Friday, August 31, 2012

Epigenomics, Present and Future Applications for Pharmaceuticals and Diagnostics: Twease.org


ALBANY, New York,today announced that Twease.org - New Report Added in Biotechnology Reports Database Epigenomics, Present and Future Applications for Pharmaceuticals and Diagnostics

Mabs" and molecular tests are among the growth industries of pharmaceuticals and diagnostics, but they may have competition long-term from an unexpected source. Epigenomics is a potential game-changer in the clinical therapeutics market and significant in testing as well. It refers to technologies involving changes in genetic material that find their origins in causes other than base pairs alterations in the DNA of the host. 

Examples of such changes include DNA methylation and histone acetylation, both of which have been known for many years to cause changes in gene expression. This report Epigenomics, Present and Future Applications for Pharmaceuticals and Diagnostics describes the progress that has been made in our understanding of the basic science of epigenomics and considers the practical accomplishments being reported by the private sector.

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Indian Pharma MNC Piramal Investing in German Molecular Imaging Technology


BERLIN, today announced that 
Innovative medical research in Germany

In April 2012, Indian MNC Piramal took over Bayer HealthCare's molecular-imaging pipeline and has since then been continuing research and development work on the acquired PET radiopharmaceuticals in its labs in Berlin. Speaking at a press conference Mr. Ajay Piramal, Chairman of Piramal Group commented on the strategy saying, "Molecular imaging is one of the key technologies paving the way to individualized medicine. Our acquisition of a powerful pipeline in this field hence, is an important milestone on the road to an innovative pharmaceutical portfolio for us."

Florbetaben, Piramal's most advanced PET tracer, enables the detection of beta-amyloid deposits in the brain and could therefore open the door to the early diagnosis of Alzheimer's disease. "A phase III study to test the reliability of florbetaben in the histopathological detection of beta-amyloid has been successfully completed. Submission of the dossier for drug approval by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) is expected later in 2012. In addition, Piramal Imaging is working on other PET tracers for various medical indications," 
said Dr. Swati Piramal, Vice-Chairperson of Piramal Enterprises

According to Christoph von Knobelsdorff, Permanent Secretary at the Berlin Senate's Department of Economics, Technology and Research, Piramal Imaging's decision to come toBerlin is a real gain for the city as a business location, underlining its reputation as a center of knowledge-based economy. "Piramal has made a good choice with Berlin. The healthcare industry in the capital region is highly innovative and offers above-average growth potential. The density of the scientific and research institutions here is unique throughout Europe. Our policy aims to create intense links between business, research and science."

"The field of molecular imaging is made attractive by the availability of excellent technical equipment and the vicinity of renowned academic institutions, such as Charité University Hospital and the Max Delbrück Center for Molecular Medicine. This is a good environment for interdisciplinary exchange between academia and industry," confirms Professor Günter Stock, President of the Berlin-BrandenburgAcademy of Sciences and spokesperson of the network HealthCapital Berlin-Brandenburg. 

Researching novel agents to improve medical diagnostics has been a long tradition in Berlin. This is where the first commercially available X-ray contrast agent was developed - as early as 1931. Then in the late 1980sBerlin researchers developed the first contrast agent for magnetic resonance imaging (MRI), revolutionizing medical imaging.

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Sosei Group Corporation QVA149 Phase III Study Meets Primary Endpoint in Reducing Exacerbations in COPD Patients and Filings in EU and Japan by End of Year


TOKYO announced today that 
  • SPARK demonstrated QVA149 statistically significantly reduced rate of moderate-to-severe exacerbations compared to glycopyrronium 50 mcg.

  • Study showed QVA149 statistically significantly reduced overall exacerbation rates compared to glycopyrronium 50 mcg and open-label tiotropium 18 mcg

  • SPARK is the final study of the IGNITE Phase III clinical trial program intended for initial regulatory filings
Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) confirms the information released today by Novartis that results from the fifth QVA149 (indacaterol maleate / glycopyrronium bromide) Phase III study, SPARK, met its primary endpoint of a reduced rate of moderate-to-severe COPD exacerbations compared to glycopyrronium bromide (Seebri Breezhaler)

. SPARK is the final study intended for initial regulatory filings of QVA149 in Europe and Japan, which are expected in Q4 2012. US filing of QVA149 is expected at the end of 2014. To date, the first five studies of the IGNITE QVA149 Phase III clinical trials program have all met their primary endpoints of efficacy, safety, exercise endurance, and reduction of exacerbations
.
SPARK met its primary endpoint by demonstrating that patients treated with once-daily (QD) investigational QVA149 for 64 weeks demonstrated a clinically meaningful and statistically significant lower rate of moderate-to-severe COPD exacerbations compared to patients treated with QD glycopyrronium 50 mcg (p=0.038)[1]. The study also showed that the rate of moderate-to-severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to open-label (OL) tiotropium 18 mcg.

A further analysis of the data demonstrated that QVA149 was statistically significantly more effective in reducing the overall rate of all exacerbations (mild, moderate and severe) compared to glycopyrronium 50 mcg (p=0.001) and OL tiotropium 18 mcg (p=0.002). The adverse event (AE) profile of QVA149 was similar to both glycopyrronium 50 mcg and OL tiotropium 18 mcg.

The management of COPD exacerbations is important to both patients and physicians, as exacerbations can impose a significant burden of morbidity, mortality, reduced quality of life and healthcare costs. Frequent exacerbations are linked to an accelerated decline in lung function and patients are also known to have a poorer quality of life. Admissions to hospital due to exacerbations are increasing and patients with more severe underlying disease account for around 70% of the direct medical costs of COPD.

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Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab


HORSHAM, Pa.- Janssen Biotech, Inc. ("Janssen"), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that it has executed a global license and development agreement with the Danish company Genmab A/S for the anti-cancer compound, daratumumab.  Daratumumab (HuMax-CD38) is a human CD38 monoclonal antibody currently in Phase I/II studies in relapsed, refractory multiple myeloma. 

"Janssen was one of the first companies to recognize the power and promise of monoclonal antibodies and today is a world leader in biologics.  We look forward to applying that same expertise to daratumumab to help meet the needs of patients with multiple myeloma," said William N. Hait, M.D., Ph.D., head of Janssen Research & Development, LLC.  "Daratumumab is an exciting, innovative compound, and we are delighted to add it to our portfolio."

Under terms of the agreement, Genmab will grant Janssen an exclusive worldwide license to develop and commercialize daratumumab as well as a back-up CD38 human antibody.  Janssen has made an upfront payment and will make additional payments based upon the achievement of certain development, regulatory and sales milestones.  Genmab will be responsible for completing the GEN501 and GEN503 Phase I/II trials.  Janssen will be responsible for all other development, clinical and regulatory filing activities.  In addition, as part of the agreement, Johnson & Johnson Development Corporation, an affiliate of Janssen, will make an equity investment in Genmab.

The transaction is subject to customary closing conditions, including approval by the Danish Financial Supervisory Authority and clearance by the U.S. antitrust authorities.

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Eaton Scientific Retains Clinical Trial Veteran Dr. David Stark to Develop and Oversee FDA Compliant Trials of Tropine 3 for Non-Hormonal Treatment of Hot Flashes in Menopausal Women


BEVERLY HILLS, Calif., today announced that -- Eaton Scientific Systems, Ltd. ("Eaton Scientific" or the "Company"), a wholly owned subsidiary of Pristine Solutions, Inc. (OTCQB: PRTN) is pleased to announce that the Company has retained clinical trial veteran Dr. David L. Stark, D.C., Q.M.E., CCRA, to develop and oversee FDA compliant trials of Tropine 3 for non-hormonal treatment of hot flashes in menopausal women. 

"The addition of Dr. Stark to the Eaton Scientific team gives a significant boost to our efforts to develop, validate, and monetize Tropine 3 as a safe and effective non-hormonal treatment of hot flashes in menopausal women," stated Michael Borkowski, CEO and President of Eaton Scientific.   "We except that he will be instrumental in all aspects of our planned clinical trials going forward especially in regard to trial development, implementation, and overall FDA compliance."

Dr. Stark has over 18 years of experience from the toxicology labs to the investigator site and has been essential in all aspects clinical and device research.  Dr. Stark is currently the President and CEO of Stark-SMO, a Site Management Organization whose services go far beyond that of an ordinary SMO.  Through Dr. Stark's diverse and devoted networking within the industry, Stark-SMO has assembled a wide network of more than 5,000 physicians throughout the United States, which extends to the international community. 

Formerly the Director of the National Institute of Clinical Research (NICR), he has been responsible for the design, organization and implementation of clinical trials for numerous pharmaceutical and device companies.  Dr. Stark is one of the few individuals in the sector that has worked in the manufacturing validation of pharmaceuticals, the clinical field, and the regulatory (IRB) arenas, and therefore possesses a big-picture understanding of pharmaceutical development.

Due to his extensive and broad experiences in the inner workings of the research and regulatory aspects of clinical trials, Dr. Stark brings a unique vision to the industry and the Company as a motivated designer of superior approaches to research challenges.  Most importantly, Dr. Stark is highly qualified to manage the development opportunities of the Company.

In addition to his significant accomplishments on the industry side of clinical drug and device development, Dr. Stark has experience with the FDA with a major focus on Investigational New Drugs (IND), New Drug Applications (NDA), and 510K applications.  Prior to his employment at NICR, Dr. Stark was the President and Chief Executive Officer of Powder Ice, a medical products company.  Additionally, Dr. Stark is a California state licensed Qualified Medical Examiner and Certified Clinical Research Associate.

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New Virginia G. Piper Cancer Center-TGen study targets non-small cell lung cancer


SCOTTSDALE, Ariz. today announced that - A Phase I/II, multi-center trial designed to test the safety and preliminary efficacy of a first-in-class cancer treatment opened worldwide today at the Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).

PR610 is designed to become activated in tissues with low levels of oxygen, which is characteristic of many cancers. This "targeted" approach should deliver more active drug to cancer tissue and less active drug to normal tissue.

The two-part trial, sponsored by the drug's manufacturer, Proacta, Inc., will first determine acceptable dose levels of PR610 in patients with various types of advanced cancer. After determining acceptable dose levels, the study will evaluate the safety and efficacy of PR610 when given to patients with non-small cell lung cancer whose tumors contain a certain genetic mutation. Other goals of the study are to measure levels of PR610 in the blood.

"PR610 is a promising and innovative compound that merges delivery of a drug to the cancerous, oxygen depleted tissue and it also targets the communication functions that govern the growth and behavior that drive certain cancers," said Dr. Glen Weiss, director of Thoracic Oncology at Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare and clinical associate professor at TGen.

Research has shown that some cancer tissue has lower levels of oxygen than normal tissue. This lower level of oxygen appears to make the cancer tissue more resistant to radiation and chemotherapy, which allows the cancer to become more aggressive and spread. PR610 is designed to become active in cancer tissue with low levels of oxygen.

"Proacta is very excited to be working with Virginia G. Piper Cancer Center Clinical Trials and TGen on this important study. We purposely limited participation in this study to those cancer centers with extensive experience and expertise in conducting clinical oncology trials," said Dr. John Gutheil, CEO of Proacta.

Non-small cell lung cancer is a disease in which cancerous cells form in the tissues of the lung. There are several types, and chances of recovery are determined by many factors, such as smoking and lifestyle. Unfortunately, current treatments options do not cure the majority of patients with non-small cell lung cancer.

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SureGene and PGXL Laboratories launch the SureGene Test for Antipsychotic and Antidepressant Response (STA2R)


 
LOUISVILLE, Ky., today announced that - SureGene announced today that it has partnered with PGXL Laboratories, a CLIA-certified lab in Louisville, KY., to launch the SureGene Test for Antipsychotic and Antidepressant Response (STA2R), a breakthrough pharmacogenetic test containing genetic markers for effectiveness of antipsychotic drug treatment.  STA2R provides clinicians with valuable new information to facilitate personalized antipsychotic and antidepressant drug selection.

Millions of people each year are treated with antipsychotic drugs, and tens of millions are treated with antidepressants.  Very often, patients must try several drugs before finding the right one for them.  With the STA2R report, for the first time clinicians have useful medical information to augment their experience for selecting a drug treatment for each patient.

STA2R combines the propriety SULT4A1-1 genetic signature with four other gene tests. Clinical studies in Caucasian schizophrenic patients have indicated that SULT4A1-1 positive patients treated with olanzapine have greater reduction in psychotic symptoms and a significantly lower risk of being hospitalized.  Additionally STA2R helps identify those patients for whom risperidone, the current standard treatment, is contraindicated and patients that may not respond as well to certain antidepressants.

"STA2R represents a revolutionary change to the treatment of schizophrenia and bipolar disorder.  For the first time, physicians will have a test that can help them prioritize the treatment choices for their patients," say Dr. Bill W. Massey, President of SureGene.

STA2R has an easy collection process requiring only a simple cheek swab in the healthcare professional's office.  The swabs are then placed in the pre-paid shipping container, which is then delivered to PGXL Laboratories, a CLIA-certified lab in Louisville, KY.  Within a few days, the clinician receives a secure report.

SureGene discovered and patented the SULT4A1 genetic signature.  PGXL Laboratories independently developed the STA2R test and will exclusively perform the test in its laboratory.  SureGene is working with healthcare providers to promote the test.

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Metabolic Solutions Development Company to present at the Benzon Symposium No. 58 on Adipose Tissue in Health and Disease


KALAMAZOO, Mich.,today announced that -- Researchers at Metabolic Solutions Development Company, LLC (MSDC) have identified a mitochondrial protein complex through which insulin sensitizers achieve their anti-diabetic effects. Findings from this research are being presented August 30 at the Benzon Symposium No. 58 in Copenhagen, Denmark.

The newly identified mitochondrial target is being referred to as the mitochondrial Target of Thiazolidinediones, or mTOT. Key proteins in this complex include Mpc2 (BRP44) and Mpc1 (BRP44-Like), which have recently been shown to function as the mitochondrial pyruvate carrier.

The mTOT complex functions as a molecular "sensor switch" connecting mitochondrial metabolism to important cellular activities, such as carbohydrate and lipid metabolism, that are out of balance in patients with type 2 diabetes. Activation of mTOT increases cell differentiation and favors fat oxidation, resulting in increased insulin sensitivity, generation of brown fat and preservation of pancreatic beta cells.

"Identification of this new mitochondrial target, and understanding its role in metabolic signaling, has enabled a new approach to developing the next generation insulin sensitizers for the treatment of type 2 diabetes," said Rolf Kletzein, PhD, MSDC's co-founder and senior vice president of research.

Using a novel drug analog photo-catalyzable affinity probe and mass spectrometry-based proteomics, MSDC scientists identified two phylogenetically-conserved proteins in the inner mitochondrial membrane, Mpc2 (BRP44) and Mpc1 (BRP44-Like). These proteins are present in, and play an important role in the development of organisms from yeast and fruit flies to humans. Proof ofidentity has been demonstrated by gene expression and knockdown of expression. 

MSDC's discovery suggests the lowering of plasma glucose can be achieved without having to activate the nuclear receptor PPARg. Previously, it was believed that both the activity and the side-effects of the only approved agents used to treat insulin resistance -- the core problem for persons diagnosed with type 2 diabetes -- were mediated through PPARg. However, it is now generally accepted that over-activation of this transcription factor drives the unwanted and often unacceptable side effects associated with the currently approved anti-diabetic insulin sensitizers, which are PPARg agonists.

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Novation Supports New Development in the U.S. Biosimilar Pharmaceuticals Market


IRVING, Texas today announced that -- Novation applauds the recent approval by the U.S. Food and Drug Administration of Sicor Biotech's tbo-filgrastim and the important milestone it represents in the continued development of biosimilar pharmaceuticals in the United States. Although approved through a full Biologics License Application and not a formal "biosimilar", this product is expected to fill the same role in clinical practice as subsequent biosimilars that are ultimately approved via the abbreviated pathway, signed into law in 2010. Sicor Biotech is expected to begin marketing tbo-filgrastim in November 2013.  
Biosimilars, which are 'highly similar' versions of reference biologics, are currently approved for use in the European Union and other regions. Research suggests that use of biosimilars could result in price decreases of 20 to 30 percent.
"Despite the slower pace of development in the U.S., biosimilars represent a much needed opportunity for lower-cost alternatives to commonly used biologics as hospitals struggle to contain drug related expenditures," said Steven Lucio, PharmD, BCPS, director of clinical solutions, pharmacy, Novation. "Both this product and subsequently approved biosimilars will require a great deal of physician, pharmacist and clinical staff education to ensure appropriate use and meaningful uptake in the US market. Novation is committed to serving as a resource to help healthcare providers prepare for biosimilars and maximize their impact."
The FDA approved Sicor's tbo-filgrastim as a treatment for patients receiving cancer chemotherapy who experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.
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Wednesday, August 29, 2012

Celladon Corporation Announces First Patient Dosed in CUPID Phase 2b Trial of MYDICAR for Advanced Heart Failure


SAN DIEGO, Aug. 29, 2012 -- Celladon Corporation, a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced today that it has dosed the first patient in a Phase 2b clinical trial of MYDICAR, Celladon's first in class therapeutic for the treatment of advanced heart failure (HF). 

Chronic HF is a leading cause of hospitalization and resulted in direct and indirect costs of $39.2 billion to the U.S. healthcare system in 2010. Nearly 6 million people in the U.S. have HF and at least 670,000 new cases are diagnosed yearly. Heart failure leads to an estimated 280,000 deaths annually. There is no cure.

The Phase 2b study titled "Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease" ("CUPID Phase 2b Trial") is a multinational, multicenter, double-blind, placebo-controlled, randomized study of a single intracoronary administration of 1 x 1013 DRP MYDICAR versus placebo added to an optimal HF regimen. 

The primary objective is to determine the efficacy of MYDICAR in patients with ischemic or dilated cardiomyopathy and NYHA class III/IV symptoms of HF by reducing the frequency and/or delaying HF-related hospitalizations compared to placebo-treated patients. Secondary objectives will include assessment of the safety of MYDICAR by determining the incidence and severity of adverse events and changes in laboratory parameters. The trial will enroll approximately 200 patients in up to 50 international sites. Results are anticipated in the first half of 2015.

The Chairman of the Executive Clinical Steering Committee of the CUPID Phase 2b Trial is  Barry H. Greenberg M.D., FACC, Director, Advanced Heart Failure Treatment Program; Professor of Medicine, University of California, San Diego. Dr. Greenberg stated, "We are enthusiastically looking forward to evaluating MYDICAR in the CUPID Phase 2b Trial for advanced heart failure. There is a major unmet need to provide safe and effective therapies for patients with advanced heart failure such as the ones who we will be studying in this trial."

"With the encouraging results from the preceding CUPID Phase 2 trial and the timely dosing of the first patient in this Phase 2b trial, we are firmly on track with our plan to develop a novel, safe, and effective therapy for patients with advanced heart failure," said Krisztina Zsebo Ph.D., President and CEO of Celladon Corp.  

The first patient was dosed at Sharp Memorial Hospital in San Diego, CA by Brian Jaski, M.D., FACC, and Scientific Director of Research at the San Diego Cardiac Center. "We are grateful to be able to collaborate with Celladon for new innovative therapies for patients with serious heart failure.  Heart failure is an increasing medical problem with no major breakthrough in medication therapy in over twenty years.  Thus, there exists a large unmet need to help these patients." noted Dr. Jaski.

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MEI Pharma CEO To Present At Stifel Nicolaus Healthcare Conference

SAN DIEGO, Aug. 29, 2012  -- MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for the treatment of cancer, announced today that Daniel P. Gold, Ph.D., President and Chief Executive Officer, will present an update on MEI Pharma and its lead oncology drug candidates, ME-143, ME-344 and Pracinostat, at the Stifel Nicolaus Healthcare Conference on Wednesday, September 5, 2012 at 3:50 p.m. 

Eastern time from the Four Seasons Hotel in Boston. A live webcast of the presentation can be accessed at www.meipharma.com/investor. A replay will be available approximately one hour after the presentation.


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Lilly Stops Phase III Development of Pomaglumetad Methionil For the Treatment of Schizophrenia Based on Efficacy Results


INDIANAPOLIS, Aug. 29, 2012 -- Eli Lilly and Company (NYSE: LLY) announced today the decision to stop ongoing clinical studies investigating pomaglumetad methionil, also known as mGlu2/3, for the treatment of patients suffering from schizophrenia. The decision was made after a recently conducted independent futility analysis concluded HBBN, the second of Lilly's two pivotal studies, was unlikely to be positive in its primary efficacy endpoint if enrolled to completion. The decision was not based on any safety signals.

Additionally, the recently completed Phase II study, HBCO, which investigated pomaglumetad methionil as an adjunctive treatment with atypical antipsychotics, did not meet its primary endpoint. 

Lilly is contacting study investigators to outline specific actions related to the close-out of each ongoing study. Lilly will work with study investigators to ensure an appropriate transition of study participants to continuing clinical care outside of the trials.

"I'm disappointed in what these results mean for patients with schizophrenia who still are searching for options to treat this terrible illness," said Jan Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories.  "While there are many challenges in this complex field of research, neuroscience remains a core area of focus at Lilly. Our clinical development pipeline includes nearly a dozen neuroscience molecules being studied to treat illnesses such as depression, bipolar disorder and cognitive impairment associated with schizophrenia."

The decision to stop ongoing Phase III development of pomaglumetad methionil is expected to result in a third-quarter charge to R&D expense in the range of $25 million to $30 million(pre-tax), or approximately $0.02 per share (after-tax).  The company's previously-issued financial guidance for 2012 remains unchanged.

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Health Canada issues Product Licence for Asantae RealW8


VANCOUVER AND MESA, AZ,  - Asantae Holdings International Inc. (TSXV: JVA, OTC PINK: ASNHF) ("Asantae" or the "Company"), a producer and marketer of innovative nutritional products through a network of independent distributors, today announced its subsidiary, Asantae Distribution Canada, has received a Health Canada License for its weight loss supplement, RealW8.

Hon. John Reynolds, Asantae's Chairman, stated, "With the outstanding sales performance of RealW8 in the US, we are extremely pleased that Health Canada has issued the Company this National Health Products License.  We take the safety, quality, and efficacy of our products very seriously and are proud of our team for their diligent work."

Dr. Lundell, RealW8 formulator, commented, "RealW8 is effective because it addresses the real cause of weight gain and the many associated heath consequences. We are excited to be sharing the success of RealW8 with the Canadian market."

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Eaton Scientific Announces Clinical Trial Plans for Tropine 3 - Company to Seek FDA Approval as Novel Prescription Drug for Non-Hormonal Treatment of Hot Flashes in Menopausal Women


BEVERLY HILLS, Calif., -- Eaton Scientific Systems, Ltd. ("Eaton Scientific" or the "Company"), a wholly owned subsidiary of Pristine Solutions, Inc. (OTCQB: PRTN) is pleased to announce select details of its planned multi-phase multi-location clinic trials for FDA approval of its novel drug indication Tropine 3, containing currently FDA approved Homatropine, in oral an suspension.

"We are currently finalizing preparations for what we believe will be the landmark clinical studies of our novel drug indication Tropine 3 for treatment and relief of the symptoms of hot flashes in menopausal women – one of the top concerns of women's healthcare today," stated Michael Borkowski, CEO and President of Eaton Scientific.  

 "The Company continues to build an outstanding team of very highly accredited medical professionals to plan, manage, and conduct every step of the clinic trials which were specifically designed to test, prove, and ultimately promote the short-term efficacy and safety Tropine 3.  We anticipate that final Phase 1-2 protocol preparations and patient enrollment start dates will be confirmed shortly."

Eaton intends to conduct multiple clinical trials in Phase 1-2 & Phase 3 of Tropine 3.  The first trial is planned to be an FDA protocol approved "Phase 1-2, Prospective, Randomized, Double Blind, Placebo-Controlled, Dose Escalation, Parallel-Group Study to Test the Efficacy and Safety of Homatropine Methylbromide Oral Suspension on Selected Climacteric Symptoms and Quality of Life in Menopausal Women Not Receiving Hormonal Replacement Therapy ("HRT")".  

The drug, homatropine, is an anticholinergic medication that is an antagonist at muscarinic acetylcholine receptors and thus the parasympathetic nervous system.  It is used in eye drops as a cycloplegic, and as a mydriatic in order to dilate the pupil.  Homatropine is also given as an atropine substitute given to reverse the muscarinic and CNS effects associated with indirect cholinomimetic administration.  Homatropine has been prescribed continuously and safely in the United States for over 40 years.

The Company anticipates conducting the clinic trials at multiple sites across the United States and plans to publish the results in medical journals and women's health publications.  The Company intends to begin marketing Tropine 3 to pharmaceutical companies for potential acquisition following completion of the first Phase 1-2 clinic trial.

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OncoGenex Pharmaceuticals to Present at Two Upcoming Investor Conferences


BOTHELL, WA and VANCOUVER- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that Scott Cormack, President and Chief Executive Officer, will provide a corporate presentation at the following investor conferences:

  • Stifel Nicolaus Annual Healthcare Conference on Wednesday, September 5, 2012 at 10:55 a.m. ET at the Four Seasons Hotel in Boston

  • Rodman & Renshaw Annual Global Investment Conference on Tuesday, September 11, 2012 at 2:25 p.m. ET at the Waldorf Astoria Hotel in New York City


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FAME 2 Published in the New England Journal of Medicine, Volcano participates in the $84M NIH-Sponsored ISCHEMIA Trial


MUNICH and SAN DIEGO, - Volcano Corporation (NASDAQ: VOLC) a worldwide leader in precision guided therapy tools, today celebrated the publication of the results of the FAME 2 trial in the New England Journal of Medicine (NEJM). Volcano also announced participation in the next major international functionally-guided study—ISCHEMIA that will include the newest PrimeWire® PRESTIGE PLUS Pressure Guidewires.

Ever since the COURAGE trial demonstrated that not every patient entering the cath lab benefits from stenting, the interventional cardiology community has been exploring more precise ways to identify which patients will benefit most from PCI, and which patients should instead be treated with optimal medical therapy (OMT) alone. 

The initial FAME study published in the NEJM showed that PCI outcomes can be improved by guiding a stent strategy using Fractional Flow Reserve (FFR) instead of angiography alone as was practiced in COURAGE. The results of the FAME study showed that the number of vessels that actually needed treatment was dramatically less than previously thought, and therefore reduced the complexity of the initial angiographic diagnosis.

FAME 2 (Fractional Flow Reserve-Guided PCI vs. Medical Therapy in Stable Coronary Disease) is the second FFR-guided randomized clinical trial to be published in the NEJM. It demonstrates that using stents to treat patients with proven ischemia by FFR does in fact deliver better outcomes than OMT alone in the combined endpoint of death, myocardial infarction (MI) and urgent revascularization. It is important to note that the FAME 2 trial was halted early by the Independent Data Safety Monitoring Board because it determined it was unethical to continue enrolling patients in the medical therapy only arm due to the increased risk of these significant adverse events.

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Altheus Therapeutics Announces First Patient in Phase 2 Ulcerative Colitis Trial of Zoenasa


OKLAHOMA CITY, -- Altheus Therapeutics announced today it has randomized its first patient in a comparator-controlled Phase 2 efficacy study of Zoenasa®, a novel combination therapy for ulcerative colitis (UC).

Zoenasa is a fixed-dose combination of mesalamine (current standard of care in UC) plus a second potent anti-inflammatory agent not previously used in this indication. In multiple animal models and one human study the combination has shown to be 50 to 100 percent more effective than standard therapy. The synergistic effect of the Zoenasa combination was discovered by Altheus' scientific founder, Dr. Richard Harty, past Chief of Gastroenterology at the University of Oklahoma Health Sciences Center. 

"We believe that Zoenasa will define a new category within the mesalamine-based market that could improve front-line treatment for ulcerative colitis and alter the market significantly," said Dennis Schafer, Altheus CEO.

Nearly 1.2 million Americans suffer from inflammatory bowel disease, with 2.3 million people affected worldwide. The two most common forms, ulcerative colitis and Crohn's disease, are chronic lifelong conditions which significantly impact quality of life. Front-line treatment for ulcerative colitis is mesalamine.  However, many patients do not achieve remission and must escalate to more expensive and risky treatments.

ZA201 is a double-blind, active-controlled Phase 2 study of the safety and efficacy of Zoenasa Rectal Gel and will be conducted at 25 centers in approximately 120 adult patients with left-sided (distal) ulcerative colitis.  The study's Principal Investigator is Dr. Philip B. Miner, Jr., of the Oklahoma Foundation for Digestive Research in Oklahoma City, one of the foremost clinical research investigators for IBD. ZA201's first patient was enrolled at Digestive Health Specialists of the Southeast in Dothan, AL, under Dr. Jeffery Crittenden.

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Bolder BioTechnology Announces Publication of Data Demonstrating Utility of the Company's Long-Acting IL-11 Analog to Prevent Renal Ischemia Reperfusion Injury


BOULDER, Colo., Bolder BioTechnology, Inc. announced today publication of preclinical research demonstrating utility of interleukin-11 (IL-11) and the company's long-acting IL-11 analog to prevent kidney damage from ischemia reperfusion injury in mice.  This work may lead to new therapeutic approaches to prevent acute kidney injury and ischemia reperfusion injury to multiple organ types. 

The studies were performed in the laboratory of H. Thomas Lee, M.D., Ph.D., Professor and Director of Transplantation Anesthesiology, Department of Anesthesiology, Columbia University, New York, and published as an Advance Online Publication in the American Journal of Physiology – Renal Physiology (http://ajprenal.physiology.org; published ahead of printAugust 1, 2012, doi:10.1152/ajprenal.00220.2012).

George (Joe) Cox, Ph.D., Company President stated "IL-11 is a multifunctional protein that is used clinically to treat thrombocytopenia (low platelet counts) in cancer patients receiving chemotherapy. Dr. Lee's experiments show for the first time that IL-11 also can prevent kidney damage that results when blood flow to the kidneys is temporarily blocked and then restarted (ischemia-reperfusion), such as occurs during many types of major surgeries.

 Restoring blood flow to the ischemic kidney initiates an inflammatory response that damages the healthy kidney and can lead to acute kidney injury and renal failure.  Renal ischemia-reperfusion injury is a major clinical problem that is associated with a high incidence of permanent kidney damage and high mortality in certain patient populations. There are no effective therapies for reducing the incidence of surgery-associated acute kidney injury. 

 Dr. Lee's studies showed that administration of IL-11 or our biosuperior, long-acting IL-11 analog prior to, or shortly after renal ischemia-reperfusion preserved kidney function and significantly reduced the amount of kidney cell necrosis, cell death and inflammation compared to a placebo. Dr. Lee's studies also elucidated the intracellular signaling pathways triggered by IL-11 that are responsible for protecting the kidney from ischemia-reperfusion injury.

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Clinical Site Services, Industry Leader in Patient Enrollment Solutions, Announces New Website


GLEN BURNIE, Md.,today announced that  Clinical Site Services (CSS), a leader in patient enrollment solutions for the clinical research industry, is proud to announce the launch of its redesigned website, www.ClinicalSiteServices.com.

"The first thing that visitors will notice is our individuality," shared CSS President Chris Trizna. "Yes, we are part of the patient recruitment industry, but where we differ is our focus:  our unique ability to make an impact on enrollment at each site."

This new website will provide enhanced details for sponsor companies, CROs and investigative sites who are seeking targeted data on CSS's offerings and experience, including case studies, a creative portfolio and a summary of services. Clients will be able to view real-time Facebook, Twitter, LinkedIn and YouTube feeds on the home page.

"Take a look at the case studies," added Trizna. "Clients can see where CSS's involvement positively impacts enrollment, not just responses, referrals or recruitment."

Future online offerings will include a blog centered around current patient recruitment trends and difficulties. CSS will also feature "Town Hall" style opportunities for discussion and review of specific patient recruitment challenges.

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Resverlogix's BET Protein Inhibitor RVX-208 Meets Primary Endpoint in SUSTAIN Clinical Trial in Patients With High Risk Cardiovascular Disease


MUNICH and CALGARY- Resverlogix Corp. (TSX: RVX) today announced that the BET protein inhibitor RVX-208 significantly increased HDL-C (p=0.001), the primary endpoint of the SUSTAIN trial, a phase 2b clinical study. SUSTAIN also successfully met secondary endpoints, showed increases in levels of Apo-AI (p=0.002) and large HDL particles (p=0.02), both believed to be important factors in enhancing reverse cholesterol transport activity. The SUSTAIN trial also showed that increases in alanine aminotransferase (ALT) reported in previous trials were infrequent and transient with no new increases observed beyond week 12 of the 24-week trial.

The SUSTAIN trial was directed by a clinical steering committee chaired by Dr. Steven Nissen with Dr. Stephen Nicholls serving as Principal Investigator. The committee has approved release of topline findings pending submission of full trial results for publication in a peer-reviewed medical journal.

"Successful completion of the SUSTAIN trial provides Resverlogix with important data regarding improvement in the functionality of the HDL produced by RVX-208," stated Donald McCaffrey, president and chief executive officer of Resverlogix. "Safety data from SUSTAIN reconfirm our belief that early liver signals witnessed in this and previous trials were of a transient nature," Mr. McCaffrey added. "The data support that RVX-208 is suitable for chronic use. The value of this knowledge will benefit our entire epigenetic and bromodomain research program by showing safe versions of epigenetic regulating molecules are indeed achievable. We believe that based on the collective knowledge gained from our recent trials, our company is well positioned as we approach the key plaque regression data expected in our ongoing ASSURE trial."

The phase 2b SUSTAIN trial was conducted in South Africa and led by investigators at the Cleveland Clinic. The study enrolled 176 patients with established atherosclerotic cardiovascular disease (CVD) and low high-density cholesterol (HDL-C). The primary purpose of the SUSTAIN trial was to measure changes in HDL, Apo-AI and other lipid parameters compared with placebo, while also assessing safety over an extended treatment period in the patient population with the largest response to RVX-208 in the phase 2 ASSERT trial. The increase in HDL and Apo-AI observed in the 24-week SUSTAIN trial represents a notable increase over the respective HDL and Apo-AI values reported in the 12-week ASSERT trial.

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Esperance Pharmaceuticals Announces Completion of Run-in Enrollment of Phase 2 Study of EP-100 Plus Paclitaxel in Advanced Ovarian Cancer


BATON ROUGE, La., Esperance Pharmaceuticals today announced the completion of the run-in cohort of its Phase 2, randomized, multi‐center trial of EP‑100 in combination with paclitaxel for patients with advanced ovarian cancer. EP‐100 is a targeted membrane‐disrupting peptide (tMDP) designed to seek and destroy cancer cells that over‐express luteinizing hormone releasing hormone (LHRH) receptors on their surfaces. LHRH receptors are over‐expressed in a wide range of cancers including ovarian cancer. In June, the Company presented results from the successful completion of a Phase 1 study of EP‑100 in advanced solid tumors at the American Society of Clinical Oncology (ASCO) Annual Meeting.

"We are pleased with the continued momentum behind EP‑100 and the progress of enrollment as we begin the randomized treatment phase," said Dr. Hector Alila, CEO of Esperance. "We are encouraged with early results, and look forward to accelerating enrollment in a very important, underserved patient population and providing an update on the clinical progress over time."

The randomized, Phase 2 trial of EP‑100 in combination with paclitaxel versus paclitaxel alone in patients with histologically confirmed epithelial ovarian carcinomas expressing LHRH‐receptors is actively enrolling patients in key clinical sites across the United States. Rationale for the study is based on the positive clinical evidence from escalating doses in 38 patients in the Phase 1 study and on preclinical studies showing synergies between EP‑100 and various chemotherapeutic agents.

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Aeterna Zentaris Announces First Patient Recruited for Phase 2A Trial in Cancer Cachexia with AEZS-130


QUÉBEC CITY,  Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that a first patient has been recruited for a Phase 2A trial with its ghrelin agonist, AEZS-130 in patients with cancer cachexia. The study is conducted under a Cooperative Research and Development Agreement (CRADA) between Aeterna Zentaris and the Michael E. DeBakey Veterans Affairs Medical Center which is funding the study. Cachexia, characterized by diminished appetite and food intake in cancer patients, is defined as an involuntary weight loss of at least 5% of the pre-illness body weight over the previous 6 months.

 Jose M. Garcia, MD, PhD, Assistant Professor, Division of Diabetes Endocrinology and Metabolism, Departments of Medicine, Molecular and Cell Biology, the NCI-designated Dan L. Duncan Cancer Center and the Huffington Center on Aging at Baylor College of Medicine and Michael E. DeBakey Veterans Affairs Medical Center, is acting as the Principal Investigator of this trial conducted in Houston, Texas.

Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, "This is a key study as it allows us to venture into the field of cancer-cachexia, an indication with high unmet medical needs. Because cachexia is very common among cancer patients, our oral ghrelin agonist, AEZS-130, could represent a novel treatment option for many of the 1.5 million people diagnosed with cancer each year, in the U.S. alone."

The Study

This is a double-blind, randomized, placebo-controlled Phase 2A trial to test the effects of different doses of AEZS-130 in 18 to 26 patients with cancer-cachexia. AEZS-130 will be provided by Aeterna Zentaris. The study will involve 3 sequential groups receiving differing doses of AEZS-130. Each dose group will have 6 patients who will receive AEZS-130 and 2-4 patients who will receive placebo. After analysis of safety and efficacy at each dose level vs. placebo, a decision will be taken either to decrease or increase the dose. For this study, adequate efficacy will be defined as a ≥0.8 kg of body weight gain or a ≥50 ng/mL increase in plasma IGF-1 levels. 

The primary objective of the study is to evaluate the safety and efficacy of repeated oral administration of AEZS-130 at different doses daily for 1 week in view of developing a treatment for cachexia. The following parameters will be recorded to assess efficacy during the study: change of body weight, change of IGF-1 plasma levels, and change of quality of life score (Anderson Symptom Assessment Scale, FACIT-F). Other secondary objectives will include food intake, and changes in the following: appetite, muscle strength, energy expenditure, reward from food and functional brain connectivity.

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Society for Cardiovascular Angiography and Interventions (SCAI) Statement on FAME 2 (FRACTIONAL FLOW RESERVE VERSUS ANGIOGRAPHY FOR MULTI-VESSEL EVALUATION 2)


WASHINGTON,today announced that  the FAME 2 trial will improve treatment strategies for patients with stable ischemic heart disease. FAME 2 indicates that angioplasty and stenting (also known as percutaneous coronary intervention, or PCI) plus the best available medications results in better outcomes than medications alone for patients who have significant blockages in their heart arteries, as measured by a test known as Fractional Flow Reserve (FFR). With these results, heart doctors gain new evidence to guide decisions about use of PCI.

FAME 2 is an important clinical trial in part because it enrolled consecutive patients with stable coronary artery disease, a patient group whose treatment strategy has been the subject of active debate since the 2007 presentation of COURAGE, which ultimately randomized less than 10 percent of eligible patients. In FAME 2, FFR was performed on every patient to confirm that "hemodynamically significant" (or "tight") blockages in their coronary arteries were limiting blood flow.  The patients with hemodynamically significant blockages were then randomized to PCI plus the best medications available or medications alone. 

The results of FAME 2 have been anticipated since earlier this year, when it was announced that an independent safety monitoring board halted the trial early, essentially deeming it unsafe to deny PCI to any study patients whose coronary blockages were found to be significant according to FFR. 

Today, the FAME 2 investigators provided further details on the study results:

  • Patients who received PCI plus medications were significantly less likely to require an unplanned hospitalization leading to urgent revascularization to stop a heart attack or control symptoms that became unstable; this finding favoring PCI over medications alone emerged within 6 months of randomization.

  • The patients treated with PCI plus medications experienced greater symptom relief than those on medications alone.

  • The patients who underwent PCI less frequently required treatment with anti-anginal medications compared to those receiving medications alone.

The findings from FAME 2 are now the best data currently available to inform treatment decisions for patients with stable coronary artery disease. These data clearly demonstrate that the benefit of PCI plus medical therapy in stable patients with ischemia-producing lesions extends beyond symptom relief and quality of life. 

Unlike COURAGE, the study additionally reflects the current use of evidence-based tests (such as FFR) and modern treatment options (including the use of second-generation drug-eluting stents) and their combined roles in improving patient outcomes. The results of the recently launched and ongoing NIH-funded ISCHEMIA study will provide further clarity when its results are available in approximately 2018.

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