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ICBII Announces the Filing of Orphan Drug Designation Application for the Use of α-Synuclein-SMART Molecule in the Treatment of Multiple System Atrophy

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La Jolla, California, USA, December 4, 2017 (PR Newswire): Innovative California Biosciences International, Inc., (“ICBII”), announced on November 20th the submission of their Orphan Drug Designation application to the US Food and Drug Administration (FDA) for the use of α-synuclein-SMART Molecule (α-Syn-SM), a novel antibody mimic, in the treatment of Multiple System Atrophy (MSA).

MSA is a rapidly progressive neurodegenerative disease with a mean survival of 6-10 years post diagnosis. This disease arises from the misfolding and accumulation of the protein α-synuclein in oligodendrocytes, where it forms glial cytoplasmic inclusions killing neurons and glial cells. Based on current census, prevalence, and National Institute of Health (NIH) data, there are estimated to be fewer than 15,000 to 50,000 MSA patients in the US. In the US and Europe, 66% to 82% of MSA patients have parkinsonian features (MSA-P). MSA-P has been designated an orphan disease.  According, ICBII has requested that the FDA grant the α-Syn-SM for MSA Orphan Drug Status.

MSA is a seriously debilitating disease for which there is no cure. It is characterized by a variable combination of Parkinsonism, cerebellar impairment, and autonomic dysfunction. It encompasses three presentations of a single disease, specifically Shy-Drager syndrome (which emphasized autonomic dysfunction), striatonigral degeneration (which emphasized parkinsonian symptoms), and sporadic olivopontocerebellar atrophy (which emphasized cerebellar symptoms).

About SMART Molecules

SMART Molecules (SMs) are novel antibody mimics that cross the blood-brain barrier (BBB) into the central nervous system (CNS) where they selectively target and inhibit the expression of pathological proteins in animals. SMART is an acronym that stands for Specific Molecular Architecture for Recognition and Therapy. The Company has developed a SMART Molecule for α-synuclein, which, when administered intravenously, allows quantitation of aberrant/misfolded α-synuclein in the brain of treated mice by a brain scan and halts its expression in a dose dependent manner.

“With this Orphan Drug Designation, hopefully the FDA will fast track the development and approval process of   α-Syn-SM in the treatment of MSA-P and related Parkinson’s disorders. It will be a major advancement in moving the SMART Molecules technology platform forward towards treating Parkinson’s, MSA, Alzheimer’s, Glioblastoma, and other central nervous system Diseases,” stated Ram Bhatt PhD, CEO/CSO of ICBII.

ABOUT ICBII The Company was founded in October of 2008 for the sole purpose of addressing unmet medical needs related to the diseases of the central nervous system.  The blood brain barrier has effectively excluded the brain from the entire biotech revolution.  With its SMs technology ICBII’s mission is to impact the lives of millions of patients worldwide by ameliorating their suffering. ICBII has currently two patents issued and seven patents pending with several more ready to be filed.

Forward Looking Statements

This press release may contain forward-looking statements, including ICBII’s development of SMART Molecules™ for altering the course of MSA and other α-synucleinopathies.  Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. ICBII expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in ICBII expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based for any reason, except as required by law, even as new information becomes available or other events occur in the future. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.

Contact Information: info@icbii.com

Investor Relations: Ken Evans, kevans@icbii.com

Third Party Validation of BBB Permeability and Target Specificity of SMs by Dr. Eliezer Masliah, UCSD

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L A JOLLA, Calif. – May 11, 2014 – On May 11, 2014, ICB International, Inc., (“ICBI”), announced confirmation of third-party validation provided by Dr. Eliezer Masliah of the University of California, San Diego. Dr. Eliezer Masliah has shown, upon being provided the necessary materials by the ICBI team, that the amyloid-beta-SM  molecule and the α-Synuclein-SM traffic the blood-brain barrier, breach the blood-brain barrier and reach their target, whereas the amyloid-beta mouse monoclonal antibody and the α-Synuclein mouse monoclonal antibody do not.

Validation of ICBI’s blood-brain barrier permeability and target specificity by Dr. E. Masliah points to the clinical potential of the alpha-synuclein Smart Molecule. The experiments conducted by both parties proves ICBI’s ability to penetrate the blood brain barrier in an alpha-synuclein transgenic moue and also shows how it is specifically bound to both Lewy body-like deposits and α-syn aggregates.

“These recent discoveries place ICBI among the

potential world leaders in efforts to develop

diagnostics and therapies for brain disorders,”

says founder, Dr. Ram Bhatt.

ABOUT THE COMPANY: ICBI is a privately-owned La Jolla, CA based biotech Company engaged in developing proprietary modular platform technology, SMART Molecules, for diagnosing and treating diseases of the central nervous system and cancers of all types. Website: www.icbii.com.

FORWARD-LOOKING STATEMENTS

This press release may contain forward-looking statements, including ICBI’s development of SMART Molecules as SPECT/PET ligands for Parkinson’s disease. Each of these statements may involve risks and uncertainties. Actual results may differ materially from those, expressed or implied.

Media Contact: Ram Bhatt, ICB International, Inc., 858-455-9880, rbhatt@icbii.com.

Michael J. Fox Foundation: 2013 Rapid Response Innovation Awards – ICBI to Receive Grant

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L A JOLLA, Calif. – April 4, 2014 – On April 4, 2014, ICB International, Inc., (“ICBI”), announced confirmation of it’s grant received from the Michael J. Fox Foundation upon being selected as one of the foundation’s list of 2013 Rapid Response Innovation Award-Winning companies.

The grant allowed ICBI to demonstrate successful study the pharmacology of α-Synuclein-SM in 72 mice at the Center of Molecular Imaging, Canada.

Founded in 2000, The Michael J. Fox Foundation for Parkinson’s Research (MJFF) is the world’s largest nonprofit funder of Parkinson’s disease (PD) research and a
thought-leader in the field.

The Michael J. Fox Foundation has made significant investments in research to understand alpha-synuclein and to translate it into therapeutic strategies for advancing a cure for Parkinson’s disease.

The alpha-synuclein protein is a major component of Lewy bodies, clumps of aggregated protein that are a cardinal neuropathological feature of Parkinson’s disease.
Mutations in the alpha-synuclein gene were some of the first linked to Parkinson’s disease and provide further evidence for its causal role in the disease. These strong
pathological and genetic links make alpha-synuclein a key target for therapeutic development.

The blood brain barrier represents a formidable challenge for successful delivery of macromolecules such as antibodies to the central nervous system. In an effort to achieve greater blood brain barrier penetration than obtained with conventional
antibodies, ICBI, Inc. has developed a novel class of alpha-synuclein “picobodies” of ~50kDa, which are designed to serve as a positron emission tomography (PET) ligands for the detection and monitoring of PD in vivo.

The aim of this study is to determine the pharmacokinetics and biodistribution of these picobodies, as well as their efficiency in reaching the brain and binding to alpha-synuclein aggregates. Successful development of this technology could enable early detection of Parkinson’s disease in at-risk individuals and facilitate monitoring of disease progression in PD patients.

Upon receiving the grant, ICBI was able to establish a collaboration with CIMS (Centre D’imagerie Moleculaire de Shebrooke, QC, Canada). ICBI scientists have provided the skills and technology required for the generation of the necessary picobody for alpha-synuclein (a-syn-pico). CIMS collaborators provided radiochemistry for labeling of a-syn-pico, followed by determination of biodistribution and pharmacokinetic studies of a-syn-pico.

The administration of a 125I-α-synuclein-SM via the tail vein to a Transgenic and non-transgenic mice showed first pictures of α-Syn ever seen in a live animal. The non transgenic mice is along the top row of all panel. The transgenic mice over expressing α-Syn outline the bottom row of all panels. As one scans from 1 hour to 72 hours a signal becomes perceptible with the transgenic mouse at the bottom of each picture showing a higher concentration of the α-Syn Smart Molecule, proving successful trafficking of the Blood Brain Barrier.

“These recent discoveries place ICBI among the

potential world leaders in efforts to develop

diagnostics and therapies for brain disorders,”

says founder, Dr. Ram Bhatt.

ABOUT THE COMPANY: ICBI is a privately-owned La Jolla, CA based biotech Company engaged in developing proprietary modular platform technology, SMART Molecules, for diagnosing and treating diseases of the central nervous system and cancers of all types. Website: www.icbii.com.

FORWARD-LOOKING STATEMENTS

This press release may contain forward-looking statements, including ICBI’s development of SMART Molecules as SPECT/PET ligands for Parkinson’s disease. Each of these statements may involve risks and uncertainties. Actual results may differ materially from those, expressed or implied.

Media Contact: Ram Bhatt, ICB International, Inc., 858-455-9880, rbhatt@icbii.com.

Brain Imaging Tracer for Parkinson’s Disease

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L A JOLLA, Calif. – April 11, 2014 – On On March 4, 2014, ICB International, Inc., (“ICBI”), announced the development of a tracer for imaging alpha-synuclein (a-Syn) in Parkinson’s-like mice at the Keystone Symposium for Parkinson disease (PD) in Keystone,Colorado. Speaking at the symposium, Dr. Anna Cartier, a key advisor at ICBI, presented scientific data and showed images for the first successful live visualization of a-Syn in the brains of mice with and without PD using ICBI’s proprietary SMART Molecule Technology. ICBI has created an a-Syn-SMART Molecule (a-Syn-SM) that enters the blood stream, passes through the blood-brain barrier (BBB) into the central nervous system (CNS) and latches onto its target, a-Syn.

A-Syn is an important pharmaceutical target for PD. The aggregation and accumulation of misfolded a-Syn constitutes the hallmark of a group of neurodegenerative diseases, referred to as synuceinopathies, including Parkinson’s disease. Recently, scientists at the Michael J.Fox Foundation (MJFF) published an article in the Journal of Parkinson’s disease that “the ability to image a-Syn deposition in the brain would be a game changing achievement for the Parkinson’s field”. ICBI has addressed this challenge in an animal model.

In the study, a live transgenic (Tg) mouse with PD and a normal control were injected with iodine-125 labeled a-Syn-SM in the tail vein. Single Photon Emission Computing Tomography (SPECT) was used to visualize a-Syn with the radio-labeled a-Syn-SM in these mice. A-Syn was detected in the brain by radio-labeled SM as early as one hour post injection with continued accumulation of radio-labeled SM in the brain for 8 days. These findings, which are consistent with prior results using multiple Tg mice injected with unlabeled a-Syn-SM, strongly support the clinical utility of a-Syn-SM as a SPECT/PET imaging tool for Parkinson’s disease.

Delivery of disease modifying drugs to the CNS has been a problem since the origin of mankind. A physical barrier, the BBB, regulates what goes to the brain. Small molecule drugs that can reach the CNS may provide short-term symptomtic relief but often do nothing to modify the disease. Large molecules that can potentially modify the disease have poor access to the CNS. ICBI is determined to change that with its SMART Molecule technology.

“These recent discoveries bring ICBI closer to

developing diagnostics and disease modifying

therapeutics for neurodegenerative disorders,”

says founder, Dr. Ram Bhatt, Ph.D.

Dr. Ram Bhatt, Ph.D further states that although these preliminary results are very exciting, there is still a considerable amount of work to be done before this technology will be cleared by the US FDA for use in patients for the early diagnosis and monitoring of disease (synucleinopahies) progression or regression during therapy.

ABOUT THE COMPANY: ICBI is a privately-owned La Jolla, CA based biotech Company engaged in developing proprietary modular platform technology, SMART Molecules, for diagnosing and treating diseases of the central nervous system and cancers of all types. Website: www.icbii.com.

FORWARD-LOOKING STATEMENTS

This press release may contain forward-looking statements, including ICBI’s development of SMART Molecules as SPECT/PET ligands for Parkinson’s disease. Each of these statements may involve risks and uncertainties. Actual results may differ materially from those, expressed or implied.

Media Contact: Ram Bhatt, ICB International, Inc., 858-455-9880, rbhatt@icbii.com.