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AEterna Zentaris, Incorporated

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AEterna Zentaris Completes Patient Recruitment for Second Efficacy Trial of its Phase 3 Program with Cetrorelix in Benign Prostatic Hyperplasia

www.prnewswire.com

This second efficacy study involves approximately 400 patients, mainly in Europe. "We are very pleased to have completed patient recruitment for this second efficacy trial as scheduled.

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/10-01-2008/0004895524&EDATE=

AEterna Zentaris Announces Appointment of as New President and CEO

www.biospace.com | Aug 13, 2008

QUEBEC CITY, Aug. 12 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. , a global biopharmaceutical company focused on endocrinology and oncology, announced today the appointment of Prof. Jurgen Engel, Ph.D. as its new President and CEO, effective as of September 1, 2008. Prof. Engel is currently

http://www.biospace.com/news_story.aspx?StoryID=106756&full=1

AEterna Zentaris Reports First Quarter 2008 Financial and Operating Results

www.topix.net | May 11, 2008

<p> All amounts are in U.S. dollars QUEBEC CITY, May 7 /CNW Telbec/ - AEterna Zentaris Inc. <a target="_blank" href="http://www.topix.net/r/07lUe3DDGoDdEToce6O4L2ekwgcDTF0Wed3X1wrn5mZRrMb5y6vjRk7a4vEyaxLsXNp=2FR=2BaRI8jyTgKAWXlbupU6qaUfL6kkxSQeyhXN4l=2B7aPR36Z9zkPSdOPm44sn3O"

http://www.topix.net/business/agriculture/2008/05/aeterna-zentaris-reports-first-quarter-2008-financial-and-operating-results

Spectrum Pharmaceuticals Provides an Update on Ozarelix in BPH

www.smartbrief.com | Apr 22, 2008

The primary endpoint of the study was the change in International Prostate Symptom Score (IPSS), the standard method of assessing BPH symptoms. Secondary endpoints included measurements in Peak Urine Flow (Qmax), Erectile Function, Quality of Life measures as well as safety and tolerability.

http://www.smartbrief.com/news/AIA/industryBW-detail.jsp?id=E0606F7A-8667-4D8F-BA62-2BD899A386B9&sb_code=RSS&i=Aerospace%20%26%20Defense%20Parts%20Manufacturing

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AEterna Zentaris Inc. - Analyst News | newratings.com

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http://www.newratings.com/headlines/AEterna-Zentaris-Inc-_CA0079752048.html

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http://www.biospace.net/company_profile.aspx?CompanyId=1672

Pharmacy Choice - Pharmaceutical News - AEterna Zentaris officials report on new developments -

AEterna Zentaris' shareholders of record as of the close of business on November 14, 2006 will be entitled to receive notice of and vote at the Special Meeting of Shareholders to be held on December 15, 2006.

http://www.pharmacychoice.com/News/article.cfm?Article_ID=43388

CNW Telbec

Les actionnaires d'AEterna Zentaris approuvent la réduction du capital déclaré et la distribution des actions restantes des Biotechnologies Atrium Inc.

http://www.cnw.ca/langLink.cgi?lang=1&url=/fr/releases/orgDisplay.cgi?okey=60682

 

AEterna Zentaris to Present at BioContact Quebec on October 2, 2008 - Zibb.com

AEterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that its President and CEO, Jürgen Engel, PhD, will present a company overview at BioContact Quebec on Thursday, October 2, 2008, at 2:00 pm (eastern time) in the Salle Frontenac of the Fairmont Le Chateau Frontenac hotel in Quebec City, Canada.

About AEterna Zentaris Inc.

AEterna Zentaris Inc. is global biopharmaceutical company focused on endocrine therapy and oncology with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at www.aezsinc.com.

SOURCE AETERNA ZENTARIS INC.

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Tags: ceo   hotel   nasdaq   president   quebec  

Companies: AEterna Zentaris Inc (AEZ), AEterna Zentaris Inc (AEZS), Le Chateau Inc. (LCUAF)

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AEterna Zentaris Completes Patient Recruitment for Second Efficacy Trial of its Phase 3 Program

AEterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and oncology, today reported the completion of patient recruitment for the Company's second efficacy trial of its Phase 3 program in benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate, with its flagship product candidate, cetrorelix, a Luteinizing Hormone Releasing Hormone (LHRH) antagonist. This second efficacy study involves approximately 400 patients, mainly in Europe.

"We are very pleased to have completed patient recruitment for this second efficacy trial as scheduled. Our Phase 3 program is progressing well and remains on track with first results expected for the third quarter of 2009," said Paul Blake MD, Senior Vice President and Chief Medical Officer of AEterna Zentaris. "We firmly believe that cetrorelix's novel therapeutic approach could lead to a more efficacious and convenient treatment for the millions of men with BPH."

The study, titled, "Cetrorelix pamoate in patients with symptomatic BPH: a double-blind, placebo-controlled efficacy study", involves approximately 400 patients, and will assess an intermittent dosage regimen of cetrorelix as a potential safe and tolerable treatment providing prolonged improvement in BPH-related signs and symptoms. This Phase 3 trial, conducted in Europe under the supervision of lead investigator, Prof. Dr. Frans M.J. Debruyne, MD, of the Andros Mannenkliniek, Arnhem, The Netherlands, is part of the Company's Phase 3 program with cetrorelix being studied in approximately 1,500 patients in North America and Europe in men with symptomatic BPH.

About the Phase 3 Program with Cetrorelix in BPH

The first multi-center efficacy study for which patient recruitment was completed in April 2008, is currently being conducted primarily in the United States and Canada, with additional sites in Europe and involves approximately 600 patients under the supervision of lead investigator, Herbert Lepor, MD, Professor at NY University School of Medicine, New York. Patients enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS). Patients are then randomly allocated to cetrorelix or placebo in a double-blind fashion. Patients are administered cetrorelix by intra-muscular (IM) injection at Week 0, 2, 26 and 28 and are followed up to Week 52. Then, in an open-label extension, patients receive cetrorelix by IM injection at Week 52, 54, 78 and 80 and are followed up to Week 90.

The second multi-center Phase 3 efficacy study for which patient recruitment completion was announced today, involves approximately 400 patients, mainly in Europe. Patients in this randomized placebo-controlled study with open-label extension, receive cetrorelix according to similar dosing regimens used in the first study.

The primary endpoint for both North American and European efficacy studies is absolute change in IPSS between baseline and Week 52. Other efficacy endpoints include additional measures of BPH symptom progression and the need for BPH-related surgery. Safety endpoints include changes in sexual function. Other important endpoints include plasma changes in levels of testosterone, and assessment of other adverse events.

The third study in the Phase 3 program, a multi-center safety study, for which patient recruitment started in May 2008, is an ongoing open-label, single-armed study involving approximately 500 patients in both North America and Europe.

About Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (BPH) is one of the most common diseases of aging men - affecting more than 20 million men in the United States - but its etiology is far from being completely understood. Data from ongoing research suggest BPH and lower urinary tract symptoms (LUTS) are more complex conditions than once thought. While previous research on BPH etiology tended to focus on testosterone and other hormones, more recent research suggests other factors - including inflammation, various growth factors, and adrenoreceptors - actually may play a greater role in the development of BPH and LUTS.

BPH is associated with LUTS, including: frequent urination, a sudden, uncontrollable urge to urinate, waking at night to urinate (nocturia), difficulty starting a urine stream (hesitancy and straining), decreased strength of the urine stream (weak flow), feeling that the bladder is not completely empty, an urge to urinate again soon after urinating and pain during urination (dysuria). Currently available therapies may improve symptoms to some degree, but often come with sexual and other side effects.

About Cetrorelix

Cetrorelix pamoate is an investigational agent that has shown in Phase 2 studies to provide fast and long lasting relief of BPH symptoms and was well tolerated, with a low incidence of sexual side effects. Cetrorelix is part of AEterna Zentaris' Luteinizing Hormone Releasing Hormone (LHRH) antagonist therapeutic approach. This peptide-based active substance was developed by the Company in cooperation with Nobel Prize winner Prof. Andrew Schally, currently of the U.S. Veterans Administration in Miami.

Cetrorelix acetate is marketed under the brand name Cetrotide(R), the first LHRH antagonist approved for therapeutic use as part of in vitro fertilization programs (controlled ovulation stimulation/assisted reproductive technologies) in Europe, the USA and Japan. It was launched on the market through Serono (now Merck Serono) in the U.S., Europe and in several other countries, as well as in Japan through Shionogi.

In addition to the Phase 3 program in BPH, cetrorelix is also being studied in a Phase 2b program in this same indication in Japan, sponsored by the Company's partner, Shionogi.

About AEterna Zentaris Inc.

AEterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology, with proven expertise in drug discovery, development and commercialization.

News releases and additional information are available at www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments except if we are requested by a governmental authority or applicable law.

SOURCE AETERNA ZENTARIS INC.

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Tags: business   canada   clinical   europe   fashion   health   japan   law   medicine   men   nasdaq   new_york   north america   president   research   securities   surgery   technology   track   trial   university   veterans  

Companies: AEterna Zentaris Inc (AEZ), AEterna Zentaris Inc (AEZS)

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AEterna Zentaris to Announce Second Quarter 2008 Financial and Operating Results on August 12, 2008

AEterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and oncology, will announce its second quarter 2008 financial and operating results after market close on Tuesday, August 12, 2008. The Company will host a conference call and webcast to discuss these results later that same day at 4:30 p.m., Eastern Time.

Participants may access the conference call by dialing the following numbers: 416-644-3430, 514-807-8791 or 800-814-4862. They may also access the live webcast via the Company's website at www.aezsinc.com in the "Investors" section. A replay of the webcast will also be available on the Company's website for a period of 30 days.

About AEterna Zentaris Inc.

AEterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at www.aezsinc.com.

SOURCE AETERNA ZENTARIS INC.

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Tags: conference   market   nasdaq  

Companies: AEterna Zentaris Inc (AEZ), AEterna Zentaris Inc (AEZS)

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MethylGene to Present at Investor Conferences - Zibb.com

MethylGene Inc. (TSX: MYG) today announced that Donald F. Corcoran, President and Chief Executive Officer, will present at two upcoming investor conferences, one sponsored by BMO Capital Markets and the other by Canaccord Adams.

Mr. Corcoran will present at the BMO Capital Markets' 8th Annual Focus on Healthcare Conference in New York on Tuesday, August 5th at 9:30 a.m. EDT. Mr. Corcoran will also present at the 28th Annual Canaccord Adams Global Growth Conference in Boston on Wednesday, August 13th at 2:30 p.m. EDT.

Both presentations will be available via live webcast on MethylGene's website at www.methylgene.com.

About MethylGene

MethylGene Inc. (TSX: MYG) is a publicly-traded, clinical stage, biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer. The Company's clinical-stage oncology products include lead compound, MGCD0103, an oral, isoform-selective HDAC inhibitor and MGCD265, an oral, multi-targeted kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. In addition, MethylGene's preclinical programs include: MGCD290, an HDAC inhibitor used in combination with azoles for fungal infections, a kinase inhibitor program for ocular diseases, and a sirtuin inhibitor program for cancer. MethylGene's development and commercialization partners include Celgene Corporation, Taiho Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd. and EnVivo Pharmaceuticals. Please visit our website at www.methylgene.com.

Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management of MethylGene, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond MethylGene's control. These risks and uncertainties could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such results, performance or achievements include, but are not limited to, the timing and effects of regulatory action; the continuation of collaborations; the results of clinical trials; the timing of enrollment or completion of clinical trials; the success, efficacy or safety of MGCD0103, MGCD265 or MGCD290; the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD0103, MGCD265 or MGCD290, and the relative success or the lack of success in developing and gaining regulatory approval and/or market acceptance for any compound or new product including MGCD0103, MGCD265 or MGCD290. Such risks include, but are not limited to, the impact of general economic conditions, economic conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which MethylGene does business, stock market volatility, fluctuations in costs, expectations with respect to our intellectual property position and our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others, changes in the competitive landscape including changes in the standard of care for the various indications in which MethylGene is involved, and changes to the competitive environment due to consolidation, as well as other risks, which you are urged to read, as described in MethylGene's Annual Information Form for the fiscal year ending December 31, 2007, under the heading 'risk factors,', and all other documents filed by the Company that can be found at www.sedar.com. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance on the forward-looking statements included in this presentation. These statements speak only as an update on the date they are made and MethylGene is under no obligation to revise such statements as a result of any event, circumstance or otherwise except in accordance with law.

Contacts:
Rx Communications Group, LLC
Rhonda Chiger
Investor Relations
917-322-2569
rchiger@rxir.com

MethylGene Inc.
Donald F. Corcoran
President & CEO
514-337-3333 ext. 373
mctavishk@methylgene.com


SOURCE: MethylGene Inc.

mailto:rchiger@rxir.com
mailto:mctavishk@methylgene.com

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Tags: business   cancer   ceo   clinical   communications   conference   environment   healthcare   infection   law   manufacturer   market   new_york   new product   pharmaceuticals   president   products   property  

Companies: Methylgene Inc (MYG), Methylgene Inc (MYLGF)

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