FAST BIOMEDICAL COMPLETES SUCCESSFUL PHASE II TRIAL; RESEARCH FEATURED IN PEER-REVIEWED PUBLICATION CARDIORENAL MEDICINE

Carmel, IN, March 26, 2019 — FAST BioMedical announced today the recent publication of their Phase II clinical trial data on Plasma Volume (PV) measurements in CardioRenal Medicine.

The company’s globally-patented, first-in-class technology directly measures blood volume and kidney function in a clinically-actionable way, which has the potential for profound impact on the care of heart failure, cardio-renal, major surgery, sepsis, critical care, and kidney disease patients. Each year more than 35 million hospitalizations worldwide would benefit from a plasma volume measurement.

The study was conducted at two sites in the U.S. in healthy subjects and patients with varying levels of chronic kidney disease. Included in the study was a measurement of how healthy subjects handled the administration of a volume challenge as evaluated by FAST’s Plasma Volume technology. The primary and the secondary endpoints of pharmacokinetics, safety and accuracy were achieved.

Highlights of the Phase 2 Trial results:
 The FAST injectable proved to be safe and well tolerated.
 The FAST PV technology delivered clinically meaningful results as demonstrated by its ability to stratify patients into the appropriate clinical group.
 The FAST injectable distributes in a manner consistent with the vascular volume and the PV marker remains stable in the vasculature for a period of at least 6 hours, allowing repeat measurements of PV during that time period without re-dosing.
 The FAST PV technology responded precisely and proportionally to a volume challenge given in healthy subjects.
 The technology displayed excellent reproducibility

“I am very pleased with the excellent accuracy and repeatability the FAST BioMedical technique to quantify plasma volume has shown. The demonstrated ability to closely track a fluid challenge is especially compelling. This technology can allow the clinician to have new understanding for both diagnosis and therapy. Congestive heart failure, sepsis and acute kidney injury are conditions where the value of an accurate PV is critical to understand. However, other difficult to diagnose and manage diseases such as hyponatremia, hypertension and chronic kidney disease also will benefit from the test,” stated Bruce A. Molitoris, M.D., FASN, FAST BioMedical’s medical director and co-founder and professor of medicine at Indiana University, and a lead author of the report.

FAST BioMedical’s Plasma Volume measurement technology is being developed to address the shortcomings of the current clinical standard of care for patients with volume instability. In patients presenting with the potential of volume abnormalities, an accurate determination of volume status is critical for appropriate diagnosis and management. Unfortunately, volume assessment is challenging. Current misdiagnosis rates are high and existing standard of care methodologies lack an accurate quantitative measurement. Less accurate indications of volume status have potential negative impact on medical outcomes.

FAST BioMedical’s technology has the potential to provide a clinician with a PV measurement as quickly as 30 to 45 minutes, and provide updated measurements for up to six hours. This allows for the
evaluation of volume changes impacted by clinical treatment, throughout that time. The technology uses a patented fluorescent injectable that works in concert with a patented measurement device.

“There is currently no technology in clinical care that can quickly and easily provide an accurate plasma volume measurement. The FAST BioMedical Technology has the potential to provide this, and, is an advantage for all types of patient care. For example, the management of congestive heart failure patients could be greatly improved by having such a tool,” said Co-author, FAST BioMedical Medical Advisory Board Member and Associate Chief of Emergency Medicine Research at Baylor College of Medicine Dr. Frank Peacock.

CardioRenal Medicine, a peer-reviewed medical journal, recently published a research article on FAST’s Plasma Volume technology. The full article can be found via https://www.karger.com/Article/FullText/496480

FAST BioMedical also had an additional peer-reviewed paper published in the Journal of the American Society of Nephrology (JASN). The publication highlighted FAST’s kidney function data from a successful Phase 2 clinical study. The FAST technology demonstrated impressive measurement accuracy via a high correlation (99%) to the research gold standard. The full article can be found via https://jasn.asnjournals.org/content/29/6/1609.abstract

In January 2019, FAST BioMedical was highlighted in the American Association of Kidney Patients (AAKP), RENALIFE Magazine as its featured Innovation.

About FAST BioMedical
FAST BioMedical is a privately held, late clinical-stage medical technology company based in Carmel, Indiana. The company’s globally-patented, first-in-class technology directly measures blood volume and kidney function in a clinically-actionable way. This has the potential for profound impact on the care of heart failure, cardio-renal, major surgery, sepsis, critical care, and kidney disease patients. The company has been financially supported by the NIH, Elevate Ventures, the Indiana 21st Century Fund, Rose-Hulman Ventures, BioCrossroads, Indiana University Medical Group, The Purdue Foundry Fund, Ellipsis Ventures, VisionTech Partners, and private single family office investors. The FDA has determined the company’s technology met the requirements for an Expedited Review. These products are investigational and not yet approved for human use.

Patented drug therapy for lung condition has been exclusively optioned to Theratome Bio

Proteins from adult stem cells might reduce inflammation caused by Acute Respiratory Distress Syndrome

FOR IMMEDIATE RELEASE

Feb. 11, 2019

 

INDIANAPOLIS — A patented Indiana University School of Medicine discovery that uses proteins, lipids and nucleic acids secreted by adult stem cells to treat Acute Respiratory Distress Syndrome, or ARDS, has been optioned to Theratome Bio, an Indianapolis-based life sciences company.

One of the symptoms of ARDS is a buildup of fluid and severe inflammation in the lungs, which impairs their ability to exchange oxygen and carbon dioxide. More than 200,000 people in the U.S. are affected by ARDS each year, and the mortality rate is approximately 40 percent.

The patented IU discovery uses the secretome from the stem cells as a biologic therapeutic to reduce the inflammation and buildup of fluid in the lungs. The IU Innovation and Commercialization Office exclusively optioned the treatment to Theratome Bio, which is building a portfolio of therapeutics based on the secretome of stem cells.

Michael Coleman

Michael Coleman, president and CEO of Theratome Bio, said: “There is no effective pharmacotherapy for ARDS. Mechanical ventilation is the standard of care, and innovation aimed at improving effectiveness and reducing ventilator-induced lung injury is ongoing. But mechanical ventilation does not address the underlying physiologic causes of ARDS.

“The IU School of Medicine innovation, discovered by Dr. Keith March — who serves as Theratome Bio’s chief medical officer — has the potential to treat ARDS by reducing inflammation, enhancing bacterial clearance and restoring capillary barrier function.”

Coleman said the cell-free therapy is easier to manufacture and store than using cells, which have shown benefit in early-stage clinical trials. The cell-free approach also offers defined potency and immediate bioavailability. It presents a therapeutic more consistent with a traditional pharmaceutical model than does using live cells.

“Developing this ARDS therapy aligns with Theratome Bio’s development plan to target acute treatments with a high medical need,” Coleman said. “Our next step to develop the work is performing further studies to confirm dosing levels and manufacturing needs for clinical trials.”

About Indiana University Innovation and Commercialization Office

Indiana University ICO is tasked with the protection and commercialization of technology emanating from innovations by IU researchers. Since 1997, IU research has generated almost 3,200 inventions resulting in more than 4,800 global patent applications. These discoveries have generated more than $145 million in licensing and royalty income, including more than $115 million in funding for IU departments, labs and inventors.

 

Media Contact

Steve Martin

IU Communications

Phone: 317-278-1505 | Email: stgmart@iu.edu

Apexian Presents at ASCO Palliative Care Meeting

FOR IMMEDIATE RELEASE – 

Apexian Pharmaceuticals presents data on their lead drug for anti-chemotherapy-induced peripheral neuropathy (CIPN), APX3330, at ASCO Palliative Care and Symptom Management meeting

 

Indianapolis, IN – December 5, 2018 – Chemotherapy causes chemotherapy-induced peripheral neuropathy (CIPN) in a significant number of patients, yet the pharmaceutical landscape is completely devoid of treatments to prevent CIPN. The tingling, burning, pain or numbness in the extremities can limit or stop cancer treatment. And, in half the patients affected, CIPN’s symptoms persist five years or more after treatment ends. Apexian Pharmaceuticals aims to change that with their lead compound, APX3330.

 

Data presented at the meeting showed continued preclinical support for APX3330 as a potential anti-CIPN treatment, particularly for patients treated with cisplatin or oxaliplatin. Preclinical results presented show APX3330 can block tumor growth while protecting nerve cells.

 

APX3330, an oral treatment, is currently in a Phase I oncology trial for safety. A Phase II trial is planned in 2019 for anti-tumor and anti-CIPN.

 

Apexian’s founder and Chief Science Officer, Mark Kelley, PhD, presented the trial’s results in ASCO’s Symptom Management Meeting in San Diego, November 16-18, 2018.

 

Currently ASCO does not recommend any drug for preventing or treating CIPN.

 

“CIPN is a disease with high unmet need and it is exciting to see that APX3330 may have a role to play in addressing the need, says Steve Carchedi, President & CEO of Apexian”. “We are committed to developing a portfolio of novel APE1/Ref-1 compounds that will enhance the lives of patients”.

 

The success of APX3330 builds upon three decades of research by Kelley and his colleagues in modulating a key DNA repair protein, APE1/Ref-1. APX3330 tweaks the protein’s activity to prevent or repair neuronal damage without stimulating cancerous tumors.

 

APX3330 is Apexian’s lead compound in its growing drug development pipeline.

 

About Apexian Pharmaceuticals

Apexian Pharmaceuticals is a patient-centered biotechnology company dedicated to developing novel anti-cancer compounds that target the multiple functions of the APE1 protein. Apexian’s research is grounded and driven by the belief that “better is always possible.” Please visit www.ApexianPharma.com for more information.

 

Media Contact:

Email: PR@Apexianpharma.com

Roger D. Miller, COO

Telephone: 844-463-3330 x100

Waters has acquired DESI 2D from Prosolia

Today, July 23, 2018, Waters Corporation (NYSE: WAT), Prosolia, Inc. and the Purdue Research Foundation (PRF) announced that Waters® acquired exclusive rights to Desorption Electrospray Ionization (DESI) technology for all mass spectrometry applications from Prosolia and PRF.

“The acquisition of DESI technology bolsters Waters’ portfolio of mass spectrometry imaging innovations, a rapidly expanding MS technique for biomedical research and related applications,” said Chris O’Connell, Chairman and Chief Executive Officer, Waters Corporation. “DESI mass spectrometry imaging provides complementary and actionable data when compared to classical histopathology imaging technologies with major advantages in analyzing the molecular fingerprint within a sample, thus delivering deeper biological insights. Ultimately, these insights will lead to better understanding of disease and enable the development of new, more effective medical therapies.”

“We at Prosolia are proud of our role in developing and commercializing DESI technology,” said Justin Wiseman, Chief Executive Officer, Prosolia. “The potential for MSI analysis using DESI technology is significant because of the quality of the data, the minimal sample preparation required, and the non-destructive nature of the technique allowing for multimodal analysis on a single sample.”

Waters will continue to support its customers who are already realizing the benefits of DESI technology with their Xevo™ and Synapt time-of-flight mass spectrometers. As the technology transitions from Prosolia to Waters, Prosolia will also continue to supply the DESI 2D technology for certain Thermo Scientific and Agilent mass spectrometer configurations until September 30, 2019. Prosolia will be responsible for and will continue to honor its warranty commitments made prior to Waters’ acquisition of the DESI technology to those scientists and organizations who currently have a DESI 2D source unit on any non-Waters mass spectrometer.

Read the full press release here.

FAST BioMedical’s Phase 2 Clinical Trial Results Published in the Prestigious Journal of the American Society of Nephrology

Posted May 18 2018 7:32 PM

Carmel, IN — May 18, 2018 — FAST BioMedical announced today the recent publication of their Phase 2 clinical trial data on kidney function measurement in the Journal of the American Society of Nephrology. The results were presented in an article entitled “A Novel Method for Rapid Bedside Measurement of GFR”.

The Phase 2 clinical trial assessed the safety and performance of the FAST technology. Performance was determined by comparing the FAST technology’s kidney function measurement (Measured Glomerular Filtration Rate or mGFR) to an iohexol clearance measurement methodology in patients with varying degrees of kidney function. Iohexol is a research methodology for accurate kidney function measurement. Iohexol is not FDA approved and is considered too cumbersome, with results too delayed, to be commercially viable.

The FAST technology demonstrated impressive accuracy via a high correlation to iohexol clearance. The per patient linear correlation to iohexol was greater than 99%. The FAST technology also demonstrated a strong safety profile and excellent repeatability.

“The results in this publication demonstrate that an accurate, safe, and clinically meaningful kidney function measurement is a major step closer to the patient.” said Dr. Bruce Molitoris, FAST BioMedical Medical Director and Co-Founder. “This technology has the potential to move us past the current poor estimations, to a clinically actionable answer for the individual patient.”

“The FAST technology was easy to use and can be comfortably translated to routine hospital protocols. It was well tolerated, and there were no serious adverse events,” said Dr. Dana Rizk, a nephrologist at University of Alabama at Birmingham Hospital, and one of the lead investigators for the trial. “This new technology has the potential to allow physicians to detect early kidney function loss and renal reserve, thus enabling earlier therapeutic interventions. In short, it opens the door to exciting new endeavors in the world of Nephrology.”

About FAST BioMedical

FAST BioMedical is a privately held, clinical-stage medical technology company in Carmel, Indiana. The company’s globally-patented, first-in-class technology directly measures blood volume and kidney function in a clinically actionable way. This has the potential for profound impact on care of heart failure, cardio-renal, major surgery, sepsis, critical care, and kidney disease patients. The company has been financially supported by the NIH, Elevate Ventures, the Indiana 21st Century Fund, Rose-Hulman Ventures, BioCrossroads, Indiana University Medical Group, The Purdue Foundry Fund, Ellipsis Ventures, VisionTech Partners, and private single family office investors. The FDA has determined the company’s technology met the requirements for an Expedited Review. These products are investigational and not yet approved for human use.

For more information, please visit www.FASTBioMedical.com

Indigo BioAutomation, Inc. Receives ISO 13485:2016 Certificate

Indigo’s Quality Management System demonstrates excellence by obtaining an ISO 13485:2016 certificate

Friday July 20^th, 2018

Carmel, IN – Indigo BioAutomation, Inc. (Indigo), a leading provider of software solutions for laboratory automation, announced today that it has received an ISO 13485:2016 certificate from British Standards Institute (BSI) Group. This certificate demonstrates the organization’s ongoing commitment to providing the highest quality medical device solutions, products, and services to its customers. Indigo previously held ISO 9001:2008 certification.

 

The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. ISO 13485:2016 identifies the requirements for a medical device focused quality management system to ensure an organization has the ability to consistently meet both regulatory and customer requirements.

 

“This certification is a testament to the high level of performance and quality control we expect at Indigo BioAutomation during the development, production and support of our software,” commented Randall Julian, President, Founder and CEO of Indigo. “This level of rigor is important to ensuring our software continues to provide accurate, reliable, and reproducible results for our customers.”

 

Indigo registered with FDA and listed their flagship product, ASCENT^™, as a class I exempt medical device in September of 2017.

 

“Receiving this ISO13485:2016 certificate strongly reflects Indigo’s commitment to quality as well as our ability to bring safe and effective products to the market,” said Brian Huff, Director of QA/RA for Indigo. “This certificate also demonstrates Indigo’s drive to raise the level of quality throughout the organization and satisfy a very rigorous standard for medical device quality systems in an innovative manner.”

 

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

April 25, 2018

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

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

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. 
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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

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

 

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