Resverlogix Complies with Anti-Spam Laws

As you may have been receiving several emails from various companies, Canadian e-communication laws are changing.

Starting from July 1, 2014, we will need your permission to continue sending Resverlogix’s news, research and other correspondence via email.

What will happen?

An e-mail will be sent to you with a link that will confirm your continued interest in receiving Resverlogix emails.

What must you do?

These e-mails must be opened and confirmed, otherwise you will be automatically removed from the mailing list and no longer receive Resverlogix news email alerts.

As always, you may unsubscribe at any time in the future. The unsubscribe link is visible at the end of each electronically sent press release.

If you wish to read more on Canada’s Anti-Spam Legislation (CASL), please click here.

Thank you for your continued interest in Resverlogix.

Clinical Trials Series: The Final Steps

This is the final blog post in the clinical trial series. As discussed in the previous posts, multiple types of clinical trials exist and they generally happen in sequence, from Phase 1 though Phase 3, evaluating drug candidates’ safety and efficacy in humans which ultimately leads to accurate product positioning of the drug by Phase 3. Depending on the compound, indication(s) and trial design, completing the clinical trial process is extensive, costly and time consuming.

At the completion of each clinical trial, the principal investigators and sponsors of the clinical trial, such as biotech companies, analyze the data to determine whether the trial met the goal(s) set out for the compound. Depending on whether the compound has met the expectations of the specific primary endpoint or not, provides guidance whether the trial has succeeded based on a certain ideas of what the drug was hypothesized to do. In most trials, the investigators who design it postulate concepts prior to trial initiation a set of pre-specified endpoint(s) that they predict the compound should be able to achieve. Thus in most trials this is the so called ‘primary endpoint’ by which the trial is initially judged.

For example, if a compound is designed to lower glucose by X mg%, then results from a trial of patients given the compound should on average have glucose below X mg%. If so, then the trial is judged as being positive.  Additionally, in most trials the investigators set out multiple secondary and possibly exploratory endpoints which are used to gather further analysis and understanding of the potential of the drug. These endpoints are also important hurdles to judge activity of the compound. Based on the results of the trial, the clinical investigators decide on the next steps in the clinical development of the compound. Both primary and secondary endpoints help determine the accuracy of the investigators’ hypothesis.

Analyzing the top-line data is the first process after the completion of a trial. It determines the success of a trial. The analysis of the data to determine primary endpoint is the first priority. Ongoing analysis of data from the trial, especially that for the secondary endpoints takes time. Beyond the primary and secondary endpoints, there is very valuable information collected in the data from the trial. This is often analyzed as time permits. Continued analysis will help identify characteristics and activity of the compound not previously suspected or postulated by the investigators.

Given positive outcomes in each phase of the clinical trials process, development of the compound will continue. The goal is to work towards a Phase 3 trial that is successful and demonstrate significant improvement in treatment from existing medications. A successful Phase 3 trial will allow a company who owns the compound to file for a new drug application (NDA) with the U.S. Food & Drug Administration (FDA). If approved, they will bring the drug to market for the benefit of the entire patient population.  As the drug enters the market place, constant monitoring will take place as the drug is prescribed to patients. This is an ongoing process to collect data on the long term effects of the drug.

We hope you enjoyed reading the clinical trial series. The next post will discuss Diabetes Mellitus and Resverlogix’s interest in this wide spread disease.

Resverlogix Corp. Centralizes Head Office and Laboratory

We are pleased to announce the relocation and centralization of our main office and laboratory.

Effective May 1, 2014, our Midpark Way office and 31st Street laboratory in Calgary have relocated to:

300, 4820 Richard Road SW
Calgary, AB T3E 6L1
Tel: 403.254.9252 Fax: 403.256.8495
(Telephone and fax numbers remain unchanged)

If you have any questions, do not hesitate to contact us at info@resverlogix.com.

Best regards,
Resverlogix Senior Management

Resverlogix Launches IR App

Resverlogix has collaborated with CNW in creating an Investor Relations App for Apple and Android users!

As investors become more dependent on mobile devices for their consumption of information, they require the company’s investor relations content to be easily viewable and navigable.

This app gives Resverlogix Corp. (TSX: RVX) investors mobile access to the latest stock data, news, SEC Filings from Resverlogix Corp. It also provides proprietary company content including presentations, conference calls, videos, fact sheets, annual reports and other qualitative company information. Investors are able to receive ‘push’ notifications when new content is added to the IR App such as add events to calendars, share content and as well as download files for offline viewing.

We proudly introduce our new IR App to current and potential investors. You may check your phone’s App store and type “Resverlogix” or “Resverlogix IR App” in the search bar. It should be the first on the list!

You can also access download the Apps for your desktop and/or web browser at:

Apple Products (iPhone, iPod, and iPad) – https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewSofware?id=730718904&mt=8

Android Products (Tablets and Smartphones) – https://play.google.com/store/apps/details?id=com.theirapp.resverlogix

If you have any issues, please send us an email at ir@resverlogix.com

Understanding Our New Findings From ASSURE – hsCRP Biomarker

Yesterday Resverlogix announced new findings from continued analysis of data collected in the ASSURE trial of RVX-208 (see http://www.resverlogix.com/media/press-release.html?id=494).  One of the new findings relate to the fact that levels of a biomarker which reflect inflammation, so called high sensitivity C reactive protein (hsCRP), appears to be very useful in identifying ASSURE patients who benefited from the actions of RVX-208 to regress atherosclerotic plaque.

What does this mean in the development of RVX-208? To answer this question, important background information details the role of inflammation in the cause of atherosclerotic disease.  Inflammation of the vasculature is an integral component of atherosclerotic disease such as heart attacks, strokes and peripheral artery disease (PAD). One way to understand what is inflammation and how it becomes a part of a heart attack or other atherosclerotic vascular diseases is similar to the events surrounding an infection such as a boil on the skin. This problem begins with a skin infection and then the body reacts to it by recruiting the immune system to fight the infection. First, the infection is surrounded by the body’s immune cells so that the boil has a defined margin. Then the boil turns red, swells and becomes painful, reflecting the inflammatory response mounted by the body’s immune system to fix the problem. In a heart attack, the body is fighting off an enemy which in this case is cholesterol that collects in the arterial wall of blood vessels found in the heart. The immune system is called upon to get rid of the cholesterol particles using a pathway similar to that for fighting the skin infection. Imagine how the inflammatory response, comprised of redness and swellings were to take place in the confined space of a blood vessel within the heart. This inflammatory response may impede or completely block the flow of blood in the artery, leading to a heart attack or stroke.

To understand the idea of the inflammatory state within a given patient with vascular disease, hsCRP is a biomarker that is measured by simply sampling the blood. Patients in ASSURE were measured using this biomarker and find that those with a level > 2 mg/dL appeared to benefit markedly from the actions of RVX-208. In these patients, the actions of RVX-208 lead to a marked and significant regression in the plaque within the artery wall of blood vessels found in the heart. The amount of regression of the plaque is detailed in our recent press release. These beneficial actions of RVX-208 may arise from its direct or indirect (via increased apoA-I production and creation of functional HDL particles) effects to calm the inflammatory response.

How does this new observation help us in the continued development of RVX-208 to reduce risk in patients with CVD?  As the analysis of data from ASSURE continues, each finding should be viewed in the context of other useful observations collected in the trial.  The current finding, when added to previously announced observations, is that ASSURE patients with HDL-C below 39 mg/dL receiving rosuvastatin (5-20 mg/day) and then given RVX-208 for only 26 weeks were associated with a marked, rapid and pronounced regression of atherosclerosis coupled with reduced major adverse cardiovascular events (MACE). A recent scientific publication (http://www.ncbi.nlm.nih.gov/pubmed/24043299) supports the idea that increased levels of hsCRP is an additional key feature of high risk CVD populations in which MACE may be reduced by further treatment. Thus the patient profile that will benefit from treatment with RVX-208, as defined previously, can now be expanded to include an hsCRP of > 2.0 mg/dL.

This information will be very valuable in designing the next clinical trial of RVX-208 in high risk vascular disease patients.

Zenith Epigenetics Launches New Website

We are excited to inform you of the new Zenith Epigenetics website www.zenithepigenetics.com. You may access Zenith’s updated information on events, webcasts, news releases and financial information. This is a responsive site so it can be easily accessed on mobile devices.

Zenith Epigenetics Corp. is a science driven organization with a unique drug discovery platform in the area of epigenetics. Focusing on the inhibition of BET bromodomains, Zenith has successfully identified novel compounds for diseases in the areas of oncology and autoimmune disease. Zenith’s strong organization allows it to efficiently and rapidly to explore and progress these molecules from discovery to pre-clinical development, and through partnerships building a pipeline of products for both niche opportunities as well as more common diseases.

Questions or comments on Zenith can now be sent to info@zenithepigenetics.com

Thank you for visiting Zenith’s new site.

Eligibility for Investment of Zenith Shares

The company has received several inquiries about whether shares of Zenith Epigenetics Corp. (“Zenith”) are qualified investments for registered investment plans even though they are not listed for trading on a stock exchange.

On June 3, 2013, Resverlogix Corp. successfully spun out RVX Therapeutics Inc. into a newly incorporated company, Zenith Epigenetics Corp. (“Zenith”). This was completed by a Plan of Arrangement pursuant to the Business Corporations Act (Alberta). Shareholders of Resverlogix therefore received one share in Zenith for every share held in Resverlogix prior to the agreement at the effective date.

Shares of Zenith should be “qualified investments” for the purposes of the various registered investment plans provided for in the Income Tax Act provided Zenith is a “public corporation” as defined in the Act.

In particular, regulation 4900(1) (b) of the Income Tax Regulations provides that for the purposes of the various definitions of “qualified investment” in the sections relating to RRSPs (Registered retirement savings plans), DPSPs (Deferred profit sharing plans), RRIFs (Registered retirement income plans), RESPs (Registered education savings plan), RDSPs (Registered disability savings plans), and TFSAs (Tax-free savings accounts), a share of a public corporation (other than a mortgage investment corporation) is a qualified investment.

Notwithstanding that the shares of a corporation may not be listed on a designated stock exchange in Canada, the corporation may still be a public corporation if it so elects. Paragraph (b) of the definition of “public corporation” in subsection 89(1) provides that a corporation that complies with prescribed conditions relating to share ownership and trading, and that makes the required election, is a public corporation as of the time the election is made. Furthermore, the postamble to that definition provides that where a corporation has, during its first taxation year, become a public corporation (such as by making the election described above), it may elect in its income tax return to be deemed to have been a public corporation from the beginning of the year.

Zenith shares meet the prescribed conditions and have made the first election and will make the second election in prescribed manner and on a timely basis, consequently it is a public corporation, and the shares thereof qualified investments from the time they were issued under the plan of arrangement.

Clinical Trials Series: The next steps

Most clinical trials are conducted to test a medical compound, a device or a diagnostic test in human volunteers and/or patients to add evidence and medical knowledge regarding the treatment of diseases.  This information involves both efficacy and safety of a new treatment.

Before a clinical trial can start, a detailed protocol must be developed. A clinical trial protocol determines why and how a clinical study is conducted. This protocol is usually designed by experts and investigators from the company (sponsor) and/ or organizations interested in conducting the clinical trial. The clinical trial needs to be approved by internal review boards at trial sites and by the federal health authorities such as the FDA or Health Canada.  The protocol will include the reason behind the study, what will be tested, procedures of testing, participants’ eligibility criteria, number of participants, and length of study. Inclusion criteria are the factors that determine subjects’ eligibility for the trials. Exclusion criteria determine which subjects are disqualified from participating. Inclusion and exclusion criteria may include age, gender, type of disease, disease stage, current medical treatment and medical history.

As sites become active and approvals are received, patients begin enrolling. The speed at which patients are enrolled in any clinical study depends on a myriad of factors. The most important factor in enrollment is, of course, inclusion and exclusion criteria. If the disease being studied is rare or if there is strict inclusion and many exclusion criteria, then enrollment can be slower, as compared to a trial for a common disease with few exclusion criteria.

Clinical trials may be funded by healthcare companies, including biotechnology and/or pharmaceutical companies, academic and medical centers, government agencies and other organizations. All entities interested in conducting clinical trials would determine the budget necessary for each trial and raise the necessary capital for the study.

Clinical studies may be conducted at multiple sites including hospitals, universities, and community clinics. It is not uncommon for large clinical outcomes trials to enlist several hundred trial sites in multiple countries. The location is usually determined by who is conducting the study and the availability of the patient population.  Clinical studies are led by a principal investigator (PI), who is often a medical doctor, and she/he is supported by a group of doctors, nurses, social workers, and other healthcare professionals. The duration of the clinical study varies from trial to trial, depending on the phase of the trial and what is being investigated.

The next blog will discuss the final steps in the clinical trials series.

Timeline and Procedures Regarding Release of Data from Resverlogix’s ASSURE Trial

At this time no individual, institution or organization has any knowledge of the final data set for the ASSURE clinical trial. Once final data has been tabulated in late June, the data will then be shared for the first time with Resverlogix, Dr. Steve Nissen, Dr. Steven Nicholls and other Clinical Steering Committee members.

The Resverlogix management team will then share the data with Resverlogix’s Board of Directors in order to properly execute Resverlogix’s strategic planning going forward. The data for the primary endpoint, meaning the plaque regression calculations, will be promptly announced via news release and accompanied by a conference call. The data in this trial should determine if we have achieved plaque regression. Other available data, such as secondary endpoints and safety aspects will also be commented on in the news release.

Some secondary endpoint data, such as Apo AI levels, may not be ready at the time of the news release announcing the primary endpoint data. This data may be presented at a later time along with the full topline tables and data at a global cardiovascular event such as the European Society of Cardiology (ESC) Congress 2013 in Amsterdam in August/September.

In order to participate in prestigious congresses such as the ESC, AHA and ACC, the data being presented must be of original release. Our goal is to satisfy embargo regulations while providing Resverlogix stakeholders with key results in a timely fashion. Any negative data would not be deferred and would be released as soon as they have been analysed and available.

The ASSURE trial data is pivotal not only to Resverlogix but also for patients, so we will continue to develop our timelines and procedures to determine the most efficient way to advance RVX-208 to the market.

Clinical Trials Blog Series: Commencement of a trial

The practice of modern medicine is based on studies that provide evidence to support whether an approach for treating a disease is beneficial or not. Measuring the effectiveness of a particular treatment is done by conducting clinical trials. In this series of blogs, we will discuss how clinical trials help us determine whether a treatment for a particular disease is safe and effective.

Any scientific experiment, including human clinical trials, begins with a hypothesis. The trial is then conducted to test the hypothesis. For instance, it is a hypothesis that drug X is safe and effective for treating disease Y.

Clinical trials are normally divided into 4 different phases. Phase 1 is usually tested “First-In-Man” and involves single dose administration to healthy subjects. Many doses are tested to find the maximum tolerated dose. When a few doses have been selected, testing will occur in patients. This is called Phase 2 and involves normally 3 or 4 different doses given over a period of 2-3 months. It is not unusual that additional fine-tuning of doses are tested in larger patient samples to clearly confirm one efficacious and safe dose, which is called a Phase 2b. Finally, in order to file a registration (NDA), one or two larger Phase 3 studies need to be accomplished in large patient samples where you aim to seek your indication, i.e.) to prevent events of cardiovascular disease. Those studies can involve more than 10,000 patients. When a drug is tested after registration within the same indication or in a new dose, it is called Phase 4. Usually, testing a hypothesis in clinical studies requires comparing results in patients given the drug to the results in patients who were not. This is called placebo-controlled.

The results of most clinical trials are measured by something called endpoints. The endpoints determine whether the initial hypothesis is correct or not. Once the endpoints are determined, the next step is to define a target patient population for testing the hypothesis. The patient population is usually made up of people who are suffering whatever condition the drug is intended to treat. A list of criteria are created to define this population called “inclusion criteria.” A list of criteria that would exclude a subject from the study is also created called the “exclusion criteria.” The patients that fit the inclusion criteria but not the exclusion criteria are allowed to enroll in the study.

Very often, studies are also “randomized”. Patients who meet the inclusion criteria and enroll in a clinical study will receive either the drug being tested or the placebo. This assignment to either drug or placebo is done randomly – like the flip of a coin. This is to ensure there is no bias in choosing the patients in each group. Another important way to limit any potential bias in a clinical study is to make them “blind.” Blinding means that nobody involved in the study knows whether a patient is receiving the drug or the placebo.

Our next blog will discuss trial design, protocol, site openings and commencement of dosing.