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CARLSBAD, Calif., Dec. 20, 2011 /PRNewswire/ — Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 1 study of ISIS-FGFR4Rx, an antisense drug designed to treat obesity.  ISIS-FGFR4Rx specifically reduces the production of fibroblast growth factor receptor 4 (FGFR4) in the liver and fat tissues, which decreases the body’s ability to store fat while simultaneously increasing fat burning and energy expenditure.   Because ISIS-FGFR4Rx does not distribute to the brain or central nervous system (CNS), ISIS-FGFR4Rx should not produce any CNS side effects.  Many anti-obesity drugs primarily work to suppress appetite by acting in the brain, commonly resulting in CNS side effects. 

“Obesity is an epidemic in the United States and much of the rest of the industrialized world.  Obesity is a serious condition that increases the risk of diabetes, heart disease, stroke, arthritis and some cancers.  Severely obese patients make up the most rapidly growing part of the obese population.  In these severely obese patients, bariatric, or weight-loss, surgery is a preferred therapeutic option; however long-term weight loss remains a challenge for these patients,” said Richard Geary, Ph.D., Senior Vice President of Development at Isis.  “Many of the recent therapies under development or on the market to treat obesity have unacceptable safety profiles.  Clearly there is a significant need for a treatment approach that can cause weight loss without deleterious side effects.”

“We are developing ISIS-FGFR4Rx for patients who are severely obese and for the treatment of obesity in patients who are at high risk for cardiovascular and metabolic diseases.   In preclinical studies, inhibition of FGFR4 led to robust and sustained weight reduction in obese animals, accompanied by an improvement in insulin sensitivity,” said Sanjay Bhanot, M.D., Ph.D., Vice President of Clinical Development and Translational Medicine at Isis.  “In obese animals, antisense inhibition of FGFR4 enhanced weight loss when administered as a single agent or in combination with an appetite-suppressing drug, suggesting that peripheral inhibition of FGFR4 in combination with other types of anti-obesity drugs could be a novel therapeutic approach for the treatment of obesity.  Because ISIS-FGFR4Rx selectively alters fat metabolism in metabolically active tissues such as liver and fat without distributing to the brain or heart, we do not expect ISIS-FGFR4Rx to produce cardiac or CNS side effects.” 

ISIS-FGFR4Rx is the first drug in Isis’ metabolic franchise to treat obesity and utilizes technology Isis in-licensed from Verva Pharmaceuticals.

ABOUT ISIS PHARMACEUTICALS, INC.

Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners.  Isis’ broad pipeline consists of 28 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic and severe and rare/neurodegenerative diseases, and cancer.  Isis’ partner, Genzyme, plans to commercialize Isis’ lead product, mipomersen, following regulatory approval, which is expected in 2012.  Isis’ patents provide strong and extensive protection for its drugs and technology.  Additional information about Isis is available at www.isispharm.com.

ISIS PHARMACEUTICALS’ FORWARD-LOOKING STATEMENT

This press release includes forward-looking statements regarding the discovery, development, activity, therapeutic potential and safety of ISIS-FGFR4Rx.  Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs, including the planned commercialization of mipomersen, is a forward-looking statement and should be considered an at-risk statement.  Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.  Isis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements.  Although Isis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis.  As a result, you are cautioned not to rely on these forward-looking statements.  These and other risks concerning Isis’ programs are described in additional detail in Isis’ annual report on Form 10-K for the year ended December 31, 2010 and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.

In this press release, unless the context requires otherwise, “Isis,” “Company,” “we,” “our,” and “us” refers to Isis Pharmaceuticals and its subsidiaries, including Regulus Therapeutics Inc., its jointly owned subsidiary.

Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc. 

SOURCE Isis Pharmaceuticals, Inc.

Kristina Lemonidis, Director, Investor Relations, +1-760-603-2490; or Amy Blackley, Ph.D., Assistant Director, Corporate Communications, +1-760-603-2772, both for Isis Pharmaceuticals, Inc.

Melbourne, Australia (13 May, 2011).  Verva Pharmaceuticals Ltd. is pleased to announce that the Company has completed an AUD 2 million financing (in two tranches) by current investors GBS Venture Partners Ltd. (through the Genesis IIFF Trust), Queensland Biocapital Funds Pty Ltd. and Uniseed (through the Universities Innovation Investment Trusts).  The investors were issued dividend-bearing Class A preference shares with associated redemption rights and liquidation preferences. The funds will be used to complete the ongoing phase 2a clinical trial in type-2 diabetes with the company’s lead product VVP808 as well as preclinical work on target identification and validation.

The Series A investment, along with the terms of Series A preference shares, was approved by shareholders at Verva’s Annual General Meeting, held Friday 29 April 2011.  At this meeting shareholders also:

(a)  re-elected Dr. Andrew Baker and Dr. Ian Nisbet as Directors; and
(b) elected Dr. Kathy Nielsen as a Director; and
(c) approved a further investment of up to AUD 500,000 (Class A preference shares) that  may be made available to institutional or sophisticated investors¹ within the next 6  months.

Further details of these resolutions are available on the Verva Pharmaceuticals website http://www.vervapharma.com/investors/notices-and-reports/

¹ As defined in Section 708 of the Corporations Act 2001 (Cwlth)

About Verva
Verva Pharmaceuticals Ltd. is a clinical-stage pharmaceutical company developing novel therapies to treat diabetes and to prevent and treat obesity.  Verva’s lead product VVP808 is a non-thiazolidinedione, non-PPAR-modulating insulin sensitiser currently undergoing phase 2a clinical proof-of-concept testing in type 2 diabetes.  The active ingredient of VVP808 was originally approved in North America over 50 years ago in an unrelated indication.  Its unexpected anti-diabetic activity was identified using Verva’s proprietary GES discovery platform.  VVP808 clinical data are expected in Q1, 2012.  In preclinical studies VVP808 also demonstrated additional benefits such as weight and fat loss and potential glucose-lowering synergy in combination with metformin.  In addition to VVP808, Verva’s pipeline includes: (i) a program to elucidate the molecular target responsible for the VVP808 glucose lowering effect; (ii) a drug discovery program developing next-generation insulin sensitizers based on VVP808 structure and mode-of-action; and (iii) preclinical proof-of-concept with two obesity-focused technologies that block de novo fat formation.  Further information can be found on the company’s website www.vervapharma.com.

Melbourne, Australia (31 January, 2011).  Verva Pharmaceuticals Ltd. is pleased to report that Isis Pharmaceuticals Inc. (Nasdaq: ISIS) has formally added ISIS-FGFR4_Rx (fibroblast growth factor receptor 4 antisense oligonucleotide) to its development pipeline.  In August 2009, Verva announced an agreement providing Isis an exclusive license to Verva’s intellectual property targeting FGFRs with antisense technology for the treatment of metabolic disorders, including obesity.  ISIS-FGFR4_Rx is the first drug in Isis’ metabolic franchise to treat obesity.

Further details on the ISIS-FGF4Rx program can be found in the recent Isis press release at www.isispharm.com.

Verva CEO Vince Wacher commented: “Isis has been an excellent partner and we are very pleased with the results from our collaborative work on this important target.  Isis has advanced its FGFR anti-obesity drug into development.  Inhibition of the FGFR pathway has been shown to prevent fat cell formation in human cells in vitro and in animal models and could offer promising antisense targets for obesity and other diseases.  We look forward to continued development of drugs targeting this promising pathway.”

Under the terms of the license to Isis, Verva received an undisclosed upfront payment and is eligible for future milestone payments and royalties.

About Verva Pharmaceuticals Ltd.
Verva Pharmaceuticals Ltd. is a clinical-stage pharmaceutical company developing novel therapies to treat diabetes and to prevent and treat obesity.  Verva’s lead product VVP808 is a non-thiazolidinedione, non-PPAR-modulating insulin sensitiser currently undergoing phase 2a clinical safety and efficacy testing in type 2 diabetes.  VVP808 was originally approved over 50 years ago in an unrelated indication.  Its unexpected anti-diabetic activity was identified using Verva’s proprietary GES discovery platform.  Verva preclinical studies have demonstrated that VVP808 may cause weight and fat loss and may have glucose-lowering synergy in combination with metformin.  In addition to VVP808, Verva’s pipeline includes a drug discovery program developing next-generation diabetes therapies based on VVP808 structure and a program to elucidate the novel diabetes mode-of-action.  Further information can be found on the company’s website www.vervapharma.com.

People with diabetes invited to participate in trial

Media release: Geelong, Friday 23 April 2010 (Download PDF)

Modern drugs can stabilise adult onset diabetes but with some serious side effects. A Geelong-based company, Verva Pharmaceuticals, has a new approach – a drug used for many years to treat eye disease. In animal testing, the drug restored sensitivity to insulin. But will it be effective and safe in people?  

Verva is collaborating with Deakin University, and physicians at the Geelong Hospital to conduct a clinical trial. They are looking for 80 people with adult-onset diabetes (also called type-2 diabetes) who are not currently being treated with diabetes medication. Several Melbourne hospitals are likely to join the trial in the coming months.  

The clinical trial builds on work at Deakin University’s Metabolic Research Unit (MRU) which has developed a technique for rapidly screening compounds as potential diabetes treatments. Their tests found that a compound used in the 1970s as therapy for eye disease could re-sensitise tissues to insulin.

The Phase 2a study will determine the safety and effectiveness of the compound, now known as VVP808. The chronic effects of VVP808 in diabetes have not previously been measured. The company is also investigating how the structure of VVP808 can be modified and used to build new insulin sensitisers with improved efficacy and reduced side-effects.

“Insulin sensitisers are important tools in diabetes therapy,” says Verva CEO, Vince Wacher, “but significant side effects with existing products mean there is a market demand for a new sensitiser with improved safety and a different mode-of-action.”

Verva was established in December 2007, by merging the diabetes interests of another Geelong-based company, ChemGenex Pharmaceuticals (ASX: CSX), with Brisbane obesity-focused biomedical company Adipogen Pharmaceuticals.

It was good timing. Many experts say diabetes is reaching epidemic proportions. Its incidence is increasing dramatically worldwide, in concert with the growth of obesity. The number of patients with diabetes in Australia is expected to double in the next 20 years. According to business information company Datamonitor, the multi-billion dollar worldwide market for diabetes therapy is expected to double faster than that—in only seven years.

The clinical trial of VVP808 will be a test of the company’s Gene Expression Signature (GES) drug-discovery technique. To develop the technique, MRU researchers took technology originally developed for cancer research and applied it to diabetes, says the Unit’s deputy director, Dr Ken Walder.

The GES technique depends on microarrays, a means of assessing the levels of thousands of genes simultaneously. Collective changes in the levels of certain genes—the gene expression signature—are related to the restoration of insulin sensitivity in diabetic cells. The GES can be used to assess how effective candidate compounds are at re-sensitising tissues to insulin by determining how closely they move the GES towards that of healthy cells.

“Geelong is internationally known as a particularly good area in which to undertake clinical trials,” Wacher says. “It is the right size and diversity, and serves as a therapeutic hub for a regional population from which we can recruit trial participants. Geelong Hospital has good facilities, and the investigators and clinical team with whom we work have extensive laboratory and clinical experience with large international pharmaceutical companies.”

“The trial is a randomised, double-blind, placebo-controlled trial in people who have diabetes but have not been on any other medication,” says Dr Geoff Nicholson, head of the Department of Clinical and Biomedical Sciences at the Geelong Hospital.

For further details download the Verva Backgrounder and the contact: Niall Byrne, +61 (3) 9398-1416, niall@scienceinpublic.com.au. For interview: Vince Wacher PhD, CEO Verva Pharmaceuticals, +61 (448) 871 479, vwacher@vervapharma.com.

Potential study participants or medical professional interested in learning more about the VVP808 clinical study, including potential risks and side effects, may call the study coordinator in their area (see contact list).

Geelong, Australia (11^th November, 2009).  Verva Pharmaceuticals Ltd. today announced that Professor. Michael A. Cowley, Director of the Monash Obesity & Diabetes Institute, has joined the Company’s Board as a non-executive Director.  Professor Cowley is a Victorian Endowment for Science, Knowledge and Innovation (VESKI) Innovation Fellow and a Pfizer Senior Research Fellow for 2009.  Recently Professor Cowley was awarded the prestigious Commonwealth Science Minister’s Prize for Life Scientist of the Year.

Professor Cowley has extensive experience in the discovery and development of therapies to treat metabolic diseases and the repurposing of existing medicines as therapies for obesity and diabetes. Professor Cowley was a founder and Chief Scientific Officer of California-based Orexigen® Therapeutics, Inc. (NASDAQ: OREX) and a scientist in the Division of Neuroscience at the Oregon National Primate Research Center of the Oregon Health & Science University.  During his tenure at Orexigen® the company advanced a combination product (Contrave®)* to successful phase 3 clinical testing as an obesity therapy with a second product (Empatic^TM)* completing phase 2 testing.

Professor Cowley joins Verva’s Board just as the Company brings its first product, VVP808, into clinical development.  VVP808 is a repurposed medicine which acts as an insulin sensitiser in animal models

 ”We are delighted and privileged to have a person with such extensive academic and commercial experience join the Verva Board”, stated Dr Ian Nisbet, Verva’s Chairman.  “Michael’s insights will be invaluable in effectively advancing VVP808 as a diabetes therapy.”

Professor Crowley commented, “Verva is an exciting company with a novel approach to the treatment of diabetes and I am pleased to have the opportunity to contribute to the development of the company and its products.”

* Contrave® and Empatic^TM are registered trademarks of Orexigen® Therapeutics, Inc.

About Verva Pharmaceuticals Ltd.
Verva Pharmaceuticals Ltd. is a clinical-stage pharmaceutical company developing novel therapies to treat diabetes and to prevent and treat obesity.  Verva’s lead product VVP808 is a non-thiazolidinedione insulin sensitiser entering phase 1b/2a clinical safety and efficacy testing in type 2 diabetes.  VVP808 was previously approved in North America in an unrelated indication.  Its unexpected anti-diabetic activity was identified using Verva’s proprietary GES discovery platform.  Verva’s pipeline includes: (i) an accelerated discovery program developing next-generation diabetes therapies based on VVP808 structure and mode-of-action and (ii) preclinical proof-of-concept with two obesity-focused technologies that block de novo fat formation.  Further information can be found on the company’s website www.vervapharma.com.