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Anthera Updates Phase 3 Plans Following Results from the Phase 2b PEARL-SC Dose Ranging Study of Blisibimod
- 200mg weekly, subcutaneous, blisibimod group demonstrates favorable trends in clinical response for the anticipated phase 3 severe lupus patient population - EMA validates development pathway for blisibimod
HAYWARD, Calif., June 27, 2012 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced results from the Phase 2b PEARL-SC clinical study in patients with systemic lupus erythematosus.

The purpose of the PEARL-SC study was to identify an effective and safe dose for future phase 3 clinical studies and explore key inclusion criteria and clinical endpoints in an effort to maximize differentiation of blisibimod from currently available therapies. The 200mg weekly subcutaneous dose of blisibimod demonstrated a strong trend in improved clinical response as early as week 16 (p= 0.14), at the primary endpoint (p=0.15) and throughout week 44 including a statistically significant improvement at week 20 versus placebo (p=0.02).

In a predefined phase 3 target population of severely ill, seropositive lupus patients, defined as SELENA-SLEDAI ≥10 and receiving background corticosteroid medication, a more pronounced effect was seen in the 200mg weekly dose group demonstrating a 13.8% treatment difference compared to placebo at 24 weeks. In this subgroup, planned for phase 3 studies, separation of clinical response occurred as early as week 8 and was also sustained through week 44. Results from the 200mg weekly group are presented in Table 1.

"The extensive data in the target severe population from our Phase 2 clinical program supports the initiation of a much smaller yet differentiated Phase 3 registration plan with the selected dose of blisibimod in patients with severe systemic lupus erythematosus. We have prospectively demonstrated for the first time the possibility for a subcutaneously administered BAFF inhibitor to be used in the treatment of a severe lupus population. The subgroup of severe patients from our Phase 2 study clearly identifies those patients most in need of therapy and most likely to benefit from our potent BAFF inhibitor blisibimod," said Paul F. Truex, Anthera's President and Chief Executive Officer. "Feedback from the EMA Scientific Advice process combined with an End of Phase 2 meeting in the third quarter will form the basis of our final phase 3 study designs."

Table 1: Response rates for 200mg weekly subcutaneous blisibimod versus placebo

Endpoint

(Subgroup)
12 Week Response

Placebo / Active
16 Week Response

Placebo / Active
20 Week Response

Placebo / Active
24 Week Response

Placebo / Active

SRI-5

(mITT*)
27.1% / 29.3%
26.8% / 34.8%
31.6% / 44.6%
35.3% / 43.5%

SRI-5

(Moderate*)
24.1% / 30.0%
29.3% / 36.0%
31.0% / 44.0%
34.5% / 48.0%

SRI-5

(Severe*)
27.7% / 37.5%
34.0% / 41.7%
36.2% / 52.1%
40.4% / 54.2%




* mITT: Lupus, SELENA/SLEDAI >6, seropositive

* Moderate Subgroup: Lupus, SELENA/SLEDAI >8, seropositive, receiving steroids

* Severe Subgroup: Lupus, SELENA/SLEDAI >10, seropositive, receiving steroids


The pre-specified primary efficacy endpoint, clinical improvement at 24 weeks in the SLE responder index for the pooled blisibimod dose groups, was not met due to a lack of clinical efficacy in the 100mg weekly and 200mg monthly dose groups. All doses of blisibimod demonstrated consistent serological response including reductions of B-cells, ds-DNA and improvements in both complement C3 and C4. Blisibimod was safe and well-tolerated at all dose levels with no meaningful imbalances in serious adverse events. A single suicide attempt and a non-fatal single tuberculosis infection were seen in the placebo group. There were seven deaths during the study - three in placebo and four blisibimod.

[fortuna924]

+87% heute ... . Morgen geht es weiter. NB bei 1,36$. Morgen wird das Gap geschlossen ...

[fortuna924]

Antwort auf Beitrag Nr.: 43.392.121 von fortuna924 am 16.07.12 22:06:45

hier die NEWS



/C O R R E C T I O N -- Anthera Pharmaceuticals, Inc./

In the news release, Anthera Pharmaceuticals Provides Additional Data from the Recently Completed PEARL-SC Study of Blisibimod in the Proposed Phase 3 Population, issued 16-Jul-2012 by Anthera Pharmaceuticals, Inc. over PR Newswire, we are advised by the company that in the table, sixth column, fifth row, the value should be +28.9%, rather than +22.9%, as originally issued inadvertently. The complete, corrected release follows:
Anthera Pharmaceuticals Provides Additional Data from the Recently Completed PEARL-SC Study of Blisibimod in the Proposed Phase 3 Population

HAYWARD, Calif., July 16, 2012 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced the final set of clinical data from the Phase 2b PEARL-SC study in patients with systemic lupus erythematosus.

Final data from the PEARL-SC clinical study with 200mg weekly blisibimod suggest sustained and greater treatment effects versus placebo utilizing 6, 7, and 8-point improvements in the SELENA-SLEDAI disease-scoring index (Table 1). In the predefined population of patients with severe disease who were also taking corticosteroids, the SRI-8 treatment benefit in the 200mg weekly blisibimod cohort was seen as early as week eight and achieved statistical significance starting at week 16 (35.4% blisibimod response versus 17.0% placebo response, p=0.04) through the 24 week endpoint (41.7% blisibimod response versus 10.4% placebo response, p<0.001).

Additional data regarding time to first severe flare, total flares, proteinuria, and patients achieving a reduction of steroid dose below 7.5mg per day were also positive. Amongst subjects treated with 200mg of blisibimod weekly, the mean time to first severe flare was 1.6-fold longer than subjects treated with placebo (348 days versus223 days). The reduction in proteinuria at week 24 was significantly greater amongst subjects treated with blisibimod compared to placebo (35.0% versus 5.1%, p=0.045). Further data from this recent analysis is available on the company's website at www.anthera.com. Full data from the PEARL-SC study will be presented at an upcoming scientific conference.

"These results continue to validate the importance of phase 2 studies to identify the appropriate patient, dose and endpoint in order to optimize our phase 3 study design. Specifically, the PEARL-SC SRI response using larger improvements in SELENA-SLEDAI appear substantially better than the SRI-5 data. In fact, the SRI-8 data, representing an improvement in SELENA-SLEDAI of eight points or greater achieves statistical significance at multiple time points including at 24 weeks. Due to the consistently better effects at higher thresholds, it appears that if a blisibimod patient responds, they respond very well," said Colin Hislop, MD, Anthera's Senior Vice President and Chief Medical Officer. "As well, additional clinical data suggest positive trends in time to severe flare, flare rates, proteinuria, and steroid utilization."

Table 1: 24-week response rates in subjects with severe disease (SELENA-SLEDAI >10) and Receiving Corticosteroid therapy at baseline

24-Week Endpoint*


Pooled Placebo

N=269


200 mg QW Placebo

N=92


200 mg QW blisibimod

N=92


Real Difference versus Pooled Placebo


Real Difference
versus 200mg QW Placebo

SRI-5


47.1%


40.4%


54.2%


+7.1%

p=0.48


+13.8%

p=0.18

SRI-5 + No Increase
in Steroid dose


43.5%


38.3%


52.1%


+8.6%

p=0.48


+13.8%

p=0.18

SRI-6


46.4%


38.3%


54.2%


+7.8%

p=0.43


+15.9%

p=0.12

SRI-7


28.3%


12.8%


41.7%


+13.4%

p=0.11


+28.9%

p=0.002

SRI-8


26.1%


10.6%


41.7%


+15.6%

p=0.05


+31.1%

p<0.001

*SRI is defined as patients who respond to treatment and achieve a reduction in SELENA-SLEDAI equal to or greater than the number indicated, no new BILAG A or two B organ domain scores, and no increase in Physician's Global Assessment (PGA) of greater than 0.3 on a three point scale.

On June 28, 2012, the Company announced that the 200mg weekly subcutaneous dose of blisibimod demonstrated a strong trend in improved clinical response in the modified intent to treat population as early as week 16 (p= 0.14), at the 24-week primary endpoint (p=0.15) and throughout week 44 including a statistically significant improvement at week 20 versus placebo (p=0.02). Additionally, severely ill, seropositive lupus patients, defined as SELENA-SLEDAI >10 and receiving background corticosteroid medication, a more pronounced effect was seen in the 200mg weekly dose group demonstrating a 13.8% treatment difference compared to placebo at 24 weeks.

About Blisibimod and PEARL-SC

BAFF has been associated with a wide range of B-cell-mediated autoimmune diseases, including systemic lupus erythematosus, vasculitis, IgA nephropathy, immune thrombocytopenic purpura and others. Multiple clinical studies with other BAFF antagonists recently have reported on BAFF's potential positive role in treating lupus and rheumatoid arthritis. Anthera is advancing its development of blisibimod, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. Blisibimod is a novel fusion protein called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications. The PEARL-SC Phase 2 study was designed as a randomized, double-blind, placebo-controlled, dose-ranging superiority trial to evaluate the safety, tolerability and efficacy of blisibimod plus standard of care, versus placebo plus standard of care. A total of 547 patients with active SLE were randomized to receive one of three different doses of blisibimod or placebo (100 mg weekly, 200 mg weekly or 200 mg monthly) administered subcutaneously over a minimum 24-week treatment period, in addition to standard-of-care therapy. The study was conducted at multiple centers worldwide.

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation and autoimmune diseases.

Safe Harbor Statement

Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera's public filings with the SEC, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2011 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2012. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., [e-mail] or 510.856.5586.

SOURCE Anthera Pharmaceuticals, Inc.

© 2012 PR Newswire

Diesen Artikel bookmarken bei ...

[fortuna924]

Antwort auf Beitrag Nr.: 43.392.131 von fortuna924 am 16.07.12 22:08:19

sorry link vergessen ...

http://www.finanznachrichten.de/nachrichten-2012-07/24056708…

[fortuna924]

Antwort auf Beitrag Nr.: 43.392.136 von fortuna924 am 16.07.12 22:09:23

Kursziel von 4$ ...

http://seekingalpha.com/article/723171-4-reasons-to-buy-anth…

4 Reasons To Buy Anthera Pharmaceuticals
July 16, 2012 | 5 comments | about: ANTH, includes: GSK, HGSI

Anthera Pharmaceuticals (ANTH) is a pharmaceutical company focused on the development and marketing of products to treat serious illnesses, including cardiovascular and autoimmune diseases.

Anthera's product portfolio currently consists of a potential product in Phase IIb:

- Blisibimod targets elevated levels of B-cell activating factor (BAFF), which has been associated with a variety of B-cell mediated autoimmune diseases, including systemic lupus erythematosus (SLE), rheumatoid arthritis, multiple sclerosis, Sjögren's Syndrome, Graves' Disease and others.

Based on positive results in the Phase Ia and Ib clinical studies, as well as recent validation in multiple late-stage clinical studies of the role of BAFF in lupus, the company has initiated the PEARL-SC, the Phase IIb study of Blisibimod, for the treatment of Systemic Lupus Erythematosus. PEARL-SC is a randomized, double-blind, placebo-controlled, Phase IIb clinical study that will enroll approximately 540 patients in up to 90 centers in 12 countries. Patients will be randomized into three active treatment arms and one placebo treatment arm for a minimum of 24 weeks. the primary endpoint of the PEARL-SC study is clinical improvement at 24 weeks in the SLE responder index, a recently recognized FDA endpoint for demonstrating clinical efficacy.

I find at least 4 reasons to buy the stock currently

1. Phase IIb Blisibimod results

Anthera Pharmaceutical has recently presented the results of the Phase IIb on their studies for the treatment of systemic lupus erythematosus. There was a misunderstanding in the market of these results and the shares fell to $0.6 marking a new minimum of 52 wk.

Next, a comparison among the data of Blisibimod as well as the data provided to Benlysta of Human Genome Sciences, Inc (HGSI) and GlaxoSmithKline (GSK) is established in the following charts:

Table 1: Response rates for 200mg weekly subcutaneous blisibimod versus placebo

Endpoint

(Subgroup)


12 Week Response

Placebo / Active


16 Week Response

Placebo / Active


20 Week Response

Placebo / Active


24 Week Response

Placebo / Active

SRI-5

(mITT*)


27.1% / 29.3%


26.8% / 34.8%


31.6% / 44.6%


35.3% / 43.5%

SRI-5

(Moderate*)


24.1% / 30.0%


29.3% / 36.0%


31.0% / 44.0%


34.5% / 48.0%

SRI-5

(Severe*)


27.7% / 37.5%


34.0% / 41.7%


36.2% / 52.1%


40.4% / 54.2%

* mITT: Lupus, SELENA/SLEDAI > 6, seropositive

* Moderate Subgroup: Lupus, SELENA/SLEDAI > 8, seropositive, receiving steroids

* Severe Subgroup: Lupus, SELENA/SLEDAI > 10, seropositive, receiving steroids

(Source)

Table 2: Benlysta Percentage of patients meeting Primary endpoint of SRI response at week 52


(Click to enlarge)

(Source)

The data show that the effectiveness of Blisibimod (43.5% - 48.0% - 54.2%) will be increased every 4 weeks. The studies of Benlysta® have been carried out in 52 weeks. It is assumed that the effectiveness of Blisibimod that increases every 4 weeks will be superior to Benlysta® when studies will be carried out in 52 weeks.

2. The chart mark oversold


(Click to enlarge)

(Source)

If you look at the chart we can see that Anthera is located in extreme oversold. RSI sign is in the range 28.25 and shows a clear oversold. MACD is in the time of an onset bullish symptom.

3. Insiders are buying 220,000 shares

On 29 June 2012 the President of the company Paul F. Truex bought 20,000 shares at an average price of $0.76.

The same day Christopher S. Henney's bought 200,000 shares at an average price of $0.7493.

4. Analyst price target $4.

On 28 June 2012 the Deutsche Bank analysts reiterated the recommendation for "buy" in Anthera with a target price of $4.

On 9 July 2012 the analysts of Canaccord Genuity reiterated the recommendation to "buy" in Anthera Pharmaceutical. Its target price is $3.

ANTH Analyst Stocks Recommendations

(Source)

Conclusion:

The shares of Anthera pharmaceuticals will surely go to the range of $2.00 - $2.5 before September. As I wrote in another article the company may be of interest to pharmaceutical multinationals. I might take a small speculative position in the stock this week.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
This article was sent to 188 people who get email alerts on ANTH.

[fortuna924]

auf TH geschlossen.
Sehr guter Umsatz heute

[fortuna924]

Antwort auf Beitrag Nr.: 43.392.163 von fortuna924 am 16.07.12 22:16:39

Pharmaaktien laufen z.Z. sehr gut. Siehe Arena

[fortuna924]

Antwort auf Beitrag Nr.: 43.392.184 von fortuna924 am 16.07.12 22:22:07

44 Mill. Cash und Pase 3

[fortuna924]

Antwort auf Beitrag Nr.: 43.392.196 von fortuna924 am 16.07.12 22:26:26

NB schon bei 1,42$

[fortuna924]

VB bid bei 1,34$

[weed37]

gefällt mir recht gut

Einfaches Einfügen von wallstreetONLINE Charts: So funktionierts.

[weed37]

bei bei Bruch der 0,80$ könnte hier mehr drin sein.

[weed37]

[weed37]

http://seekingalpha.com/article/1127531-anthera-shifts-its-s…

[asuro78]

Anthera Announces Data from the Phase 2b PEARL-SC Study Will Be Presented at the 10th International Congress on Systemic Lupus Erythematosus
Press Release: Anthera Pharmaceuticals, Inc. – 50 minutes ago
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ANTH 0.63

HAYWARD, Calif., March 22, 2013 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced its abstract entitled "Blisibimod, an Emerging Subcutaneous Biologic Therapy for Patients with Active, Moderate-to-Severe Systemic Lupus Erythematosus," has been selected as an oral presentation and will be presented at the 10th International Congress on Systemic Lupus Erythematosus by Dr. Morton Scheinberg, a rheumatologist at the Hospital Abreu Sodre Pesquisa Clinica in Sao Paulo, Brazil, on April 20, 2013.
Additionally, a poster entitled "Clinical Experience in Latin America With Blisibimod Amongst Subjects with Active, Moderate-to-Severe Systemic Lupus Erythematosus: Data From The Phase 2b PEARL-SC Study," will be presented by Dr. Scheinberg as part of the conferences Guided Poster Tours on April 19, 2013.
The poster will be available on www.anthera.com.
About Blisibimod and PEARL-SC
BAFF has been associated with a wide range of B-cell-mediated autoimmune diseases, including systemic lupus erythematosus, vasculitis, IgA nephropathy, immune thrombocytopenic purpura and others. Multiple clinical studies with other BAFF antagonists recently have reported on BAFF inhibitors potential positive role in treating lupus and rheumatoid arthritis. Anthera is advancing its development of blisibimod, a selective inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. Blisibimod is a novel fusion protein called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications. The PEARL-SC Phase 2 study was designed as a randomized, double-blind, placebo-controlled, dose-ranging trial to evaluate the safety, tolerability and efficacy of blisibimod plus standard of care, versus placebo plus standard of care. A total of 547 patients with active SLE were randomized to receive one of three different doses of blisibimod or placebo (100 mg weekly, 200 mg weekly or 200 mg monthly) administered subcutaneously over a minimum 24-week treatment period, in addition to standard-of-care therapy. The study was conducted at multiple centers worldwide.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation and autoimmune diseases.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera's public filings with the SEC, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2011 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., [e-mail] or 510.856.5586.

[asuro78]

Nachbörslich News Phase 3 !


Anthera Initiates CHABLIS-SC1 Phase 3 Clinical Study in Lupus with Blisibimod
Press Release: Anthera Pharmaceuticals, Inc. – 10 hours ago
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ANTH 0.64 -0.01

HAYWARD, Calif., March 27, 2013 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced it has initiated the CHABLIS-SC1 Phase 3 study of blisibimod, a novel inhibitor of B-Cell Activating Factor (BAFF) for the treatment of systemic lupus erythematosus (lupus). Lupus is a chronic autoimmune disease, which often leads to severe skin rash, fatigue, joint pain and major organ complications.
The Phase 3 CHABLIS-SC1 study is a multicenter, placebo-controlled, randomized, double-blind study designed to evaluate the efficacy, safety, tolerability and immunogenicity of blisibimod in patients with clinically active SLE (SELENA-SLEDAI > 10) who have not achieved optimal resolution of their disease with corticosteroid use. The study will enroll patients from Latin America, Asia Pacific and Commonwealth of Independent States who will be randomized to receive blisibimod or placebo for 52 weeks after which they will have the option to receive blisibimod therapy in an open-label, long-term, follow-up safety study. The study will enroll approximately 400 patients and the primary endpoint will be a Systemic Lupus Erythematosus Response Index-8 (SRI-8). An SRI-8 responder is defined as a patient who has achieved a reduction in SELENA-SLEDAI equal to or greater than 8 points, and no new BILAG A or two B organ domain scores, and no increase in Physician's Global Assessment (PGA) of greater than 0.3 on a three point scale. As part of the CHABLIS-SC1 clinical study an independent statistician will conduct interim analyses to validate key study assumptions. A summary of these analyses will be published later in 2013.
The design of the CHABLIS-SC1 study is predicated on a prospective subgroup analysis conducted in the Phase 2b PEARL-SC study, which was reported in July 2012. In this analysis, a significant improvement in SRI-8 was observed in patients who received subcutaneous blisibimod (200mg QW) compared to those treated standard steroid therapy (N=95, 41.7% versus 10.4% respectively, p
"The initiation of the CHABLIS-SC1 study marks a critical milestone for Anthera. The insight from our Phase 2b clinical study supports our belief that blisibimod may be a highly effective treatment option for the more severely ill lupus patients compared to currently available therapeutics," said Colin Hislop, MD, Anthera's Chief Medical Officer. "We are excited to advance blisibimod's development. Today we have taken another step towards making a much needed treatment available for this unpredictable and devastating disease."
About B-Cell Activating Factor (BAFF) and blisibimod
BAFF has been associated with a wide range of B-cell-mediated autoimmune diseases, including systemic lupus erythematosus, IgA nephropathy, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjogren's Syndrome, Graves' Disease and others. Multiple clinical studies with other BAFF antagonists recently have reported on the potential positive role on BAFF inhibitors in treating lupus and rheumatoid arthritis with concomitant decreases in B-cells, plasma cells and autoantibodies. Anthera is advancing its development of blisibimod, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. Blisibimod is a novel protein compromised of high-affinity BAFF binding domains fused to a human Fc domain, called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation and autoimmune disorders.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera's public filings with the SEC, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2012. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., [e-mail] or 510.856.5586.

[asuro78]

Anthera Pharmaceuticals, Inc. After Hours Trading
$.70
*
0.06

9.37%


Read more: http://www.nasdaq.com/symbol/anth/after-hours#ixzz2OosijqTw

[asuro78]

Shares Short (as of Mar 15, 2013)3: 9.13M

[asuro78]

-SC Phase 2 Clinical Study
Anthera Announces Initiation of BRIGHT-SC Phase 2 Clinical Study in IgA Nephropathy with Blisibimod
By PR Newswire, June 24, 2013, 08:30:00 AM EDT
Vote up

HAYWARD, Calif., June 24, 2013 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with autoimmune disorders, today announced it has initiated the BRIGHT-SC Phase 2 study of blisibimod, a novel inhibitor of B-Cell Activating Factor (BAFF) for the treatment of IgA nephropathy. IgA nephropathy is a chronic autoimmune renal disease characterized by proteinuria and progression to end stage renal disease.
BRIGHT-SC is a multicenter, placebo-controlled, double-blind, Phase 2 clinical study that is expected to enroll at least 48 patients from Asia Pacific geographies. Patients will be randomized into one active treatment arm or one placebo arm. The primary endpoint of the study will be a reduction in proteinuria at 32 weeks. The Company plans to conduct an interim analysis of proteinuria after patients have completed 8 weeks of therapy. Secondary endpoints will include the effects of blisibimod on estimated Glomerular Filtration Rate (eGFR), plasma B cells, and other biomarkers of kidney disease.
In May, the company met with the US FDA to discuss the future of the IgA nephropathy development plan. "We are encouraged by the outcome of our pre-Investigational New Drug meeting with the FDA. The use of proteinuria as a primary endpoint in studies of IgA nephropathy was well received by the agency," said Paula Adams, PhD, Anthera's Vice President of Regulatory Affairs and Compliance. "Data from the BRIGHT-SC study design will be helpful in our efforts to obtain an accelerated approval for blisibimod in this potential orphan indication." In the coming weeks the Company will be meeting with the Japanese Pharmaceutical Medical Devices Agency to explore development strategies in Japan.
About B-Cell Activating Factor (BAFF) and Blisibimod Less

[zwitscherton]

Anthera Pharmaceuticals Announces 1-for-8 Reverse Split of Stock
http://finance.yahoo.com/news/anthera-pharmaceuticals-announ…

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