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Veralox Therapeutics Announces IND Submission for VLX-1005 to Treat Heparin-Inducted Thrombocytopenia

Veralox Therapeutics Announces IND Submission for VLX-1005 to Treat Heparin-Inducted Thrombocytopenia

Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced it submitted an Investigational New Drug  (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1 clinical trial of VLX-1005, a first-in-class small molecule inhibitor of 12-Lipoxygenase in development for the treatment of heparin-induced thrombocytopenia (HIT).

HIT is an immune complication of heparin therapy resulting in low platelet counts caused by antibodies to complexes of platelet factor 4 (PF4) and heparin. Currently, one third of hospitalized patients in the U.S., or about 12 million a year, receive heparin. HIT is the most important and most frequent drug‐induced type of thrombocytopenia.

“This IND submission is a key milestone for Veralox and a tribute to the hard work and dedication of our team to advance VLX-1005 to first in human studies,” said Jeffrey Strovel, Ph.D., Chief Executive Officer of Veralox Therapeutics, Inc.

“We are excited to continue our efforts to further develop this groundbreaking new therapy for patients suffering from HIT,” David Maloney, Ph.D., Chief Scientific Officer of Veralox Therapeutics.

About VLX-1005

VLX-1005 is a first-in-class and selective small molecule inhibitor 12-Lipoxygenase, a key target within the arachidonic acid pathway. Preclinical data has demonstrated that VLX-1005 halts immune driven platelet activation and thrombosis thus offering the potential of a lifesaving treatment for patients with HIT.

About Veralox Therapeutics

VERALOX Therapeutics Inc. ( is developing first-in-class therapeutics that target the underlying pathologies of diseases with unmet medical needs. The company’s lead candidate, VLX-1005, will be developed initially to treat patients with heparin-induced thrombocytopenia (HIT). Second generation therapeutic products are under development for T1D and other immune-mediated and inflammatory diseases.


Jeffrey Strovel, CEO

Importance of Early Planning for Cell Therapy Clinical Trials

Importance of Early Planning for Cell Therapy Clinical Trials

Early planning is critical, both for cell therapy clinical trials and commercial-scale operations. By addressing how activities will be managed early on, it can minimize risk and cost, and optimize downstream processes. However, oftentimes clients are unsure of which components are critical to address early on.

In this blog I’ll address the top question clients often ask me, “What are the key components of a cell therapy clinical trial that I should consider early on, and why?”

There are several factors but the most important include:

Study Protocol
The way the study is designed is the crux of the clinical trial.  It will directly affect the execution and logistics as you navigate through the development phases so it’s important that significant time and thought is put towards this step early on.

The more complex the study protocol design is (i.e. double blinding), the earlier it needs to be communicated.  If not communicated, it can lead to logistical challenges such as packaging, labeling, as well as misinformed study personnel, all of which can cause delays in kickoff and/or implementation.

Site Location
Early planning for the number of clinical sites and their locations has a direct impact on the execution of a cell therapy clinical trial.  Remote or inaccessible clinical site locations will affect distribution of material as well as recruitment and treatment.

A team of qualified individuals are needed to support the clinical trial; especially a Principal Investigator. A PI with significant experience in study participant recruitment, patient follow-up and strong regulatory knowledge is important in choosing a study site.

The on-site personnel also affects the site location as they need proper clinical trials skills and on-going or up-to-date regulatory training.  Without training, the cost of the trial can increase due to poor paperwork documentation, poor management of study product, and non-compliance with protocols.

Supply Chain Management
It is important to consider a coordinated supply chain management plan as early as possible within the therapies development. This will give you peace of mind that your product is delivered to the right patient at the right time, location, and temperature.

Additionally, as you scale it’s important that your vendors scale with you.  When searching for an ideal supply chain partner to support, consider the following characteristics:

By considering these key components early on in your cell therapy clinical trial planning, it will lead to proper implementation, smooth operations and attainment of study objectives.

Posted by
Moronke Iyoha
Author Bio
My background is in clinical trial coordination and management, with 8 years of experience ensuring delivery of all services and technical aspects of large multi-center projects. While I trained as a Physician, I believed in the words of Dr. Riffenburgh; "When you treat a patient, you have treated a patient. When you do research, you have treated ten thousand patients.” Growing up in a developing country with many dying from easily preventable diseases, I was determined to be part of any change that promotes and enhances health. I received my medical degree from Olabis Onabanjo University, Nigeria and my Masters degree in Public Health from Johns Hopkins University. As a Project Manager with Fisher BioServices, I get to facilitate successful implementation of projects which could ultimately impact the lives of thousands. Effective communication and organizational skills are keys to a project's success.
Big Announcements from Maryland Tech Council

Big Announcements from Maryland Tech Council

Please see important information below regarding our office move, guest blogs and member videos! Let me know if you have questions.  I’m looking forward to seeing you soon!

  • Big Move

    Maryland Tech Council is saying goodbye to our old digs on September 20, 2017.  Please make note, our communications will be down that day and we will resume full activity on September 21, 2017.  MTC’s new headquarters will be located at Launch Workplaces in Gaithersburg MD, 9841 Washingtonian Boulevard, Suite 200, Gaithersburg MD 20878.

  • Be a Guest Blogger

    Maryland Tech Council is launching the Member Point of View (POV) guest blogs.  We are inviting members to submit content for our blog page.  The content will be focused on your niche/industry where you can add a new POV for the MTC audience. Our goal is to position you as an authority and well-known name in the industry. And for us, we will have fresh new content for the page and get new readers to our blogger community.  It’s simple and a win-win.  We will have numerous categories that you can write articles for; those will be available in the next few weeks.  We are kicking off the Member POV blogs during Cyber Security Awareness month in October.  If you are interested in submitting a blog on that topic, please let me know and we will get you started.

  • Become a Familiar Face in the Community

    Maryland Tech Council is revitalizing the “member spotlight” that is featured in the VIBE E-newsletter. We now offer the opportunity to feature you, the member, through our new and exciting video blog or vlog.  The video will be 30-45 seconds, prerecorded at our offices, about your company. We will then feature the vlog in our monthly VIBE E-newsletter.  The vlogs allow us to distribute the member spotlight through other formats such as twitter, Facebook, etc. to get you more exposure.  I mean, we are the Tech Council, right?  


Remember, everyone in your company is a member of MTC. Please share this important information with your team.

Warm Wishes,

Michelle Ferrone
EVP, Operations
Maryland Tech Council