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Research Projects – United States

September 29, 2016 by Team Sanfilippo

May 2016 – A prospective one-year natural history study of mucopolysaccharidosis
types IIIA and IIIB: Implications for clinical trial design ~

Here is the abstract of the study. Several of us parent foundations funded this study for the gene therapy so we could have a natural history to share with possible trial start ups that we chose to do. In the past each drug company was doing their own Natural History Study and not willing to share the information. Rarely were any the children going thru these studies chosen for a treatment. Now we own rights to the study to use at anytime.  If you wish to view the full article you can contact one of us via email and we will gladly send you the pdf.

http://www.mgmjournal.com/article/S1096-7192(16)30184-6/fulltext

 

 

 

______________________________________________________________________________

 

 

 

 

11471 Euclid Ave, Ste 211
Cleveland OH 44106

 

Abeona Therapeutics, Inc. is developing gene therapy based potential cures for the deadly childhood diseases Sanfilippo (SF) Syndrome Type A and Type B.  In SF disease, the predominant symptoms occur due to improper cell function within the central nervous system (CNS), which result in cognitive decline, motor dysfunction, and eventual death. Our two lead products, ABX-A and ABX-B, uniquely deliver the therapeutic product to the CNS with the aim of reversing the effects of the genetic errors that cause the disease. ABX-A and ABX-B induce cells in the CNS and digestive tract to produce the missing enzymes and help repair damage caused to the cells.

Safety studies conducted in large animal models have demonstrated that delivery of ABX-A and ABX-B are well tolerated with minimal side effects. Importantly, efficacy studies in animals with Sanfilippo syndrome have demonstrated unprecedented therapeutic benefit months after treatment. A single dose of ABX-A or ABX-B significantly restored normal cell and organ function and increased the lifespan of animals with SF over 100% a year after treatment compared to untreated control animals. Similarly, animals treated with ABX-A and ABX-B demonstrated significant corrections of cognitive defects that remained months after drug administration. These results are consistent with studies from several laboratories suggesting ABX-A and ABX-B treatment could potentially benefit patients with for Sanfilippo Syndrome Type A and B, respectively.

Abeona, in partnership with Nationwide Children’s Hospital (Columbus, OH), has met with the FDA and is planning to initiate clinical studies of ABX-A and ABX-B in patients with Sanfilippo Syndrome Type A and B set to begin in 2014.

 

 

Substrate Optimization Therapy Sanfilippo A,B,C and MPSI and II
Zacharon Pharmaceuticals
Dr. Brett Crawford
Dr. Lluïsa Vilageliu lvilageliu@ub.edu

Gene Therapy Type A
University of Barcelona
Robin M Jackman RMJackman@zacharon.com

Zacharon is developing a novel small molecule therapy which selectively modulates the biosynthesis of the GAGs which accumulate in patients with MPS I, II, and III A,B and C. Due to this selective modification, the deficient enzyme is no longer required for GAG degradation thus reducing lysosomal accumulation. Zacharon has completed important preclinical development activities including the demonstration of proof of concept using MPS animal models including reduction in GAG accumulation in the brain. In March of 2011, Zacharon formed a partnership with Pfizer Inc.’s Orphan and Genetic Disease Unit to complete preclinical development and successfully advance this program through clinical trials and subsequent commercialization. The successful completion of these activities is designed to enable the first small molecule therapy capable of addressing neurological decline and other needs of patients with MPS I, II, and III A,B and C.

Lysosomal Enhancement Therapy Sanfilippo A,B,C,D and many lysosomal diseases
Texas Children’s Hospital
Marco Sardiello sardiell@bcm.edu

This project is based on our recent discovery of a gene network that controls cellular clearance by regulating lysosomal biogenesis and function (Sardiello et al. Science 2009). Lysosomes are ubiquitous intracellular organelles dedicated to the degradation and recycling of the byproducts of cellular metabolism. We have discovered that human cells have a genetic program that controls the activity of lysosomes through the modulation of master gene TFEB, which encodes a transcription factor that directly binds to promoters of lysosomal genes and coordinately activates their transcription. By acting on TFEB, we can induce the cell to make more lysosomes, hence increasing its degradation capacity.

Sanfilippo syndrome and other neurodegenerative diseases are caused by the intracellular accumulation of undegraded, toxic molecules. We postulate that the increase of cellular degradation capacity as a result of the activation of lysosomal master gene TFEB will result in the clearing of toxic molecules. Preliminary data obtained in cells from other neurodegenerative diseases (Batten disease, Huntington’s disease) showed that the enhancement of lysosomal function via TFEB over expression results in the efficient clearance of the toxic molecules that accumulate in these diseases (lipofuscins and mutated huntingtin, respectively). Moreover, cell lines stably over expressing TFEB showed enhanced ability to degrade glycosaminoglycans (Sardiello et al. 2009), the substrate that accumulates in Sanfilippo syndrome. Therefore, this clearing effect appears to be independent from the biochemical nature of accumulated substances and from the specific site of their accumulation (lysosome for glycosaminoglycans and lipofuscins, cytoplasmic for expanded hungtintin protein). This is likely due to the fact that the lysosome is implicated in autophagy, which clears portions of the cytoplasm, and TFEB is also able to promote autophagy by activating the transcription of several autophagy genes.

Dr. Sardiello discovered an already FDA approved molecule that is shown to activate TFEB. Currently this molecule is being tested on Batten mice. A colony of Sanfilippo mice are being prepared for testing this compound. Mouse study will take approximately six months to complete.

Dr. Sardiello will be screening all FDA compounds with high throughput drug screening to find compounds that can reduce toxic accumulations in Sanfilippo Syndrome.

Gene Therapy Sanfilippo B
Nationwide Children’s Hospital, Columbus, Ohio
Dr. Haiyan Fu

Dr. Fu has developed an efficient gene therapy procedure to treat MPSIIIB. We have made an AAV9 vector that has the ability to cross the blood-brain-barrier. This AAV9 vector carries the gene for NAGLU, the enzyme missing in MPSIIIB patients. By a singly intravenous injection of this AAV9-NAGLU vector, we were able to restore the NAGLU enzyme activity and correct the lysosomal storage pathology throughout the brain, spinal cord and multiple somatic tissues in adult MPSIIIB mice. Most importantly, the AAV9-vector-treated mice showed significant behavioral improvement and survived to a normal lifespan. In addition, this approach is minimally invasive and the IV injection itself has minimal risk to patients. With the generous support from the Sanfilippo families and friends through Ben’s Dream – The Sanfilippo Research Foundation, the experiments of this project are still ongoing.

We believe that we are in a very good position to move our AAV9-gene-therapy approach to clinical trial. We have established a strong team with the goal of obtaining the approval from the FDA for a Phase I/II clinical trial in patients with MPS IIIB. Led by Dr. Kevin Flanigan, MD and professor of neurology, we have submitted a Pre-pre-IND package to the FDA and have a pre-pre-IND meeting scheduled with the FDA. This Pre-pre-IND interaction is for us to get advices from the FDA on specific requirements for the Pre-IND toxicology/safety testing of our approach in animals. This Pre-IND toxicology testing is absolutely required for obtaining the FDA approval for our planned MPS IIIB gene therapy clinical trial.

Additional plans and efforts have been made to prepare for moving this MPS IIIB gene therapy to a clinical trial. 1) We have submitted a translational grant application to the NIH. 2) We are planning to establish a MPS III patient registry. 3) Establish and validate the stable high yield vector producing cell line. 4) Produce clinical grade AAV9 vectors needed for the planned clinical trial, and this is required by the FDA when submitting the IND (Investigational New Drug) application. 5). Testing our AAV9-NAGLU vector in large animals considering the clinical relevance to humans.

A recent Team Sanfilippo – Pepsi grant will add support to our work involved in establishing a high yield AAV9-hNAGLU vector production system.

Gene Therapy Sanfilippo A
University of North Carolina
Dr. Doug McCarty

Because all four forms of MPS III share similar disease properties, we believe that the gene therapy approach similar to that we developed for MPS IIIB may also be feasible for other forms of MPS involving a secreted enzyme. We have therefore expanded our gene therapy program to develop efficient AAV9 vector for the treatment of MPS IIIA. This project is led by Dr. Doug McCarty and has been supported by a research grant from the Sanfilippo Children’s Research Foundation (Canada) and Team Sanfilippo Foundation.

To date, we have made multiple AAV vectors carrying the gene for human SGSH, the enzyme missing in patients with MPS IIIA. We tested these vectors in human MPS IIIA cell cultures. The preliminary data showed that these AAV-SGSH-treated MPS IIIA cells produced and secreted SGSH enzyme. In addition, we treated the MPS IIIB cells with the secreted SGSH and saw significant reduction of GAG in these cells.

We are also in the process to establish the MPS IIIA mouse colony (with the help from Dr. Steve Walkley). The MPS IIIB mice will be used to test the AAV9-SGSH vectors and select the optimal vector for potential future clinical application in MPS IIIA patients. The goal of this project is to develop a systemic AAV9-SGSH gene therapy approach for the treatment of MPS IIIA in patients.

The very recent Team Sanfilippo – Pepsi grant will support us to construct/test the AAV9-SGSH vectors, to develop high yield AAV9-SGSH vector producing plasmid, and to initiate the development of vector producing cell line inconsideration of potential clinical application.

ERT Sanfilippo B
Synageva

Synageva research laboratory in Lexington, MA, has protein engineering capabilities and expertise in the rapid production of recombinant proteins for biological characterization. These capabilities allow us to engineer and manufacture proteins that are either identical to the defective protein or incorporate unique modifications to enhance the biological activity and/or therapeutic usefulness of the defective protein
Program SB-103 rhNAGLU

http://www.synageva.com/programs-pipeline.htm

September 19, 2013 by PattyT

 

 

 

 

11471 Euclid Ave, Ste 211
Cleveland OH 44106

 

Abeona Therapeutics, Inc. is developing gene therapy based potential cures for the deadly childhood diseases Sanfilippo (SF) Syndrome Type A and Type B.  In SF disease, the predominant symptoms occur due to improper cell function within the central nervous system (CNS), which result in cognitive decline, motor dysfunction, and eventual death. Our two lead products, ABX-A and ABX-B, uniquely deliver the therapeutic product to the CNS with the aim of reversing the effects of the genetic errors that cause the disease. ABX-A and ABX-B induce cells in the CNS and digestive tract to produce the missing enzymes and help repair damage caused to the cells.

        Safety studies conducted in large animal models have demonstrated that delivery of ABX-A and ABX-B are well tolerated with minimal side effects. Importantly, efficacy studies in animals with Sanfilippo syndrome have demonstrated unprecedented therapeutic benefit months after treatment. A single dose of ABX-A or ABX-B significantly restored normal cell and organ function and increased the lifespan of animals with SF over 100% a year after treatment compared to untreated control animals. Similarly, animals treated with ABX-A and ABX-B demonstrated significant corrections of cognitive defects that remained months after drug administration. These results are consistent with studies from several laboratories suggesting ABX-A and ABX-B treatment could potentially benefit patients with for Sanfilippo Syndrome Type A and B, respectively.

        Abeona, in partnership with Nationwide Children’s Hospital (Columbus, OH), has met with the FDA and is planning to initiate clinical studies of ABX-A and ABX-B in patients with Sanfilippo Syndrome Type A and B set to begin in 2014.

 

 

 

 

 

 

LYSOGENE ANNOUNCES COMPLETE ENROLLMENT IN ITS SAF-301 PHASE I/II CLINICAL TRIAL OF INTRACEREBRAL GENE

 THERAPY IN CHILDREN WITH SSANFILIPPO TYPE A SYNDROME.

 Paris, France – June 14, 2012 – LYSOGENE announced today that the last planned patient in its phase

I/II clinical trial in Sanfilippo Type A Syndrome (NCT01474343) had been treated with SAF-301, its

investigational intracerebral gene therapy product.

SAF-301 aims at treating this pediatric life threatening disease with a high unmet medical need and

currently no cure.

This open-label, single arm, monocentric, phase I/II SAF-301 clinical study is primarily designed to

evaluate the tolerance and the safety of the intracerebral administration of SAF-301 performed in a

single neurosurgical session. It is also designed to evaluate exploratory efficacy neuropsychological,

radiological and biological endpoints from the perspective of future pivotal studies.

“Completing full enrollment and treatment in this phase I/II study is a crucial milestone in the

development of a safe and efficacious gene therapy as what is intended to become the first line

treatment for Sanfilippo Type A disease. It also sustains the extraordinary potential of gene deliverybased

approaches for numerous other monogenic diseases with central nervous system involvement.

Our hope is to bring significant clinical benefits and quality of live improvements to numerous

patients and their families affected with such diseases worldwide”, Karen Aiach, Founder and CEO of

LYSOGENE said.

 About Sanfilippo Syndrome and LSDs

Sanfilippo Syndrome or Mucopolysaccharidosis III (MPS-III) is a group of four rare autosomal

recessive lysosomal storage diseases of which Type A accounts for approximately two thirds.

Sanfilippo Syndrome is characterized with a heavy central nervous system involvement and an

extremely severe phenotype, associated with a life expectancy reduced to the midst of the second

decade.

Sanfilippo Type IIIA Syndrome is seen in approximately 1 in 100,000 live births and affects a few

thousands patients worldwide.

MPS-III belongs to lysosomal storage diseases (LSDs), a group of over 50 inherited disorders, with a

total combined incidence greater than 1 per 8,000 births, of which 70% have a central nervous

system component.

 About LYSOGENE

LYSOGENE is a platform biotechnology company specialized in the development of intra-cerebral

gene therapy for the treatment of lysosomal diseases affecting the central nervous system, the main

cause of mortality in childhood neurodegenerative diseases.

LYSOGENE brought its first product SAF-301 from bench to the bedside in less than five years.

 

Contact

LYSOGENE – 52, rue la Boétie – 75008 Paris – France – www.lysogene.com

Mail: contact@lysogene.com

https://teamsanfilippo.org/research/741

Research Projects – United Kingdom

February 15, 2012 by Team Sanfilippo

Intrathecal Enzyme Replacement Therapy Sanfilippo A

Shire Human Genetics
Dr. Simon Jones
Dr. Frits Wijberg

A Phase I/II Safety, Tolerability, Ascending Dose and Dose Frequency Study of Recombinant Human Heparan N-Sulfatase (rhHNS) Intrathecal Administration Via an Intrathecal Drug Delivery Device in Patients With Sanfilippo Syndrome Type A (MPS IIIA)

Shire Human Genetic Therapies (Shire HGT) is developing a sulfamidase enzyme replacement therapy (ERT)rhHNS for patients with MPS IIIA. rhHNS is being administered into the cerebrospinal fluid (CSF) via a surgically implanted intrathecal drug delivery device (IDDD).

This study is a multicenter, multiple-dose, dose escalation study designed to evaluate the safety, tolerability, and clinical activity of up to 3 dose levels (2 doses [10 and 45mg] monthly and 1 dose [45mg] every other week for 6 months) of rhHNS administered via an IDDD in patients with Sanfilippo syndrome Type A ages greater than or equal to 3 years of age.

The phase I/II clinical trial is planning to enroll 15 patients, beginning June 2010. The study is expected to be completed March 2012, and the duration of the study for each patient is nine months.

The Phase I / II clinical study is being conducted at two sites:

  • Emma Children’s Hospital, Academic Medical Center in The Netherlands by Dr. Frits Wijberg
  • St. Mary’s Hospital in Manchester, UK under the direction of Drs. Simon Jones and Ed Wraith.

Additional information about the clinical trial can be obtained at www.clinicaltrials.gov (Identifier: NCT01155778) or by contacting Tiffany Crump 484-595-8257, tcrump@shire.com This e-mail address is being protected from spambots. You need JavaScript enabled to view it or Daryll Heron +44 1256 894572, dheron@shire.com.

Research Projects – Spain

February 15, 2012 by Team Sanfilippo

Sanfilippo C: TBA
University of Barcelona. Department of Genetic
Dr. Daniel Grinberg dgrinberg@ub.edu
Dr. Lluïsa Vilageliu lvilageliu@ub.edu

Gene Therapy Type A
University of Barcelona
Dr. Fatima Bosch fatima.bosch@uab.es

This week in the meeting of The Committee for Orphan Medicinal Products (COMP), has been presented to the European Medicines Agency (EMEA) the drug “Adeno-associated virus vector serotype 9 expressing human sulfamidase for treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome), D. Esteve Labs, S.A. – EMA/OD/171/10)

Research Projects – Poland

February 15, 2012 by Team Sanfilippo

Substrate Reduction Therapy Sanfilippo A,B,C,D (Genistein Derivatives)
University of Gdansk Department of Molecular Biology
Dr. Grzegorz Wegrzyn wegrzyn@biotech.ug.gda.pl

Dr. Wegrzyn has tested many synthetic, artificial derivatives of genistein. Based on his evaluation there are a few that are promising (ability to inhibit GAG synthesis, low cytotoxicity and high potential to cross the blood-brain-barrier). Until now, we have performed only experiments on cell cultures, thus, the next step should be tests on mice. The promissing molecules are about 50% more active than genistein, are 2-3 times less toxic than genistein (though genistein is still fine in these tests), and have several times higher LogP index (calculated theoretically on the basis of chemical formulas) suggesting their more efficient crossing the blood brain barrier. We are now negotiating with a company which is interested in patenting these molecules.

Research Projects – Italy

February 15, 2012 by Team Sanfilippo

Substrate Reduction Therapy Sanfilippo A,B,C,D
Medical School, University of Naples Federico II
Dr. Giancarlo Parenti parenti@unina.it
Dr. Paola Di Natale dinatale@dbbm.unina.it

Development of inhibitor of GAG synthesis. Dr. Parenti and Dr. Natale have developed a compound that is an efficient inhibitor of GAG synthesis, thus reducing the amount of heparin sulfate the body produces.

Research Projects – France and Netherlands

February 15, 2012 by Team Sanfilippo

Gene Therapy Sanfilippo B
AMT & Institut Pasteur
Jean-Michel Heard jmheard@pasteur.fr

Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in human gene therapy, announced that it has entered into an agreement with Institut Pasteur, Paris, France, and a group of French research institutes (together the “Consortium”) to support clinical development of a novel gene therapy to treat Sanfilippo B.

On behalf of the Consortium, Institut Pasteur will lead the development program and will also sponsor the initial Phase I/II clinical study of a gene therapy to replace an enzyme (alpha-N-acetylglucosaminidase) that is missing in brain cells of Sanfilippo B patients. This enzyme is specifically required for the degradation of heparan sulfate glycosaminoglycans (GAGs), essential carbohydrate molecules used to build tissue. The accumulation of incompletely degraded GAG molecules triggers a cascade of pathological events leading to neuronal dysfunction and death.

AMT will manufacture and supply the adeno-associated viral 5 (AAV5) gene therapy product to the Consortium. Thanks to donations collected during the French Telethon, the French Muscular Dystrophy Association (AFM), a Consortium member, will fully fund the development program through to completion of the Phase I/II clinical study, including all AMT manufacturing costs. The overall manufacturing contract entails payments to AMT of EUR1.8 million. If the Consortium successfully demonstrates proof of concept in the Phase I/II study, AMT will have an option to acquire full commercial rights for the program.

 

 

Gene Therapy Sanfilippo A

LYSOGENE

Locations:

Hôpital Bicêtre – Assistance Publique des Hôpitaux de Paris
Le Kremlin Bicêtre, France, 94275
Hôpital Necker, Assistance Publique des Hôpitaux de Paris
Paris, France, 75015

Michaël HOCQUEMILLER, PhD
Program Management
Scientific & Clinical Affairs
LYSOGENE
52 rue la Boétie 75008 PARIS

Tel : + 33 1 56 88 52 84
www.lysogene.com

Alliance Sanfilippo coordinated discussions between researchers and clinicians susceptible of being interested in developing a similar clinical trial for Sanfilippo Syndrome type IIIA. All of them expressed their desire to work together in exchanging expertise, reagents and preclinical data
Gene therapy program for intracerebral administration of an adeno-associated virus vector to replace Sulfamidase enzyme missing in Sanfilippo A patients. The program is structured in phases with synergized management of activities and partnerships:

  • Construction and validation of an adeno-associated vector with good brain tropism: a AAV vector (serotype 10) encoding human SGSH and SUMF1 cDNA for treatment of type IIIA Sanfilippo syndrome
  • Effectiveness studies carried out on mouse models
  • Vector production according to GMP (Good Manufacturing Practice) quality standards
  • Regulation toxicological studies
  • Preparation of a protocol for open,phase I/II clinical trials to assess the tolerance of intracerebral administration of this adeno-associated vector to treat type IIIA Sanfilippo syndrome
  • Management of regulatory affairs in cooperation with the competent health authorities

Study launched under the express condition that proper authorization be granted by health authorities
The phase I/II trial will be start on August 2011. 4 Children, 18 months to 6 years.

Chaperone Therapy Sanfilippo B
CNRS / UMR
Dr. Matthieu Sollogoub matthieu.sollogoub@upmc.fr

Conception and evaluation of new chemical chaperones of the N-acetyglucosaminidase in the context of the development of a treatment for Sanfilippo Syndrome (MPS III B).

This research and development project, organized by the team of Professor Matthieu Sollogoub (CNRS / UMR, Université Pierre and Marie Curie, Paris), consists of developing glycosidic inhibitors of the N-acetyglucosaminidase.

It is expected that these new molecules will be able to correct the structure and intracellular transport of certain mutated forms of the N-acetyglucosaminidase and therefore restore the ability to degrade heparan sulfate.

The Swiss Sanfilippo Foundation create a commercial company, SanOrphan, in February 2011 in order to raise more funds from venture capital in relation to the program of Dr. Sollogoub, the aim is to perform trial as soon as possible. (http://www.sanorphan.com – website under construction)

Research Projects – Canada

February 15, 2012 by Team Sanfilippo

Chaperone Therapy for Sanfilippo C
Ste-Justine Hospital
Dr.Alexey Pshezhetsky alexei.pchejetski@umontreal.ca

The concept of the chaperone therapy is a novel idea in which a lead molecule is nominated from a library of candidates. This molecule is small enough to breach the Blood-Brain Barrier (BBB). Once the molecule enters the body it is attracted to the enzyme and theoretically will enter the enzyme and “prop up” the folded part of its mutation. This will allow the enzyme to pass through the cell and enter the body, where it can perform its job of breaking down the substrate, also called a sugar molecule. In our case that substrate is known as Heparan Sulfate. The molecule used for the chaperone therapy doesn’t perform like an average drug. It’s the shape of the molecule that matters here. We need an exact fit to help our kids, who have specific folds in their enzyme Partial restoration of the deficient activity of N-acetyltransferase, even if modest, could help alleviate the disease symptoms or drastically slow the disease progression. Experiments using patients cells demonstrated that glucosamine could partially restore the protein folding defect and increase its activity.

These results, published in the recent issue of PLoS ONE (Matthew Feldhammer, Stéphanie Durand and Alexey V. Pshezhetsky Protein Misfolding as an Underlying Molecular Defect in Mucopolysaccharidosis III Type C PLoS ONE, October 13th, 2009; http://dx.plos.org), may provide future therapeutic solutions for this devastating untreatable disease.

Recently, Pshezhetsky was awarded a grant of $650,000 from the Canadian Institute of Health.

Research Projects – Australia

February 15, 2012 by Team Sanfilippo

Intrathecal Enzyme Replacement Sanfilippo A
Women’s and Children’s Hospital Adelaide
Dr. Kim Helmsley kim.hemsley@adelaide.edu.au
See Shire under United Kingdom. This clinical trial resulted from work originating from Australia

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