Press Release

White Paper: Setting Up a Preclinical PET Imaging Lab

zr89-blog-header
Molecular imaging allows biological processes to be interrogated non-invasively in vivo. PET is a molecular imaging technology which utilizes radionucleotides to deliver high spatial and temporal resolution data. The G-Platform G4 PET/X-ray and G8 PET/CT systems from PerkinElmer removes many of the technical hurdles required for incorporation into preclinical imaging research. There are however many regulatory and safety requirements that must be met before your lab is approved to perform PET imaging studies.

This white paper outlines many key regulatory and safety considerations, as well as provide you with a list of materials to consider purchasing to setup your preclinical PET imaging facility.

Summary of White Paper

    Learn how to:

  • Integrate the G4 and G8 PET systems into current molecular imaging platforms with little or no lab renovations
  • Reduce exposure levels to researcher and the subject
  • Safely work with radioactivity by utilizing proper shielding, dosimetry/monitoring and workflow design
  • Properly outfit your PET imaging lab with safety and imaging supplies
White Paper
Setting up a Preclinical PET Imaging Lab
PET-lab-white-paperDownload PDF

SOFIE BIOSCIENCES receives $1.5M NCI Phase II SBIR

Original post: http://goo.gl/Li4BGt

CULVER CITY, Calif., Oct. 16, 2014 /PRNewswire/ — SOFIE BIOSCIENCES, a leader in the field of Positron Emission Tomography (PET) imaging, including probes, scanners, and chemistry systems, announced today that the National Cancer Institute (NCI) has awarded the company a Phase II Small Business Innovation Research (SBIR) contract for approximately $1.5M over two years. This contract will support the further development of SOFIE’s family of proprietary imaging probes, known as [18F]FAC, that measure the enzyme, dCK, which controls the rate of DNA production through the salvage pathway. Cancer drugs, like gemcitabine and others, use dCK to convert the drug into a pharmacologically active product that blocks the high rates of DNA replication for growth of malignant cells. One of SOFIE’s objectives with [18F]FAC is to use PET imaging to allow physicians to search throughout the body for tumors that will respond to drugs that target dCK, thus enabling more patient-specific treatment selection.

The key barrier in the commercial distribution of [18F]FAC, as well as other probes, comes from the production of the probes themselves. While commercially available radiochemistry systems do exist, they are restricted in terms of chemical reaction conditions and lack reliability and ease of use. These limitations make it impossible to widely produce [18F]FAC. Building on the success of SOFIE’s previous NCI Phase I SBIR, the Phase II contract will augment internal investment, allowing the company to move forward supporting multi-center clinical trials by creating a standardized manufacturing process through ELIXYS, the first ever three-reactor radiochemistry system for automated production of a diversity of probes.

“SOFIE believes that ELIXYS is the cornerstone in the development of a network of radiochemistry systems that seamlessly connect investigators across the US with the means to produce [18F]FAC for clinical trials. We imagine [18F]FAC as just the first in a line of extraordinary new PET probes that answer important questions about the biology of disease or to select the right therapy, and the ELIXYS network as the conduit to these probes becoming widely used,” said Patrick Phelps, President & CEO.

Dr. Melissa Moore, CTO and Principal Investigator, will work in close collaboration with sub award investigator, UCLA Professor Dr. R. Michael van Dam, to further this technology. “I’m very excited to be part of such an innovative project, and believe that there is a real need to speed up the process from early PET probe development to clinical trials. We’re so fortunate that the NCI believes both in the value of ELIXYS to help diversify the number of PET probes widely available for preclinical and clinical use and in the potential of [18F]FAC.”

PerkinElmer Partners with Sofie Biosciences to Deliver Benchtop PET In Vivo Imaging Systems to Preclinical Research Professionals

Preclinical PET Imaging Instruments in Benchtop Format Help Support High Performance Disease Research, Drug Discovery and Clinical Translational Applications

WHAT:
PerkinElmer Inc., a global leader focused on the health and safety of people and the environment, and Sofie Biosciences, a leader in the field of PET imaging, today announced an agreement in which PerkinElmer will exclusively commercialize and sell preclinical Positron Emission Tomography (PET) – X-Ray and 3-dimensional Computed Tomography (CT) imaging systems developed by, or in conjunction with, Sofie Biosciences.

PET imaging is an essential preclinical research tool in understanding the biology of disease, biological impact of drugs, and clinical translation. PerkinElmer will work together with Sofie on the manufacturing and development of these new imaging instrument systems and assist Sofie in marketing Sofie’s chemical synthesis and advanced probe development capabilities.

These benchtop PET imaging systems provide highly sensitive and quantitative biological assays for application data in such fields as oncology, immunology, neurobiology, cardiology, and pharmacology. These systems are complementary to PerkinElmer’s current portfolio of preclinical offerings, which includes IVIS® optical imaging systems (available with integrated x-ray or CT,), high-performance dedicated Quantum™ microCT systems and a full line of imaging reagents and probes, including PET radioisotopes.

In addition to the current G4 PET/X Ray system, PerkinElmer and Sofie are announcing a new translational imaging solution, the G8 PET/CT Small Animal Imaging System. This offering integrates PET and CT into an innovative, high-performance bench top system built to enable preclinical workflows for biologists, biochemists, and pharmacologists.

“As a leading provider of imaging platforms for cellular, tissue and in vivo research, PerkinElmer is pleased to partner with Sofie, a leader in the field of PET imaging, to deliver these systems to the global preclinical research community,” said Brian Kim, President, Life Sciences & Technology, PerkinElmer. “In vivo preclinical imaging plays an integral role in translational research and drug discovery, facilitating a unique understanding of disease initiation, progression and therapeutic responses.”
“Our relationship combines PerkinElmer’s preclinical leadership with Sofie’s PET expertise to bring new translational imaging solutions to the global research community,” said Patrick Phelps, President and CEO of Sofie Biosciences.

AT SNMMI 2014:
PerkinElmer will showcase the G8 PET/CT system at Booth #1235 at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2014 conference June 7-11 in St. Louis, Missouri. Sofie will display the G8 PET/CT and G4 PET/X Ray systems, along with its chemistry product, at Booth #901.

MORE:
For more information on the G8 PET/CT or G4 PET/X-RAY systems, please visit www.perkinelmer.com/Catalog/Category/ID/PET-Imaging-Systems

About PerkinElmer, Inc.
PerkinElmer, Inc. is a global leader focused on improving the health and safety of people and the environment. The Company reported revenue of approximately $2.2 billion in 2013, has about 7,600 employees serving customers in more than 150 countries, and is a component of the S&P 500 Index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.

About Sofie Biosciences
Sofie is combining new PET imaging agents with innovative imaging and synthesis systems to provide researchers and physicians with tools to better investigate the biology of disease. By empowering a wide array of people with valuable, translational imaging tools, Sofie is making PET scans more accessible and increasing the diversity of its applications.

In Vivo Imaging Company, SOFIE Biosciences, Raises $5M Series A

CULVER CITY, CA – OCTOBER 15th, 2013 – Sofie Biosciences (SOFIE), a diagnostics company that provides molecular imaging probes and devices to help scientists and physicians investigate the biology of disease, announced today that it has raised $5M in a Series A financing.

Based on their belief in the SOFIE team, the founders, and the technology, Tata Industries through its wholly owned subsidiary, led the Series A round, with other existing investors including MRM Capital and the Cycad Group. These funds will be used to further develop technologies to reduce the cost and complexity, while increasing the availability of Positron Emission Tomography (PET) imaging and its application base. One of the most promising developments is a self-shielded microfluidic chip-based synthesizer for on-demand PET probe production.

“Closing the Series A is an important milestone for SOFIE. It will augment revenue from our growing instrument business, as well as funds brought in by grants and contracts, including $1.8M awarded this month by the NIMH. Together, these will enable the team to accelerate and expand SOFIE’s product pipeline,” said President & CEO, Patrick Phelps.

A spinout of UCLA and Caltech, SOFIE was founded in 2008 by a group of scientists, physicians, and industry professionals who have long worked toward increasing the diversity and value of PET imaging probes by removing barriers that limit access.

About Tata Industries
Tata Industries promotes the Tata group’s entry into new and high-technology businesses. It has initiated and promoted several Tata ventures in sectors like control systems, IT, auto components, advanced materials, telecom hardware and services. The Tata group, which champions deployment of technology for consumer-centric benefits, operates in seven business sectors: materials, engineering, IT and communications, energy, services, consumer products and chemicals.

About Tata Group
The Tata group comprises over 100 operating companies in seven business sectors: communications and information technology, engineering, materials, services, energy, consumer products and chemicals. The group has operations in more than 80 countries across six continents, and its companies export products and services to 85 countries. The total revenue of Tata companies, taken together, was $100.09 billion (around Rs. 475,721 crores) in 2011-12, with 58 percent of this coming from business outside India. Tata companies employ over 450,000 people worldwide. The Tata name has been respected in India for more than 140 years for its adherence to strong values and business ethics. Every Tata company or enterprise operates independently. Each of these companies has its own board of directors and shareholders, to whom it is answerable. There are 32 publicly listed Tata enterprises and they have a combined market capitalisation of about $100.54 billion (as on October 3, 2013), and a shareholder base of 3.9 million. The major Tata companies are Tata Steel, Tata Motors, Tata Consultancy Services (TCS), Tata Power, Tata Chemicals, Tata Global Beverages, Tata Teleservices, Titan, Tata Communications and Indian Hotels. For more information, visit: www.tata.com.

About Cycad Group
Cycad Group is a venture capital firm focused on investments in companies with enabling solutions, disruptive technologies and innovative products. We actively pursue investment opportunities in the life sciences, energy production, advanced materials and chemical processes. With experience investing in all phases of development, from start-up through PIPE transactions, Cycad Group seeks opportunities to work with exceptional entrepreneurs creating technology-driven businesses. For more information, visit: www.cycadvc.com.

SOFIE Bio recieves $1.8M Phase II SBIR grant

CULVER CITY, CA., October 2nd, 2013 – SOFIE BIOSCIENCES, an emerging in vivo imaging diagnostics company focused on Positron Emission Tomography (PET) probes, scanners and chemistry systems, announced today that the National Institute of Health has awarded the company a grant under the Small Business Innovation Research (SBIR) program. This Phase II award, for approximately $1.8M over three years, will be administered by the National Institute of Mental Health (NIMH) to support the development of the first digital chip technology for the rapid and easy synthesis of PET probes for neurobiology applications.

“This award is further validation of the potential for digital microfluidics to have a significant impact in research and patient care. It also comes in the wake of Illumina’s acquisition of Advanced Liquid Logic for next-generation sequencing based on the same digital fluidic handling principle known as electrowetting on dielectric (EWOD)”, said Patrick Phelps, President & CEO.

By developing a point-of-care radiosynthesizer that integrates the many unit operations for synthesis, purification, and quality control into a benchtop, affordable device, scientists and physicians in diverse fields may now have access to the vast library (3,000+) of PET probes without the normal infrastructure of prohibitively expensive equipment and specialized personnel that is currently a roadblock to using PET. The technology in this grant will provide researchers and clinicians additional tools to study the brain in normal and diseased states, and subsequently develop therapeutics to improve patient quality of life.

These funds will augment internal R&D investment, allowing the company to accelerate the commercialization of a microfluidic-based radiosynthesizer for synthesizing PET probes on-demand for brain imaging and other applications. Dr. Melissa Moore, Senior Director of Technology Development, who will be the Principal Investigator working in close collaboration with sub award investigator, Dr. R. Michael van Dam, at UCLA, commented, “We are so fortunate, especially in the current funding climate, to be awarded this Phase II from the NIMH, signaling their support to bring a revolutionary technology to market. We believe that miniaturizing all aspects of radiosynthesis, including shielding and reaction volumes, is a critical step to providing the freedom to synthesize PET probes on demand in a fully-automated, reasonably priced package.”

SOFIE Biosciences receives $1M Phase II SBIR grant from the DOE

CULVER CITY, Calif., July 11, 2012 — Sofie Biosciences, Inc., a molecular imaging company offering a comprehensive range of products from preclinical imaging systems to novel diagnostic PET imaging probes, announced today that the Department of Energy has awarded the company a grant under the Small Business Innovation Research (SBIR) program. This Phase II award, for approximately $1M, will support the development of a microscale technology for rapid, easy synthesis of PET probes.

Presently, scientists and clinicians must accept the limitations of the centralized radiopharmacy model of PET probe production and distribution, where a limited number of probes are available from radiochemistry cores or, more often, commercial radiopharmacies that provide an even smaller menu from which to choose. The end result is that the average investigator is restricted to a handful of PET probes, namely [18F]FDG, [18F]NaF, and occasionally [18F]FLT, leaving the 1,600+ probes that have been synthesized just out of reach, thus drastically limiting the translational power of PET to a few disciplines and applications.

“We are extremely pleased to be recognized with this highly competitive award from DOE,” said Patrick W. Phelps, President and CEO. “It’s an important step to further the development of a proprietary, game-changing technology that will provides researchers and clinicians with a first-generation device for the production of one-pot PET probes.”

These funds will be invested alongside Sofie resources to help broaden access to novel PET probes to answer fundamental biological questions in disease. “Winning this grant from DOE both supports and accelerates our efforts to bring radiochemistry-on-chip to market, a critical step in Sofie’s vision of creating a transformative technology of an affordable, compact, easy-to-use system for the on-demand production of PET probes,” commented Dr. Melissa Esterby, Director, Technology Development, who will be the Principal Investigator working in close collaboration with co-PI and inventor Dr. R. Michael van Dam at UCLA.

SOFIE Biosciences launches ELIXYS, a new generation of automated radiochemistry for producing PET imaging probes

CULVER CITY, CA., June 4, 2012 – Sofie Biosciences, Inc., specializing in the development of in vitro and in vivo PET imaging systems and probes, introduces ELIXYS, the newest addition to their product pipeline. Formally debuted at this week’s 2012 Society for Nuclear Medicine Annual Meeting, ELIXYS is an automated radiochemistry platform for the production of a diversity of PET probes, including [18F]FAC and analogs, SOFIE’s proprietary class of imaging probes.

Positron Emission Tomography (PET) is a medical imaging modality that utilizes radiolabeled molecules (“probes”) to target and measure biological and pharmacological processes. Basic scientists can use the same probes to visualize and characterize the biology of disease, monitor its progression, and evaluate therapeutic efficacy in cells and mice as clinicians do in patients. Over 1,600 PET probes have been developed, but only a few are routinely used. This is largely due to the complexity of synthesis, which inhibits the probe discovery and development processes in research and clinical trials. The solution to this problem requires technology innovation in radiosynthesizers, as well as breakthroughs in synthesis methods to provide rapid, site-directed labeling with high yields on a single platform capable of synthesizing a diversity of PET probes. This is also a requirement for the transition from R&D to a standardized protocol for routine production in commercial PET radiopharmacies.

ELIXYS is a novel approach to radiosynthesis. Its multi-reactor system features disposable cassettes for simplicity of operation, high-temperature and high-pressure capabilities, on-demand reagent delivery, radiation sensors and reactor vial cameras to monitor synthesis processes, between-reactor purification, an automated HPLC injection valve, and intuitive, unit operation-based software for use on tablets and smartphones, such as the iPad and iPhone. With very little effort, ELIXYS enables the end user to quickly transition between different syntheses by simply changing cassettes, reagents, and selecting software protocols.

“Fundamentally, ELIXYS is a different way to approach radiochemistry,” said Patrick Phelps, SOFIE’s President and CEO. “ELIXYS was born out of our own need to develop and synthesize diverse classes of probes. SOFIE, with our collaborators at UCLA and Caltech, are excited to share this novel technology platform with a large community of scientists and clinicians interested in expanding the diversity of PET probes to answer a vast array of biological questions.”

Learn more about ELIXYS >>>

SOFIE Biosciences receives Phase I SBIR grant from the NIH/NIMH

CULVER CITY, CA., April 24th, 2012 – Sofie Biosciences, Inc., a molecular imaging company offering a comprehensive range of products from pre-clinical imaging systems to new PET diagnostic imaging probes, announced today that the National Institute of Health has awarded the company a grant under the Small Business Innovation Research (SBIR) program. This Phase I award, for approximately $150,000, will be administered by the National Institute of Mental Health (NIMH) to support the development of a microscale technology for the rapid and easy synthesis of PET probes for neurobiology applications.

Presently, scientists and clinicians must accept the limitations of the centralized radiopharmacy model of PET probe production and distribution, where a limited number of probes are available from radiochemistry cores or, more often, commercial radiopharmacies that provide an even smaller menu from which to choose. The end result is that the average investigator is restricted to a handful of PET probes, namely [18F]FDG, [18F]NaF, and occasionally [18F]FLT, leaving the 1,600+ probes that have been synthesized just out of reach, thus drastically limiting the translational power of PET to a few disciplines and applications.

“We are extremely pleased to be recognized with this highly competitive award from NIH,” said Patrick W. Phelps, President and CEO. “It’s an important step to further accelerate the development of a proprietary, game changing PET probe synthesizer that provides researchers and clinicians with an affordable, compact, easy-to-use, disposable, chip-based radiosynthesizer for on-demand production of PET probes on the bench.”

These funds will be invested alongside SOFIE resources to help broaden access to novel PET probes to answer fundamental biological questions in disease, especially with respect to those relevant for brain imaging. “Winning this grant from NIMH both supports and accelerates our efforts to bring radiochemistry-on-chip to market, a critical step in SOFIE’s vision of creating a transformative technology that ultimately expands the use of PET imaging beyond the few probes that are commercially available,” commented Dr. Melissa Moore, Director of Technology Development, who will be the Principal Investigator working in close collaboration with co-PI Dr. R. Michael van Dam at UCLA.

SOFIE Biosciences is awarded a US patent on a family of novel PET probes for use in oncology and immunology

CULVER CITY, CA., January 11, 2012 – Sofie Biosciences, Inc., offering a comprehensive range of technologies from pre-clinical imaging systems to the development new molecular imaging probes to better understand human disease, will be granted a U.S. Patent (Number 8,101,740) from the United States Patent Office. The patent, which will issue on January 24, 2012, covers a family of novel PET probes, including 1-(2’-deoxy-2’-[18F] FluoroArabinofuranosyl)Cytosine ([18F]FAC).

Positron Emission Tomography (PET scan) is an advanced scanning technology that utilizes labeled molecules (“probes”) to target and measure biological processes. Basic scientists can use the same probes to examine cells and mice as physicians do in patients to visualize and characterize the biology of disease, monitor its progression, and evaluate therapeutic efficacy.

Researchers and clinicians at UCLA identified this novel PET probe, [18F]FAC, which was created by altering the molecular structure of gemcitabine, one of the most common chemotherapy drugs. Its action is based on the DNA salvage pathway – a fundamental biochemical pathway that helps with DNA replication and repair. For example, cancerous tumors are characterized by cell division, which is no longer controlled as it is in normal tissue. These cancer cells no longer have the normal checks and balances in place limit cell division. FAC measures this process of malignant transformation from normal to disease. By preventing DNA replication and repair, cancer drugs may shutdown the spread of disease. Ultimately, FAC could help find physicians find tumors that will respond to certain drugs (like gemcitabine), thus enabling more patient-specific treatments. Cells that initiate immune response also use this pathway and show differentiation uptake of FAC. Such a non-invasive imaging tool could help doctors more effectively model and measure the immune system over time.

“FAC is an amazing probe. It targets one enzyme and when you take that one enzyme out, the molecule is not promiscuous. Compound displays fast in vivo clearance, rapid accumulation, sufficient in vivo stability, good bioavailability, and low (or zero) immunogenicity and toxicity in humans. Making FAC available for broad use in both academic and commercial research communities will be fundamental to success.” said Patrick Phelps, Sofie’s President and CEO.

Sofie has obtained an exclusive license from The Regents of the University of California. Three investigational new drug (IND) applications have been approved for these probes and clinical trials are ongoing.

SOFIE Biosciences is awarded a DOE Phase II SBIR to commercialize microscale radiochemistry

CULVER CITY, CA., July 7th, 2011 – Sofie Biosciences, developer of molecular imaging systems and probes, has been awarded a 2011 Phase I Small Business Innovation Research grant from the Department of Energy. Of the 2,163 applications received in response to their funding notice, only 197 were selected to receive Phase I grants.

Positron Emission Tomography (PET) is a molecular imaging modality that utilizes radiolabeled molecules (“probes”) to target and measure biological processes. Basic scientists can use the same probes to examine cells and mice as they do in patients to visualize and characterize the biology of disease, monitor its progression, and evaluate therapeutic efficacy. Over 1,600 PET probes have been developed to help answer a variety of biological questions, but only the glucose analog ([18F]FDG) is routinely used. This limitation exists because of the centralized radiopharmacy approach to PET probe production, with its complexity, high infrastructure cost, and necessity of specialized equipment and skilled personnel.

A decentralized approach to PET probe development is essential to give scientists and clinicians the freedom to determine what probes they want to use to solve the problems of their interest. This goal can be achieved by building a benchtop, PC-controlled, microscale chip-based commercial device for the on-demand production of PET probes, as is the focus of the grant.

“Winning this award enables our company to further accelerate the development of a truly disruptive technology that will allow researchers and physicians to make whatever PET probe they desire, onsite, and in a cost effective fashion,” said Patrick Phelps, Sofie’s President and CEO.

Creating a point-of-research/point-of-care distribution model is a transformational solution that empowers scientists and clinicians to control the development and use of PET probes as an alternative to the well-established centralized model. Sofie’s line of molecular imaging systems, radiochemistry modules, and probes enable PET to be more widely accessible, cost-effective, and convenient for integration into a variety of labs.