Once we've got the Phase IIb data in atopic dermatitis we have enough data to do the Phase III, but the issue we will have to look at is finance," Forster noted

Christensen said Dyax will start looking at the international markets "on the back of the Phase IIb data

Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) DAC HYP A daclizumab high-yield process Multiple sclerosis Phase IIb data showed it reduced the annualized relapsed rate by 54%, meeting the study's primary endpoint 4/5/13 Fibrocell Science Inc. (Exton, Pa.) LaViv Autologous fibroblast injection azficel-T Moderate-to-severe acne scars Phase II study demonstrated that azficel-T treatment was associated with clinically meaningful improvement

direct-acting antivirals Hepatitis C virus genotype 1 Phase IIb data showed greater than 90% sustained viral response rates 4/24/13 Achillion Pharmaceuticals Inc. (New Haven, Conn.) ACH-3102 Pan-genotypic NS5A inhibitor Hepatitis C virus genotype 1 Phase II data showed it was active against both wild-type and NS5A-resistant viral variants when used with sovaprevir 4/24/13 Boehringer Ingelheim Pharmaceuticals Inc. (unit of Boehringer Ingelheim GmbH; Ingelheim, Germany) BI 201335 Faldaprevir

Once we've got the Phase IIb data in atopic dermatitis we have enough data to do the Phase III, but the issue we will have to look at is finance," Forster noted

This was an opportunistic deal where the Phase IIb data were available in a very important indication

This was an opportunistic deal where the Phase IIb data were available in a very important indication

In Phase IIb data, drisapersen showed a statistically significant benefit to DMD patients on the six-minute walk test, serving to de-risk upcoming Phase II U.S

IIb data of it used with Truvada showed similar virologic success rates compared to Sustiva plus Truvada 3/6/13 Vertex Pharmaceuticals Inc. (Cambridge, Mass.) VX-787 New class of medicine Influenza Phase II data showed statistically significant improvements in viral and clinical measurements of infection 3/5/13 INFLAMMATORY Auxilium Pharmaceuticals Inc. (Chesterbrook, Pa.) Xiaflex Collagenase clostridium histolyticum Adhesive capsulitis Top-line Phase IIa data showed positive, statistically

the drug also met a key secondary endpoint 3/22/13 Biotie Therapies Corp. (Turku, Finland) SYN115 Tozadenant Parkinson's disease Phase IIb data showed significant reductions in mean placebo-corrected change from baseline in "off" time were observed with tozadenant 120 mg BID and 180 mg BID 3/22/13 BrainStorm Cell Therapeutics Inc. (New York) NurOwn Technology for the propagation and differentiation of autologous mesenchymal stem cells into nuerotrophic factor-secreting cells Amyotrophic lateral

IIb data in-house by midyear

Sarepta (formerly AVI BioPharma Inc.) wowed the market last year with Phase IIb data on exon-skipper eteplirsen. (See BioWorld Today, July 25, 2012, and Oct. 4, 2012.) PTC Therapeutics Inc., of South Plainfield, N.J., has, perhaps, the most advanced Becker MD candidate with ataluren, which also has shown clinically meaningful trends in DMD and cystic fibrosis

The company began considering an initial public offering (IPO) or regional licensing transaction, based on the Phase IIb data

We have been highlighting the risks to the CLI study, despite the positive randomized Phase IIb data in hand, and it now appears that the enrollment issues became insurmountable," wrote Roth Capital Partners analyst Joseph Pantginis, who assessed Aastrom's risk profile as "much heightened

IIb data showed a single dose was not sufficient 2/5/13 Inviragen Inc. (Fort Collins, Colo.) DENVax Dengue vaccine Dengue Started the second stage of its ongoing phase II study 2/28/13 RESPIRATORY Circassia Ltd. (Oxford, UK) ToleroMune T-cell vaccine Cat allergy Phase II data showed a short course of four doses maintained improvements in patient symptoms two years after the start of treatment 2/26/13 MISCELLANEOUS Amicus Therapeutics Inc. (Cranbury, N.J.) Migalastat HCl Single oral dose Fabry

Ltd. (Osaka, Japan) OCA Obeticholic acid Nonalcoholic steatohepatitis Began a Phase II trial 1/9/13 Tobira Therapeutics Inc. (South San Francisco) Cenicriviroc An oral, once-daily CCR5/CCR2 inhibitor HIV Phase IIb data showed it met the primary objective 1/8/13 INFLAMMATORY Receptos Inc. (San Diego) RPC1063 Selective sphingosine1 phosphate 1 receptor modulator Moderately to severely active ulcerative colitis Dosed the first patient in a Phase II study 1/7/13 XOMA Corp. (Berkeley, Calif

Although Opexa's future rests on the Abili-T data, the company will need additional cash before the Phase IIb data read out, Warma acknowledged

an antibody-drug conjugate (ADC) that targets and binds to GPNMB Metastatic breast cancer Phase IIb data showed that treatment of patients with both triple-negative breast cancer and high GPNMB expression showed high overall response rates for the CDX-011 arm (CDX-011 ORR of 33% vs. 0% in the IC arm) and an overall survival and progression-free survival benefit (PFS) for CDX-011 that reached statistical significance (CDX-011 median survival of 10 months vs. IC of 5.5 months

of patients who received elotuzumab at a dose of 20 mg/kg, median PFS was 18.6 months (N = 37) and ORR was 76% 12/11/12 Celator Pharmaceuticals Inc. (Princeton, N.J.) CPX-351 A fixed-dose combination of the established cancer drugs cytarabine and daunorubicin Acute myeloid leukemia Phase Iib data showed it was highly active in all patient subgroups and had the greatest response rate in patients with secondary AML and adverse cytogenetics 12/12/12 Celgene Corp. (Summit, N.J.) CC-486 Oral