Saladax is Awarded “Best Poster Presentation” for Study on Individualized Dosing of Paclitaxel

Bethlehem, PA, October 10, 2017 -- Saladax Biomedical, Inc., recently presented a study on the value of adjusting paclitaxel doses.  The results show that serious side effects such as neutropenia, and neuropathy are greatly reduced when oncologists personalize each patient’s chemotherapy dose using a simple blood test.  “Open-Label Randomized Study of Individualized Pharmacokinetically (PK) – Guided Dosing versus Body Surface Area (BSA) Dosing of Paclitaxel (PTX) in Advanced Non-Small Cell Lung Cancer (NSCLC)” was presented at two conferences: the European Society for Medical Oncology (ESMO), and the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT).  At IATDMCT Saladax received the Best Poster Award based upon the study’s originality, significance, scientific and technical challenges, and presentation.  The study was conducted in China by investigators at the Department of Oncology at Shanghai Pulmonary Hospital.  Saladax’s MyPaclitaxel assay (licensed to Fosun Long March) was used to measure the level of drug in the patients’ blood.

 

ESMO is the most prestigious and influential oncology organization in Europe, respected by healthcare professionals, key opinion leaders, and patient advocacy associations..

 

IATDMCT is the organization that promotes therapeutic drug monitoring and clinical toxicology worldwide. Therapeutic drug monitoring or PK-guided dosing maximize a drugs’ clinical and economic benefits to patients.

 

Paclitaxel (PTX) (Taxolâ) is commonly used to treat several cancers, including ovarian cancer, breast cancer, and non-small cell lung cancer.  The current study expands on previously published works, demonstrating that dosing by measuring drug in a patients’ blood is superior to the current practice of dosing by Body Surface Area (BSA), because it improves outcomes by lowering toxicity, such as neuropathy and neutropenia, without impacting efficacy.1

 

The presentation was on a large, two-arm, randomized study; with a total of 275 patients. [JC1]  Levels of paclitaxel in blood showed that patients dosed by BSA were over-exposed to PTX.  Patients in the dose-adjusted/individualized arm had their doses lowered based on the results of the paclitaxel blood test.  Patients in the BSA arm did not have their doses adjusted, except for toxicity.  Of those who received individualized dosing (PK-guided/TDM), 96% received lower doses in cycle 4 compared to cycle 1.2Dose reduction resulted in a statistically significant lowering of the relative toxicity in the individualized dosing arm compared to the BSA arm: 38% reduction in grade 4 hematological toxicity, 34% reduction in severe neutropenia, and a 53% reduction in neuropathy grade ≥ 2.  While lower toxicity could be expected with reduced doses, the efficacy of the regimen was not impacted.  The study demonstrates that using blood levels to individualize dosing (TDM), chemotherapy can be personalized to reduce neutropenia and neuropathy while still maintaining or improving efficacy.

 

“More and more studies are being reported that show the benefits of TDM, and we hope that more oncologists will use this tool to improve patient care” stated Dr. Salamone, CEO and President of Saladax, at the ESMO Conference.  “This study demonstrated the superiority of individualized patient dosing compared to standard BSA dosing methods.”

 

About Saladax Biomedical, Inc.

 

Saladax Biomedical is a leader in the development and deployment of high-quality diagnostic services and products, delivering data to help physicians select and optimize the use of current and new pharmaceutical products, to accelerate improvements in battling disease and positively impact the economics of care because… no two patients are alike.

 

Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified.  For more information visit Saladax.com

 

1.     Joerger M, et al. Ann Oncol. 2016; 27(10): 1895-1902

2.     www.saladax.com

 

 [JC1]Too technical?

Saladax Licenses Alzheimer’s Diagnostic Tests to Siemens Healthineers

Tests can lead to early identification of Alzheimer’s Disease

Bethlehem, PA--(BUSINESS WIRE)--January 18, 2017-- Saladax Biomedical, Inc., a privately held company focused on precision in-vitro diagnostic tests, announced today that it has signed an agreement to license diagnostic tests for Alzheimer’s disease (AD) to Siemens Healthineers. Saladax’s tests identify the amyloid beta 1-42 and tau biomarkers in cerebrospinal fluid (CSF) which are known and accepted biomarkers for AD.

Alzheimer’s Disease is currently the sixth leading cause of death in the U.S., affecting nearly 50 million patients worldwide, with 10 million new cases each year. Presently, no disease-modifying therapeutics exist, and the available drugs provide limited alleviation of symptoms. The use of tests to identify CSF biomarkers much sooner than previously available, will give clinicians the ability to more accurately identify AD and begin treatment sooner. Early detection of AD is also an important step in better understanding the disease.

The two biomarkers have been extensively studied for over 20 years, and are key indicators of the early stages of Alzheimer’s disease. Currently, evidence of early AD can only be determined by PET (positron emission tomography) imaging equipment such as can be found with Siemen’s PETNET Solutions, or biomarkers such as Saladax’s amyloid beta 1-42 and tau tests.

“We are very excited to be working with Siemens Healthineers to bring these important assays to the market,” said Sal Salamone, Ph.D., CEO of Saladax Biomedical, Inc. “Siemens is an ideal partner with a strong global position and high quality instrumentation.”

Under this non-exclusive agreement, Saladax will provide its proprietary raw materials, protocols, and intellectual property and Siemens will be responsible for the commercialization of both assays.

About Saladax Biomedical, Inc. Saladax Biomedical is a leader in the development and deployment of high-quality diagnostic services and products to help physicians select and optimize the use of current and new pharmaceutical products, to improve treatment and positively impact the economics of care… because no two patients are alike.

Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified. For more information visit: www.saladax.com.

Salvatore J. Salamone, Ph.D., Founder and CEO of Saladax Biomedical, Inc. Inducted into the New Jersey Inventors Hall of Fame

Bethlehem, PA., October 28, 2016  Saladax Biomedical, Inc., the leader in developing oncology diagnostics that increase the impact of personalized medicine, announced today that Dr. Salvatore J. Salamone, the Company's Founder, President, and Chief Executive Officer has been inducted into the New Jersey Inventors Hall of Fame. Salamone is being honored for: "Luminary discoveries and contributions in the fields of oncology research, therapeutic diagnostics, health care and medical device services."  The award was presented at an award ceremony on Thursday, October 27, 2016.

Dr. Salamone has over 30 years of experience developing diagnostics. He is recognized globally in the field of drug monitoring, and has published extensively in this area. Dr. Salamone has been awarded 41 US Patents and over 100 foreign patents. These patents serve as the fundamental basis for the products launched at both Roche and Saladax. The accumulated sales of these products have exceeded $1 billion.

Dr. Salamone co-founded Saladax in an effort to meet a need in the oncology community; developing diagnostics for oncologists to dose patients correctly.  With pharmaceutical companies placing greater emphasis on personalized medicine, Saladax has become a leader in oncology with tests that ensure patients are receiving the correct dose of chemotherapy.

“We will not fully achieve the promise of personalized medicine until we also ensure patients are receiving the correct amount of drug for their body” said Dr. Salamone. “This is my life’s work and I am deeply honored to be recognized for it.”

Dr. Salamone grew up in Central New Jersey and graduated from J.P Stevens H.S.in Edison. He attended Villanova University where he received his BS degree and returned to NJ to earn M.S. and Ph.D degrees in chemistry at Rutgers University. While at Rutgers, he served on the Rutgers University Board of Trustees, received the Graduate Student award for Research Excellence, as well as the Charles A. Sabbath and the Martin H. Freedmen awards in Chemistry. After graduating Dr. Salamone received a fellowship to study at Oxford University. One day while at Oxford he received a telegram from Roche Diagnostics asking him to consider a position in this growing division on the Nutley NJ campus. He accepted the position and began his tenure at Roche in 1984. As Roche Diagnostics became the world’s largest diagnostic company Dr. Salamone was promoted to Vice President and headed US R&D activities for the Laboratory Systems Division. Dr. Salamone left Roche in 2001 and served as Senior Vice President of R&D for Orasure Technologies before founding Saladax Biomedical, Inc.

"I am humbled to be receiving this award along with so many other talented individuals who are improving our lives through innovation," Salamone said. "I am proud to have lived in the only state to have its own Inventors Hall of Fame, and overwhelmed to be included with some of the great innovators, like Leo Sternbach and Thomas Edison.”

Dr. Salamone attributes much of his success to a supportive family, outstanding colleagues and a corporate environment that celebrated creative achievement.

Now in its third decade, the New Jersey Inventors Hall of Fame is supported by the Office of Innovation & Entrepreneurship at Stevens Institute of Technology and the law firm of Greenberg Traurig, LLP.

About Saladax Biomedical, Inc.

Founded in 2004, Saladax Biomedical, Inc. is a privately held company headquartered as an anchor tenant with Ben Franklin Technology Partners in Bethlehem, Pennsylvania. Saladax develops novel blood tests to increase the impact of personalized medicine by bringing chemotherapeutic drug monitoring to oncologists. Saladax believes that truly personalized medicine can only exist when the right drug is given at the right dose.

For more information, visit www.Saladax.com.

 

 

Study Shows That Therapeutic Drug Monitoring Can Reduce Paclitaxel-Associated Neuropathy

Bethlehem, PA, October 20, 2016 Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic tests, today announced the publication (Joerger et al. Ann. Oncol. 27: 1895-1902, 2016) of a practice changing study that shows the benefits of measuring and adjusting the amount of chemotherapy in a patient’s blood to minimize neuropathy an often debilitating toxicity of paclitaxel.  This process of measuring and adjusting drug doses to reach a target is commonly called Therapeutic Drug Monitoring (TDM).  The report concluded that those patients whose paclitaxel treatment was measured and adjusted had reduced paclitaxel-associated neuropathy which improved the benefit-risk profile in patients with advanced NSCLC.

Chemotherapy induced peripheral neuropathy (CIPN) is a frequent and often debilitating side effect of some chemotherapy and is often the reason why patients drop out of treatment. It can cause severe pain or loss of feeling among other symptoms and become permanent.  There is no treatment for this kind of neuropathy, which is why the results of the paclitaxel TDM study are so important.  When patients received the right dose of paclitaxel, severe neuropathy was significantly reduced – by 78 percent. TDM of anticancer drugs can help reduce the toxicity in patients undergoing chemotherapy; which results in fewer trips to the hospital, fewer adverse effects, and an overall improved quality of life while undergoing treatment.

“The implications of these findings are far-reaching,” said Salvatore Salamone,Ph.D. President and CEO of Saladax. “We’ve long known that giving cancer patients the right dose of chemotherapy is critical to better outcomes and lower toxicity. We will not fully achieve the promise of personalized medicine unless we are able to dose drugs properly – TDM gets us closer.”

Currently, most cancer patients are administered chemotherapy based on Body Surface Area (BSA). This method dates back to 1916 and is not consistent with current scientific knowledge. The BSA, one-size-fits-all, way of dosing cancer patients is inaccurate and leads to a great deal of variability. Too much drug can lead to adverse side effects while too little may be ineffective in treating the cancer.  Dosing that is closely measured through a simple blood test will tell the oncologist what is happening to the drug in a specific patient so that the dose can be adjusted to the right level.. Getting the dose just right in each patient is what TDM is all about.

“More and more  studies are being reported that show the benefits TDM  and we hope that more oncologists will use this tool a to improve patient care” added Dr. Salamone. “This study demonstrated the superiority of individualized patient dosing compared to standard dosing methods.”

About Saladax Biomedical, Inc.

Saladax Biomedical is a leader in the development and deployment of high-quality diagnostic services and products, delivering actionable data to help physicians select and optimize the use of current and new pharmaceutical products, with the goals of improving health and positively impacting the economics of care… because no two patients are alike.

Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified. For more information visit: www.saladax.com

 

 

Saladax’s New Website: User-Friendly for Oncologists, Pathologists, Patients

Saladax is Advancing Personalized Therapeutic Drug Monitoring for Chemotherapy

Bethlehem, PA – October 13, 2016 – Saladax Biomedical Inc., a provider of immunoassays for oncology, today unveiled its new company website at Saladax.com. With updated functionality and a new look and feel, Saladax Biomedical's website now features enhanced search capabilities, progressive user interface, and easily accessible information for oncologists, pathologists, researchers, laboratorians, distributors and patients. Saladax Biomedical stands at the forefront of therapeutic drug monitoring (TDM) in oncology. The new website offers great resources to support TDM.

“Saladax continues to look for ways to advance personalized medicine,” said Saladax CEO, Salvatore Salamone. “We hope our new website will provide a valuable resource for oncologists and patients to better understand the benefits of the right drug and the right dose. We will not fully achieve the promise of personalized medicine unless we are able to dose the drug properly.”

In addition to the updated website, Saladax recently expanded its contract research and companion diagnostics (CDx) capabilities. Saladax is well known for its ability to efficiently develop quality companion diagnostics for important pharmaceutical partners. Companion diagnostics advance and promote personalized healthcare by guiding therapy, predicting which patients are most likely to benefit from a particular therapy or which therapy could best be administered to an individual. The healthcare industry understands the wider benefits of a companion diagnostics test in delivering reduced healthcare costs and improved patient outcomes.

About Saladax

Founded in 2004, Saladax Biomedical, Inc. is a privately held company headquartered as an anchor tenant with Ben Franklin TechVentures® and client of the Ben Franklin Technology Partners of Northeastern Pennsylvania on Lehigh University’s campus in Bethlehem, PA. Saladax develops novel blood tests to increase the impact of personalized medicine by bringing chemotherapeutic drug monitoring to oncologists. Saladax believes that truly personalized medicine can only exist when the right drug is given at the right dose. Our diagnostic reagents and kits are distributed worldwide excluding the United States. Saladax is ISO 13485:2003 certified. For more information, visit www.Saladax.com.

Saladax Biomedical, Inc. Announces Presentation of CEPAC-TDM Study of Paclitaxel in Non-Small Cell Lung Cancer at 2015 ASCO Meeting

FOR IMMEDIATE RELEASE

Saladax Biomedical, Inc. Announces Presentation of CEPAC-TDM Study of Paclitaxel in Non-Small Cell Lung Cancer at 2015 ASCO Meeting

Large Study Confirms the Benefit to Patients of Advanced Dosing Method for

BETHLEHEM, Pa. -- June 8, 2015 Saladax Biomedical, Inc. recently presented results from the largest, randomized, prospective dose adjustment-therapeutic drug monitoring (TDM) trial ever conducted in oncology: evaluating 304 patients over six years (abstract # 8051). The Central European Society for Anticancer Research (CESAR) Study of Paclitaxel Therapeutic Drug Monitoring (CEPAC-TDM) phase III study in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (ClinicalTrials.gov Identifier NCT01326767) compared two different methods of dosing paclitaxel: one arm with dose optimization [pharmacokinetically (PK)-guided] to another arm with standard dosing. The results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015 taking place in Chicago, Illinois. The presentation is available on the Saladax website at www.saladax.com.
CEPAC-TDM was a study of paclitaxel (PTX) dosing in NSCLC patients receiving PTX in combination with carboplatin on a 3-weekly schedule. Standard dosing of chemotherapy does not account for the many differences between patients that make drug exposure highly variable, and variability of exposure can lead to severe toxicity and/or shorter survival.
Patients with advanced NSCLC receiving PTX/carboplatin chemotherapy were enrolled at nine German and one Swiss institution. In the PK-guided arm the majority of patients saw a significant reduction in the dose with fewer toxic side effects and the same survival as the standard arm. This well controlled, randomized study showed that using PK-guided dosing with 3-weekly PTX in NSCLC patients, results in a clinically significant reduction of both neutropenia and neuropathy compared to standard dosing. The reduction in neuropathy is particularly important because there are no known effective therapies to treat or prevent this often debilitating side effect. The lower average PTX doses only reduced toxicity and did not reduce efficacy, confirming the value of PK-guided dosing with chemotherapy patients.

At the same conference, interim results from a similar randomized study in NSCLC (ClinicalTrials.gov Identifier NCT02058433) reported from Shanghai Pulmonary Hospital in China revealed comparable findings, further demonstrating the value of PK-guided dosing (abstract # 8052).

About Saladax Biomedical, Inc.: Saladax Biomedical is a leader in the development high-value diagnostic services and products. Products that deliver actionable data to help physicians select and optimize the use of current and new pharmaceutical products to improve health and positively impact the economics of care: diagnostics that make a difference. Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified. For more information visit: www.saladax.com.

Saladax Contact:
Salvatore Salamone, Ph.D.
Phone: 610-419-6731
Email: ssalamone@saladax.com

Saladax Biomedical, Inc. Announces the Presentation of the CESAR Study Results for Pharmacokinetically-Guided Dosing of 5-Fluorouracil in Colorectal Cancer at 2015 ASCO Meeting

FOR IMMEDIATE RELEASE

Saladax Biomedical, Inc. Announces the Presentation of the CESAR Study Results for Pharmacokinetically-Guided Dosing of 5-Fluorouracil in Colorectal Cancer at 2015 ASCO Meeting

Advantages of a Practical Approach to Personalized Dosing of 5-FU Demonstrated

BETHLEHEM, PA, June 9, 2015 – Saladax Biomedical, Inc. recently presented results from the Central European Society for Anticancer Research (CESAR) study at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015 taking place in Chicago, Illinois. The presentation is available on the Saladax website at www.saladax.com.
Using the most common infusional 5-FU regimens to treat colorectal cancer (CRC), the CESAR study (clinical trial identifier: EUDRACT 2011-003553026) was conducted in seven centers in Germany. The study demonstrated that regardless of the regimen, standard dosing 5-FU using body surface area resulted in highly variable and unpredictable exposure, with the majority (65%) of CRC patients being under-dosed. Pharmacokinetically (PK) guided adjustment of 5-FU doses controlled individual patient exposure: after just two cycles the PK-guided dosing resulted in higher doses and significantly more patients achieving the optimal 5-FU exposure range. These results have been reproduced in several other studies done in Europe, the US, and China. When compared to historical data, personalization of dosing led to an overall lower incidence of toxicity, despite the higher doses being administered.

These findings verify the results from multiple studies demonstrating the importance of optimizing 5-FU therapy on a patient-by-patient basis to lower toxicity and improve efficacy. PK-guided dose adjustment makes it possible for more patients to achieve an effective 5-FU dose with less toxicity.

About Saladax Biomedical, Inc.:
Saladax Biomedical is a leader in the development high-value diagnostic services and products. Products that deliver actionable data to help physicians select and optimize the use of current and new pharmaceutical products to improve health and positively impact the economics of care: diagnostics that make a difference
Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified. For more information visit: www.saladax.com.
Saladax Contact:
Salvatore Salamone, Ph.D.
Phone: 610-419-6731
Email: ssalamone@saladax.com

Saladax Biomedical Announces U.S. Launch of MyImatinib™ Chemotherapy Exposure Optimization Test

Saladax Biomedical Announces U.S. Launch of MyImatinib™

Commercial Launch of MyImatinib™ Test Expands MyCare™ portfolio of Chemotherapy Exposure Optimization tests available from Saladax Biomedical Laboratories

Bethlehem, PA, December 1, 2014 – Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic tests, today announced the commercial launch of the MyImatinib™ test. MyImatinib is part of the Saladax line of MyCare™ diagnostic
tests that determine a patient’s exposure to chemotherapy in an effort to improve and personalize dosing.
The MyCare tests are simple blood tests that provide oncologists with specific information about each patient’s exposure to chemotherapy, helping the doctor to make informed decisions on drug dose adjustments, with the goals of maximizing the therapy’s effectiveness and limiting
its potential side effects. The MyImatinib tests will be managed through the Saladax Biomedical Laboratories (SBL), the CLIA-certified division of Saladax Biomedical.

“We’re very excited to expand our portfolio of chemotherapy tests to include MyImatinib,” said Kevin Harter, Chairman, President and CEO of Saladax Biomedical. “Our own analysis shows that, in general, 50% of patients are not receiving an optimal chemotherapy dosage which reduces the effectiveness of the treatment or causes significant toxicity.”
Imatinib is used in the treatment of multiple cancers, and is marketed in the United States by Novartis as Gleevec®. MyImatinib joins the Saladax portfolio of tests that currently include My5-FU™, MyPaclitaxel™ and MyDocetaxel™. The MyCare tests are designed to provide oncologists with accurate, convenient and reliable information regarding Imatinib exposure levels.
“MyImatinib enables oncologists to administer tailored, personalized doses to chronic myeloid leukemia and gastrointestinal stromal tumor patients, allowing for optimal drug exposure and adherence over the course of their treatment,” added Harter.
SBL anticipates expanding its menu of testing services to include more than a dozen new chemotherapy exposure optimization tests that Saladax Biomedical is currently developing.

About Saladax Biomedical, Inc.
Saladax Biomedical is a leader in the development and deployment of high-quality diagnostic services and products, delivering actionable data to help physicians select and optimize the use of current and new pharmaceutical products, with the goals of improving health and
positively impacting the economics of care… because no two patients are alike. Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified. For more information visit: www.saladax.com

Personalized Chemotherapy Tests Cleared for Use in China

Personalized Chemotherapy Tests Cleared for Use in China

Exposure Optimization Tests

Shanghai, China and Bethlehem, PA, July 23, 2014 – Fosun Diagnostics, a division of Fosun Pharmaceuticals, and Saladax Biomedical, Inc. today announced the launch of the MyCare™ portfolio of exposure optimization tests in China. Saladax Biomedical develops and markets MyCare diagnostic tests designed to customize chemotherapy dosing for patients.

Fosun Diagnostics is Saladax’s manufacturing, clinical and market development partner in China for the entire MyCare line.
MyCare assays are blood tests that provide oncologists with specific information about each patient’s exposure to a chemotherapy drug, helping the doctor to make informed decisions on dose adjustments. The goal of each blood test is to maximize the chemotherapy’s
effectiveness and limit potential side effects. MyCare is built upon the Saladax technology platform and extensive patent portfolio.
“China has a long established history of personalized medicine and these assays will give our healthcare providers a way to manage each patient individually, thereby allowing for the best possible outcomes as they battle cancer,” said Ted Zhu, CEO of Fosun Diagnostics Division.
“Our investment in, and partnership with Saladax, was for the specific purpose of bringing this kind of personalized cancer care to the people of China and we are pleased to begin making these diagnostic tests available.”
Fosun received CFDA clearance to market three MyCare assays - My5-FU™, MyPaclitaxel™, and MyDocetaxel™. Fosun will manage distributors and will work directly with large healthcare facilities and oncologists to make this technology available to the large Chinese market. Fosun imported the technology from Saladax Biomedical Inc. and it is currently CEmarked.

At present, these products are in clinical use in the United States, Japan, andEurope.
“The launch of Saladax’s MyCare tests in China represents an important milestone for Saladax,” said Kevin M. Harter, President and CEO of Saladax. “Fosun has been an excellent business partner in all respects, and we have high expectations for this market.”
The MyCare technology platform and product portfolio are in a leading position in the world.

Through continuous product research and development, the portfolio can cover up to 80%- 90% of the routine anti-tumor drug monitoring market. Fosun Diagnostics will maintain close cooperation with Saladax and develop more of the anti-tumor drug tests to meet the market demand in China.

About Saladax Biomedical, Inc.
Saladax Biomedical is a leader in the development and deployment of high-quality diagnostic services and products, delivering actionable data to help physicians to select and optimize the use of current and new pharmaceutical products, with the goals of improving health and
positively impacting the economics of care… because no two patients are alike.
Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified.
About Fosun
Fosun Pharma, based in Shanghai, is a leading healthcare company in China. Established in
1994, it has been listed on Shanghai Stock Exchange since August 1998. Fosun Pharma
develops, produces and distributes pharmaceuticals, healthcare services, diagnostic
products and medical devices.