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    Testing For Alzheimer’s Disease Long Before Symptoms Appear

    January 1, 2019 — Alzeca’s story is on National Public Radio. On this podcast of Tech Nation Health, host Moria Gunn interviews CARLO MEDICI, CEO of Alzeca, and describes the company’s approach to testing for Alzheimer’s Disease, long before any outward symptoms appear.

    Better Biomarkers for AD R&D

    September 13, 2018 — Alzheimer’s disease has been a minefield for recent drug development, marked by a series of clinical trials whose failures suggest that therapeutic interventions will need to be directed earlier in the disease process. The Pathologist features a new article, authored by Alzeca’s CEO Carlo Medici, on the impact that precision medicine will have on the future of Alzheimer’s disease diagnostics.

    PM360 Presents the 2017 Innovators

    HOUSTON, TX, December 26, 2017 — Each December, PM360 Magazine chooses the companies, divisions, startups, products, services and strategies that they believe are at pharma’s leading edge. Alzeca was honored to be one of the 14 startups named this year as 2017’s most innovative companies (https://www.pm360online.com/pm360-presents-the-2017-innovators/)

    Alzeca Biosciences Closes $11 Million Series A Financing

    Funds will advance development of first targeted imaging agent on conventional MRI to detect beta-amyloid plaques of early Alzheimer’s disease

    HOUSTON, TX, August 17, 2017 — Alzeca Biosciences, Inc., an early-stage healthcare diagnostic company focused on developing novel MRI-based targeted imaging agents for the early diagnosis of Alzheimer’s disease and other neurodegenerative disorders, announced today that it has closed an $11 million Series A financing.

    With the transaction, Peter J. Werth, Jr., President and Chief Executive Officer of Chemwerth, Inc., and Navneet Puri, Ph.D., Founder and Chief Executive Officer of Nevakar, LLC, joined the Alzeca Board of Directors.

    Alzeca will use the funds to advance the development of its ADx nanoparticle, the first magnetic resonance imaging (MRI) contrast agent targeting amyloid plaques, through Phase 1 human clinical trials. Amyloid is one of the key brain proteins associated with Alzheimer’s disease and other neurodegenerative conditions. Additionally, the new funding will enable Alzeca to accelerate development of MRI-based imaging agents targeting other abnormal brain proteins associated with Alzheimer’s disease and other causes of dementia, including chronic traumatic encephalopathy (CTE).

    “We are very pleased to complete this significant round of financing with experienced private investors who have a firm commitment to advancing these urgently needed healthcare innovations in Alzheimer’s disease and other types of dementia,” said Carlo Medici, CEO of Alzeca.

    Until now, the accuracy of diagnosis in Alzheimer’s disease has been very low. Recent research has suggested that PET (positron-emission tomography) brain imaging of amyloid plaque deposition could improve dementia diagnosis in up to two-thirds of patients. However, PET imaging is costly, not widely available to healthcare providers, and subjects patients to high doses of radiation (equivalent to up to 70 chest x-rays). By comparison, the successful development of ADx would make early and reliable Alzheimer’s diagnostic testing available worldwide, using MRI scanning technology that is broadly accessible, at far lower cost and without any radiation exposure. Detection of Alzheimer’s disease a decade or more before symptoms appear would revolutionize its treatment and vastly improve the efficiency of clinical trials for new therapies by identifying appropriate candidates for participation and monitoring their response to new drugs.

    “The ability to diagnose neurodegenerative diseases such as Alzheimer’s years before serious cognitive impairment manifests, so as to potentially intervene therapeutically at an early stage in the disease process, is a significant healthcare challenge,” said Mr. Werth. “We are excited to partner with Alzeca because its promising MRI brain imaging agents offer great potential not only to advance the early diagnosis of such conditions but also to aid in monitoring patient response to treatment both during drug development and in the clinic.”

    “Alzeca is addressing a critical healthcare need and has assembled a highly experienced management team composed of world-renowned experts in diagnostic imaging, clinical neurosciences and commercial pharmaceutical and biomedical development,” said Dr. Puri. “Bringing novel diagnostic approaches and more accurate biomarkers to address the challenges of Alzheimer’s disease and other neurodegenerative diseases is a worthy cause and will benefit millions of patients, caregivers and healthcare providers. I am very happy to support them and invest in this endeavor.”

    Biographies of the New Alzeca Board Members

    Peter J. Werth, Jr. founded Chemwerth, Inc., in 1982 and serves as its Chief Executive Officer and President. A pioneer in developing and supplying generic active pharmaceutical ingredients, Mr. Werth has committed his professional life to improving global access to high-quality, affordable generic pharmaceuticals.  Mr. Werth is also a recognized philanthropist, establishing the Werth Family Foundation in 2001 to support higher education, children and human services, the arts and the environment.

    Navneet Puri, PhD, is Founder and Chief Executive Officer of Nevakar, LLC. After earning his MS and PhD in Pharmaceutics, Dr. Puri worked for several years at Baxter Healthcare Corp and Amgen Inc. in the areas of parenteral drug development and drug delivery. Dr. Puri founded InnoPharma, Inc., in 2005 with a focus on developing complex generic pharmaceuticals of sterile injectable dosage forms. The company was acquired by Pfizer in 2014. Dr. Puri received the Smart CEO award from Future 50 magazine in January 2015. He was also awarded an E&Y Entrepreneur of the Year award from the state of New Jersey in June 2015.

    About Alzeca Biosciences, Inc.

    Alzeca Biosciences is an early-stage company focused on developing novel, proprietary, targeted MRI imaging agents for the early diagnosis of Alzheimer’s disease and other neurodegenerative disorders. The company’s proprietary technology is based on nanoparticles that specifically bind to abnormal proteins that accumulate in the brain years before significant cognitive symptoms appear. Alzeca’s imaging agents would provide a new opportunity for safe, cost-effective, and widely available diagnosis and screening for these important diseases. Alzeca Biosciences is based in Houston. For more information on the company, please visit our website at https://alzeca.com.

    Press Release (pdf)

    CONTACT

    Alzeca Biosciences, Inc.
    Carlo Medici, CEO
    1-609-933-1258, carlo@alzeca.com

    For Media
    Joan Kureczka, Bioscribe
    Joan@bioscribe.com
    1-415-821-2413

    Alzeca Biosciences’ ADx Imaging Technology Shows Positive Results in Early Detection of Alzheimer’s

    • ADx Could Identify Disease a Decade Before Symptom Onset
    • Technology crosses the blood brain barrier
    • Pivotal results in neurodegenerative disease research

    June 07, 2016 10:00 AM Eastern Daylight Time

    HOUSTON–(BUSINESS WIRE)–Alzeca Biosciences announced successful preliminary preclinical results for ADx, its innovative, proprietary diagnostic imaging technology, designed to enable diagnosis of Alzheimer’s disease a decade or more before the onset of symptoms of cognitive decline.

    “Alzeca has brought together incredible breakthrough science and a highly experienced leadership team to accelerate the company’s strategy and address a huge unmet need for physicians and patients alike in neurodegenerative disease”

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    Successful development of ADx would make early and reliable Alzheimer’s testing broadly available, using magnetic resonance (MR) technology, at far lower cost and without the radiation of current positron emission (PET) scans. Earlier detection of Alzheimer’s could revolutionize the treatment of the disease and vastly improve the efficiency of clinical trials for new therapies by identifying appropriate candidates.

    “Alzeca is building a pipeline with a multi-modality and multi-disease approach using our proprietary technology platform ADx,” said Carlo Medici, Chief Executive Officer, Alzeca Biosciences. “Following these positive results, we will aggressively bring this unique technology to the next phases of development and pursue partnerships that will enable us accelerate the company’s strategy.”

    Alzeca is also exploring the significant additional potential of the underlying platform of ADx, which can be modified to bind to different targets in the brain. With these modifications, the platform could be used to image and diagnose other serious neurodegenerative diseases, and even be used as a drug delivery system for those diseases.

    Related information: https://alzeca.com/

    Initial Tests Yield Strong Preclinical Results

    In peer-reviewed studies, ADx nanoparticles demonstrated the ability to carry an encapsulated imaging agent across the blood-brain barrier and bind precisely to amyloid plaques in the brains of test mice. Researchers were then able to obtain precise, high-resolution images of those plaques using ordinary MR equipment. These results, along with successful preliminary toxicity studies, have prompted Alzeca to accelerate the development and testing of ADx with the goal of beginning human clinical trials in 2018.Related information: http://content.iospress.com/articles/journal-of-alzheimers-disease/jad151124

    Significant Unmet Need

    More than 27 million people suffer from Alzheimer’s disease today globally, and it is the sixth leading cause of death in the US. By 2050, the disease could result in a $1.1 trillion annual cost to the US healthcare system, in current dollars, not including the very high cost of unpaid care. Yet there is no cost-effective, readily available, reliable way to diagnose the disease before the onset of cognitive decline – which is when current Alzheimer’s therapies are most likely to be effective.

    ADx has the potential to confirm an Alzheimer’s diagnosis, as well as to rule out such a diagnosis. Misdiagnosed dementia patients not only receive the wrong therapies, but the cost of treating a misdiagnosed patient adds as much as $14,000 to the annual cost of treatment.

    Related information: http://www.alz.org/facts/overview.asp

    Powerful Technology

    Alzeca’s innovative biodiagnostic platform is a nanoparticle that can encapsulate an imaging marker or other “payload” and pass through the normally impenetrable blood-brain barrier. The outside of each nanoparticle is designed to bind precisely to specific target substances in the brain, delivering the payload to that target.

    ADx is the first product based on the platform. ADx carries an MR imaging agent as its payload and targets the amyloid plaques that are the hallmark of the onset of Alzheimer’s disease, developing ten or more years before cognitive impairment. Once ADx is bound to the plaques, they can be imaged in high resolution using a standard MRI scan. Related information: https://alzeca.com/technology

    Superior Modalities

    MR scans are far less costly and far more readily available throughout the world than the only current alternative, a PET scan. PET scans also require the use of radioactive imaging agents that preclude routine use, while ADx would permit physicians to track the patient’s condition.

    Building Strong, Experienced Leadership and Scientific Expertise

    Based on the progress, Alzeca has assembled a world class team of senior executives, including:

    • Scott W. Atlas, M.D., Chairman of the Board (former Chief of Neuroradiology at Stanford University Medical Center)
    • Carlo Medici, Chief Executive Officer (former CEO of Bracco Diagnostics, a global leader in imaging agents)
    • Thomas Hale, Chief Operating Officer (20 years with Abbott Laboratories and 10 years of additional experience in drug development)


    “Alzeca has brought together incredible breakthrough science and a highly experienced leadership team to accelerate the company’s strategy and address a huge unmet need for physicians and patients alike in neurodegenerative disease,” said Scott W. Atlas, M.D., Chairman. “We must greatly improve the standard of care as 98 percent of new treatments fail to be FDA-approved. Earlier detection of Alzheimer’s disease can help patients and their families make better life decisions.”

    Direct link to leadership team page: https://alzeca.com/leadershipteam

    Alzeca Biosciences was founded on technology invented at the University of Texas-Houston, and is based in Houston. The company was formed specifically to develop the immense potential of ADx and its underlying technology platform. Alzeca’s leadership team includes world-renowned experts in diagnostic imaging innovation, clinical neuroscience, and commercial biotech development.

    Press Release (pdf)

    Contacts

    Amicus Communications & Brand Management

    Mariesa Kemble, 1-608-850-4745,  kemblem@mac.com
    Rory O’Connor, 1-415-385-4266,  rjoconnor@amicuscbm.com