BASi and Seventh Wave Laboratories Combine Operations to Provide Broader Solutions and Greater Scientific Expertise to Clients

July 2, 2018

WEST LAFAYETTE, Ind., July 02, 2018 (GLOBE NEWSWIRE) — Bioanalytical Systems, Inc. (NASDAQ:BASI) and Seventh Wave Laboratories, LLC, today announced that they have signed an asset purchase agreement (APA) joining operations to provide broader solutions and greater scientific expertise to clients.

BASi provides contract research services and niche instrumentation to the life sciences industry, primarily in drug research, discovery, and development in commercial and academic settings. The company’s non-clinical toxicology laboratory provides clients with drug safety and general toxicology services, including carcinogenicity studies, DART and juvenile toxicology studies. The company offers regulated bioanalytical method development and analysis. In addition, the company provides non-clinical PK/PD from a purpose-built in vivo discovery center that includes a dedicated vivarium utilizing BASi’s proprietary Culex® Automated Sampling Systems.

Seventh Wave Laboratories provides consultative integrated services to assess safety and efficacy of pharmaceuticals and devices. Bioanalysis, pharmacokinetics, and histopathology services cover discovery through regulatory approval, and are fully GLP compliant. The company’s in vivo services focus on discovery stage support. Unique pharmacology model development and special pharmacology models are also offered, with emphasis on hepatitis B virus pharmacology using liver humanized chimeric models.

By combining offerings, the two companies expect to capitalize on their collective skill sets, expertise, and assets to create a comprehensive portfolio highlighting:

  • Lead optimization and candidate selection
  • BASi Culex® Automated Sampling Systems
  • In vivo toxicology and pharmacology
  • GLP in vivo services
  • GLP and non-GLP bioanalysis
  • Histopathology including immunohistochemistry and image analysis
  • Pharmacokinetics
  • In vitro and in vivo bioequivalence testing

Established in 2003, Seventh Wave Laboratories has a proud history and in 2017 generated annual revenues of approximately $11 million.

“For both BASi and Seventh Wave Laboratories, our success has been built on a solid foundation of quality, on-time delivery and a commitment to providing personalized and responsive service to our clients,” said Philip Downing, senior vice president of preclinical services at BASi. “We believe Seventh Wave’s scientific depth and expertise in histopathology, pharmacokinetics, investigative toxicology and pharmacology model development perfectly complement BASi’s offerings and make this combination an excellent strategic fit. By bringing our companies together, we intend to provide the same dedication and focus our clients have come to expect, while delivering expanded options and more comprehensive solutions. We are proud and very excited to begin this new venture with Seventh Wave.”

John Sagartz, DVM, PhD, DACVP, president and founder of Seventh Wave Laboratories, added, “We’re so thrilled to be able to bring together these two organizations. Over the past 15 years, we’ve engaged hundreds of clients to facilitate their discovery and development needs. With BASi, we add capabilities that have often been requested, but have not been available through Seventh Wave alone. Through extensive collaborations over the past several years, it is apparent that the two organizations share a focus on delivering quality and timely services. We expect the enhanced capabilities and shared core values to facilitate enriched client interactions and further growth.”

Transaction Summary

Pursuant to the terms of the APA, Seventh Wave Laboratories received 1,500,000 Common Shares of BASI and approximately $7 million in cash (a portion of which remains in escrow) in exchange for substantially all of its assets. In order to finance the cash component of the consideration, BASi entered into a new term loan with First Internet Bank for $5.5 million and increased the borrowing availability under its existing line of credit from $2.0 million to $3.5 million. As of the closing of the transaction, Seventh Wave Laboratories held approximately 17% of BASi’s issued and outstanding Common Shares.

A Current Report on Form 8-K containing further details regarding the APA and the transaction will be filed by BASi.

About Bioanalytical Systems, Inc.

BASi is a pharmaceutical development company providing contract research services and monitoring instruments to the world’s leading drug development companies and medical research organizations. The Company focuses on developing innovative services and products that increase efficiency and reduce the cost of taking a new drug to market. Visit www.BASinc.com for more information about BASi.

About Seventh Wave Laboratories, LLC.

Seventh Wave Laboratories is a consulting-based contract research laboratory located in Maryland Heights, Missouri that provides integrated services for discovery and preclinical drug development. By integrating PK/ADME, bioanalysis, toxicology and pathology, the company provides local, national and international clients a multidisciplinary environment that accelerates their program and goals with focused strategy and execution. For more information, visit www.7thwavelabs.com.

This release may contain forward-looking statements that are subject to risks and uncertainties including, but not limited to, risks and uncertainties related to changes in the market and demand for our products and services, the development, marketing and sales of products and services, changes in technology, industry standards and regulatory standards, and various market and operating risks detailed in the company’s filings with the Securities and Exchange Commission.

Company Contact:
Jill Blumhoff
Chief Financial Officer &
Vice President of Finance
Phone: 765.497.8381
jblumhoff@BASinc.com

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/9af55093-8993-43ce-888d-c3308d3af4e5

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Indiana MSA’s Highlighted in National Bioscience Economic Impact Report

July 2, 2018

June 5, 2018

Contact: Kristin Jones, IHIF

kjones@ihif.org or 317-752-9809

BOSTON, MA and INDIANAPOLIS, IN – The Biotechnology Innovation Organization (BIO),  TEConomy Partners LLC, and PMP Public Affairs Consulting today released the 2018 report, “Investment, Innovation and Job Creation in a Growing U.S. Bioscience Industry”.  This eighth, biennial report focuses on the economic progress and footprint of the industry geographically including the performance, positioning and latest trends in the bioscience industry for the nation, states, and metropolitan areas.

BIO’s latest report shows that the U.S. bioscience industry has reached record setting annual economic impact, venture capital investment and job growth numbers. Among U.S. technology sectors, the bioscience industry is a leading economic driver and job generator across the U.S., with job growth in 41 states.  The U.S. bioscience industry directly employed 1.74 million people in 2016 in more than 85,000 establishments.  Industry wages are consistently higher and growing faster, on average, than those for the overall economy with the average bioscience worker earning nearly $99,000 in 2016.  Combined, the industry accounts for $2 Trillion in national economic output.

The report shows that Indiana is well-positioned.  The state is considered large with specialized employment concentrations in three of the five bioscience subsectors, excelling in: Agricultural Feedstocks and Industrial Biosciences, Drugs and Pharmaceuticals, and Medical Devices and Equipment.  While still considered a strong player, Indiana did not appear as large and specialized in the category of Bioscience-Related Distribution.  The Indianapolis metropolitan area however, ranked 23rd in areas with the largest related employment levels in 2016, with 4,341 people directly employed.

The report’s focus on metropolitan areas also shows that the bioscience industry’s impact is statewide, with the communities of Indianapolis – Carmel – Anderson, Lafayette -West Lafayette, Bloomington, Terre Haute, South Bend – Mishawaka, Louisville – Jefferson Co, IN-KY, Chicago – Naperville – Elgin, IL – IN – WI, and Evansville, IN-KY being recognized for their strengths across all five of the subsectors.  In the U.S., only twenty-six metro regions have a specialized concentration in at least three bioscience subsectors,  Indiana communities claim three of those spots (Indianapolis, West Lafayette, and Bloomington).

“This report affirms that Indiana’s bioscience sector is both geographically broad and community-driven with regional centers of excellence that combine to create a strong industry presence”, said Kristin Jones, President and CEO of the Indiana Health Industry Forum (IHIF).   “Local officials may want to consider using this data to help further their economic development strategies and we stand ready to assist”.

IHIF is participating in the 2018 BIO International Convention taking place this week in Boston, Massachusetts. For more information about the report, state-specific highlights, and the Convention, please visit https://www.bio.org/insights.

About BIO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

About IHIF

The Indiana Health Industry Forum (IHIF) is the state affiliate of the Biotechnology Innovation Organization (BIO).  IHIF is a statewide trade association representing members of Indiana’s bioscience business community.  Our mission is the connect key stakeholders to: enhance business networks, advocate for member interests, develop workforce skills, and provide strategic vision in the interest of growing the state’s health industry economy and reputation.  For more information or to become a member, please visit www.ihif.org.

 

Apexian Pharmaceuticals’ Dr. Mark Kelley recognized as an outstanding researcher at Indiana University/Purdue University IUPUI

April 26, 2018

Apexian Logo Font

Indianapolis, IN – Apexian Pharmaceuticals, a clinical-stage biotechnology company focused on developing safe and effective therapy for patients with high unmet medical needs, is pleased to announce that its Chief Scientific Officer, Mark Kelley, PhD, was recognized as an outstanding scholar and researcher during the annual IUPUI Chancellor’s Academic Honors Convocation on April 20. Dr. Kelley was named the recipient of the Glenn W. Irwin Jr., M.D. Research Scholar Award for his high level of achievement in research, scholarship, or creative activity that stands as a visible representative of excellence for the entire campus.  The award recognizes the outstanding achievements of Dr. Glenn W. Irwin Jr., who was a professor, dean of IU School of Medicine, chancellor of the Indianapolis campus and vice president of IU.

The convocation, hosted by IUPUI Chancellor Nasser H. Paydar, celebrated excellence across all areas of IUPUI’s mission: teaching and learning; research, scholarship and creative activity; civic engagement; and diversity.

Steve Carchedi, Apexian’s CEO, said, “Dr. Kelley is a dedicated researcher whose work is making a significant impact in the lives of patients. This is a well-deserved recognition and we are honored that he is leading the way for Apexian.”

Dr. Kelley’s work has focused on translational research in DNA damage and repair to determine how those activities can be exploited therapeutically to treat cancers and protect normal cells from DNA damage. He has focused specifically on the enzyme called APE1 as a therapeutic target in cancers and other diseases. Dr. Kelley discovered and has been developing a specific inhibitor of APE1, called APX3330, which is now being studied in a Phase I clinical trial. The drug has potential uses in a number of cancers including ovarian, colon, bladder, pancreatic, leukemia, and other adult and pediatric cancers.

Dr. Kelley is the Betty and Earl Herr Professor of Pediatric Oncology Research and professor of pediatrics and of biochemistry and molecular biology at IU School of Medicine and associate director of basic science research at the Indiana University Melvin and Bren Simon Cancer Center.

About Apexian Pharmaceuticals
Apexian Pharmaceuticals is a clinical-stage biotechnology company focused on developing safe and effective therapy for patients with high unmet medical needs.  Apexian’s lead drug candidate is named APX3330. To learn more about Apexian Pharmaceuticals, please visit the company’s website at www.ApexianPharma.com

Media Contact: Roger D. Miller
Email: PR@Apexianpharma.com
Telephone:  844-463-3330 x113

 

BASi and Phlebotics Form Strategic Alliance; Continuing a Commitment to Automated Blood Sampling

April 4, 2018

WEST LAFAYETTE, Ind., April 4, 2018 (Newswire.com) –  Bioanalytical Systems, Inc. (NASDAQ:BASI) (“BASi” or the “Company”) today announced a technology alliance with Phlebotics, Inc. This agreement is the latest of BASi partnerships, including those with Joanneum Research and PalmSens, to expand  their offering of products and services that improve data and increase the speed of bringing new drugs to market.

This alliance focuses on technology for automated blood sampling. For nearly 20 years, the BASi Culex® Automated Blood Sampling System has been a game changer in drug research by enabling stress-free sampling from large and small animal models. Phlebotics will continue its developments toward clinical applications.

BASi and Phlebotics have previously partnered on related projects. This new alliance will support Phlebotics through research and beta testing stages of product development. “When you consider BASi can sample blood from freely moving rodents with reduced pain, stress, blood loss, and labor, it makes sense to consider the advantages for clinical trial subjects and patients,” said Pete Kissinger, a founder of both firms. “This partnering strategy will give us a head start in getting the product into the hands of clinicians.”

Philip Downing, BASi Senior Vice President of Preclinical Services, added, “BASi is excited to collaborate with a partner who is equally committed to advancing automated pharmacology practices. At the animal level, we have seen an impact on the speed and quality of data that can be achieved with automation. We’re excited to see this technology being explored for clinical applications, and we expect to advance our research for animal products, as well.”

For BASi, this alliance supports the expansion of the company’s preclinical product and service offerings. For Phlebotics, the alliance will facilitate using the knowledge gained from its initial clinical trials to refine their product for future hospital workflows. Pete Kissinger added, “We see the Phlebot as a component in the Internet of Medical Things (IoMT), or what is sometimes called the smart ICU.”

 

About Bioanalytical Systems, Inc.
BASi is a pharmaceutical development company providing Preclinical, Toxicological and Bioanalytical contract research services and monitoring instruments to the world’s leading drug development companies and medical research organizations. The Company’s in vivo automated sampling center is a purpose-built facility including ten in vivo labs, colony rooms for rats and mice with individually ventilated housing systems (IVCs), rodent surgical site, and a wet lab and cage wash facility that is complemented by state-of-the-art cold storage, formulations and bioanalytical facilities. The Company focuses on developing innovative services and products that increase efficiency and reduce the cost of taking a new drug to market. Visit http://www.BASinc.com for more information about BASi.

About Phlebotics, Inc.
Phlebotics, Inc. is a development stage company organized in 2007 expressly for the purpose of improving medical diagnostics in hospitalized patients as well as early-stage clinical trials for novel drugs and formulations using automated serial blood sampling that reduces risk, discomfort, blood waste and labor while improving data quality. Phlebotics products are for investigational use only (IUO) and are not approved by the Food and Drug Administration for the prevention, diagnosis or treatment of disease. Visit http://www.phlebot.com to learn more.

This release may contain forward-looking statements that are subject to risks and uncertainties including, but not limited to, risks and uncertainties related to changes in the market and demand for our products and services, the development, marketing and sales of products and services, changes in technology, industry standards and regulatory standards, and various market and operating risks detailed in the company’s filings with the Securities and Exchange Commission.

Company Contact:
Jill Blumhoff
Chief Financial Officer &
Vice President of Finance
Phone: 765.497.8381
jblumhoff@BASinc.com

B2S Life Sciences Plans Long-Term Growth, R&D in Central Indiana

March 7, 2018

FRANKLIN, Ind. (March 7, 2018) – B2S Life Sciences, a biotherapeutic drug development company, announced plans today to expand its operations in Johnson County, creating up to 23 new, high-wage jobs by 2020.

“Indiana has earned a reputation as a global leader in life sciences, ranking second in the nation for worldwide exports,” said Elaine Bedel, president of the Indiana Economic Development Corporation (IEDC). “At its new facility, B2S can continue to advance new technologies and life-saving research, while simultaneously investing in Indiana’s future workforce, propelling other entrepreneurs and creating good jobs for Hoosiers. We’re excited to witness B2S’ continued growth alongside our life sciences sector here in Indiana.”

The company, which develops pharmaceutical and diagnostic biological reagents, is investing $1.5 million to expand and renovate its nearly 3,000-square foot facility at 97 E. Monroe St. in Franklin, adding 9,000 square feet of laboratory space. The new building, which is scheduled to be operational in the summer of 2018, will allow B2S to grow its client base, which includes large contract research organizations (CROs), pharmaceutical companies, and smaller biotech businesses and startups. The company also plans to scale its reagent manufacturing to meet export demands and expand its services in biotherapeutic drug development.

B2S currently has 16 full-time employees and plans to begin hiring this year for scientists, project managers, statisticians, and business development and management associates. New positions are expected to offer average salaries above the state and county average wage. Interested applicants may learn more about the company’s career opportunities online or submit a resume at info@B2SLifeSciences.com.

“Recruiting and hiring local talent in the area is a priority for us,” said Dr. Ron Bowsher, chief scientific officer at B2S. “From the onset, we have worked together to enhance the local area where we live and work. This priority is reinforced by the fact that many of our lab staff reside in the southern portion of Marion County or Johnson County and by our close partnership with Franklin College. We look forward to continuing to grow the life sciences and biotech presence in central Indiana.”

Founded in 2015, the company specializes in drug development support with products and analytical services that facilitate drug research. Through its collaborative efforts, B2S scientists are contributing to advance treatments for cancer, diabetes and other chronic diseases. Along with its planned growth, the additional lab space will help propel biotech startups and other small operations. The company is also investing in central Indiana’s workforce by partnering with Franklin College to give Hoosier students the opportunity to receive hands-on experience through internships in applied biotechnology.

“Franklin is pleased to have B2S in our dynamic downtown. We look forward to seeing them expand and bring more economic diversity to our city,” said Franklin Mayor Steve Barnett.

The IEDC offered B2S up to $250,000 in conditional tax credits based on the company’s job creation plans. These tax credits are performance-based, meaning until Hoosiers are hired, the company is not eligible to claim incentives. This project was supported by the Johnson County Development Corporation and received grant funding and other tax incentives from the Franklin Development Corporation and Franklin Redevelopment Commission.

“This project gives B2S the opportunity to invest in highly skilled talent and jobs quicker than we would be able to achieve otherwise. Together, the state of Indiana, IEDC and city of Franklin have created an environment where small businesses can grow and prosper, allowing for quality of life improvements and business diversification in the region,” said Aleks Davis, chief executive officer at B2S.

Biotech companies like B2S are choosing to locate and grow their operations here because of Indiana’s reputation as a global leader in the life sciences industry. According to BioCrossroads and the Indiana Business Research Center, Indiana is the second largest exporter of life sciences products in the U.S. at $8.2 billion in total exports. More than 1,600 life science companies operate in the state, supporting more than 55,000 Hoosier jobs with average wages of nearly $95,000 annually.

About B2S Life Sciences
B2S Life Sciences LLC is a customer-focused biotherapeutic enablement company located in Franklin, Ind. The company sepecializes in bioanalytical consulting, immunoassay development, custom biological reagent generation and life-cycle management (LCM), immunogenicity cut point analysis, PK/TK statistics and advanced analytics. For more information about B2S, visit www.b2slifesciences.com.

About IEDC
The Indiana Economic Development Corporation (IEDC) leads the state of Indiana’s economic development efforts, helping businesses launch, grow and locate in the state. Governed by a 15-member board chaired by Governor Eric J. Holcomb, the IEDC manages many initiatives, including performance-based tax credits, workforce training grants, innovation and entrepreneurship resources, public infrastructure assistance, and talent attraction and retention efforts. For more information about the IEDC, visit www.iedc.in.gov
– 30 –
Media Contacts: 
Garrett Sheets (B2S Life Sciences) – 317.787.2213 or pr@B2SLifeSciences.com
Abby Gras (IEDC) – 317.232.8845 or agras@iedc.in.gov

February 2018 Life Sciences Luncheon – 2018 Public Policy Overview

February 27, 2018

Public policies are impacting the life sciences sector dynamically, with many changes at the state and federal levels targeting manufacturers. Please join us as we hear the latest on the 2018 session of the Indiana General Assembly and delve into current public policy issues for the medical device and bio-pharmaceutical sectors. This month’s program will feature an Indiana legislative leader sharing thoughts on the current session and the direction state policy makers are heading in support of innovation. This will be followed by a moderated discussion featuring local industry leaders. This is a great time to reach out – please invite your legislators to attend with you!

 

 

PANELISTS
Anne HathawayExecutive Director, Indiana Medical Device Manufacturers’ Council (IMDMC)
Michael O’ConnorSenior Director, State Government Affairs, Eli Lilly and Company
MODERATOR
Kristin JonesPresident and CEO, IHIF

 

About the Series: The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in the life sciences. Each month, at lunch, a policymaker or a panel in the field of life science will be available to answer questions concerning the major challenges and opportunities in the industry. We hope you will join us.

 

To learn about upcoming lunch programs, please visit us on-line.

Hollingsworth Passes Bill to Cut Red Tape, Help Hoosier Companies Making Life-Saving Breakthroughs

February 15, 2018
FOR IMMEDIATE RELEASE Contact: Katie Webster
February 14, 2018 (202) 225-5315
 

 

WASHINGTON, D.C. – Today, the U.S. House of Representatives passed H.R. 1645, the Fostering Innovation Act, introduced by Rep. Trey Hollingsworth (R-IN) and Rep. Krysten Sinema (D-AZ), as part of a bipartisan legislative package to provide financial regulatory relief to Americans. H.R. 1645 helps ensure that costly regulations don’t stand in the way of successful biopharmaceutical research.

 

“This country has led the world in biotechnology innovation, successfully pushing limits to find cures for some of the deadliest diseases,” said Representative Hollingsworth. “The Fostering Innovation Act will right-size the regulatory environment that detracts from advancements, enabling America to develop the next generation of cures to combat illnesses that plague Hoosiers.”

 

Read the full text of the legislation, here.

 

The bioscience and biotechnology sector in Indiana has expressed strong support of the Fostering Innovation Act:

 

Kristin Jones, President and CEO, Indiana Health Industry Forum: “While the Fostering Innovation Act will be of broad benefit to companies in the bioscience sector across the country, Hoosier companies and patients also stand to benefit.  By eliminating a costly administrative burden, pre-revenue biotech companies will be able to focus more of their scarce investment funding on developing new therapies and adding high-wage jobs, instead of paying for expensive internal audits.  As more Indiana bioscience companies mature and look to IPOs as a viable fundraising option, we expect the benefits of the Act to accrue quickly.  We commend Rep. Hollingsworth for his leadership on this issue.”

 

Jeff Schwegman, Ph.D., Founder & CEO of AB BioTechnologies, Inc. (Bloomington, IN): “The Fostering Innovation Act eliminates the costly burdens of extensive audits to many of our clients, allowing them to invest further in drug development in Indiana. Ultimately these savings will be passed on to patients which benefits the community as a whole. Thanks to Representative Hollingsworth’s depth of understanding of the life sciences sector in Indiana, he was able to pass meaningful legislation that will provide a benefit to Hoosiers at all levels.”

 

 

Background

 

Currently, emerging growth companies (EGCs) are exempt from certain regulatory requirements for the first five years after their IPO.  One of the requirements EGCs are exempt from is Sarbanes-Oxley Section 404 (b) – which requires public companies to obtain an external audit on the effectiveness of their internal controls for financial reporting.  This reporting requirement is both costly and unnecessary because management is still required to assess internal controls, and these EGCs have limited public exposure.

 

H.R. 1645 is a narrowly-tailored fix that temporarily extends the Sarbanes-Oxley Section 404(b) exemption for an additional five years for a small subset of EGCs with annual revenue of less than $50 million and less than $700 million in public float. This legislation does not prohibit an external audit if the company or the majority of shareholders determine an audit is benefit.

 

 

 

# # #

 

 

 

Office of Representative Trey Hollingsworth  |  1641 Longworth House Office Building, Washington, DC 20515

P: (202) 225-5315 |  www.hollingsworth.house.gov

Announcing Genes in Space 2018

February 5, 2018
Design and Launch your DNA Experiment to Space!

 

Calling all students in grades 7 through 12: Pioneer research on the International Space Station by designing your DNA experiment for space. Genes in Space is a science contest that challenges students to design original DNA experiments that address real-life challenges and opportunities of space exploration. The contest is free, and does not require equipment. Proposals will be judged solely on their creative and scientific merit. The winning experiment is conducted in space, and samples are returned to Earth for you to analyze!

Submission deadline is April 20th, 2018

Genes in Space is a collaboration between miniPCR and Boeing with generous support from CASIS, Math for America, and New England Biolabs, Inc.
Learn More

For IHIF Members: Request a FREE cost savings program analysis

February 5, 2018
BBS 2012
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Your first step in 2018 can be accessing deep savings on business and lab essentials through BIO Business Solutions®. Request a FREE cost savings program analysis and we’ll review which programs and benefits would be the best fit for your company!
As the largest cost-savings purchasing program for the life sciences industry, BIO Business Solutions® aggregates the purchasing power of over 3,400 life science companies to deliver savings from more than a dozen leading suppliers-at no charge to you.

You also don’t have to change the way you do business to enjoy the BIO discounts and other benefits. The individual cost-savings programs do not restrict your purchasing selection to a short list of obscure “close out” items. In most cases, the full selection of products and services offered by a BIO Business Solutions® supplier are available to you at a discounted price.

Enrollment is quick and easy!
Visit bio.org/bbs/programs to learn more about the savings and services available to you.
 
Learn More
IHIF Members have access to a wide range of savings and discount programs offered exclusively through BIO Business Solutions and BIO’s state affiliate network.  Learn more here
About BBS

Apexian Pharmaceuticals Opens Phase 1 Clinical Study of APX3330 in Patients with Solid Tumors

January 24, 2018

Apexian Logo Font

 

FOR IMMEDIATE RELEASE

Indianapolis, IN – January 24, 2018 – Apexian Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced the opening of a clinical trial for patients with advanced solid tumors. The study involves APX3330, a first in class orally administered inhibitor of APE1/Ref 1, a dual-function protein that plays a critical role in promoting and maintaining a broad variety of cancers. Details of the study, including eligibility criteria, the location of participating clinical centers and referral contact information can be found at www.ClinicalTrials.gov, a website maintained by the National Institutes of Health.

 

The APE1/Ref-1 protein regulates the activity of other cancer-associated proteins, including transcription factors HIF-1-alpha, AP-1, NF-kappa B, and STAT3; proteins that control the aggressiveness of many cancers. Data indicates that Apexian’s drug APX3330 inhibits the cancer-promoting activity of APE1/Ref-1 without causing the side effects normally associated with many types of chemotherapy. Additionally, in a variety of pre-clinical studies APX3330 has been shown to not only have an anti-cancer effect, but to also prevent, and reverse the nerve damage caused by certain forms of chemotherapy.

 

The clinical study is the first to explore APX3330 use in patients with advanced cancer, and is the culmination of extensive research on APE1/Ref-1 and APX3330 conducted by Dr. Mark Kelley, Professor of Pediatrics and Associate Director of Basic Science Research at Indiana University’s Simon Cancer Center as well as other scientists worldwide. Dr. Kelley’s work on APE1/Ref-1 and APX3330 has previously resulted in significant research grants provided through the National Cancer Institute in order to explore APX3330’s potential to benefit cancer patients.

 

According to Dr. Richard Messmann, Apexian’s Chief Medical Officer, “Apexian’s research has provided us with a clear path to understanding, and an ability to measure, the clinical benefit that may be obtained when cancer patients are treated with APX3330. It also lays the foundation for determining whether patients with chemotherapy-induced peripheral neuropathy (CIPN) may benefit when receiving APX3330. The clinicians involved in the study, including those at the Simon Cancer Center and at START SA (San Antonio, TX) and START Midwest (Grand Rapids, MI) have uniformly expressed excitement regarding their participation in the study.”

 

“The initiation of the APX3330 study is a significant step forward in Apexian’s mission to develop safe and effective treatments for cancer patients,” said Steve Carchedi, President and CEO of Apexian Pharmaceuticals. “Despite recent advancements in cancer treatments, there continues to be a need for treatments that improve the survival of cancer patients. Apexian is committed to ‘moving mountains’ to help these patients.”

 

 

About Apexian Pharmaceuticals

Apexian Pharmaceutical’s mission is to develop safe and effective therapy for patients with high unmet medical needs.  Apexian’s lead drug candidate is APX3330, with additional promising agents in their drug-development pipeline. To learn more about Apexian Pharmaceuticals, please visit the company’s website at http://www.ApexianPharma.com

 

Media Contact:  Steve Carchedi

Email: PR@Apexianpharma.com, Telephone: 844-463-3330 x113