refers to the BioWorld Today issue in which the news item can be found. | |||||