02.07.2018

MagForce Announces Enrollment of First Patient in its Pivotal, Three-Stage, Single-Arm Study of Focal Ablation of Prostate Cancer with NanoTherm Therapy

  • Single arm study will include up to 120 men under active surveillance which have progressed to intermediate risk prostate cancer
  • The objective of the study is to demonstrate that focal NanoTherm therapy can ablate prostate cancer lesions

 

Berlin, Germany, and Nevada, USA, July 2, 2018 - MagForce AG (Frankfurt, Scale, Xetra: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, together with its subsidiary MagForce USA, Inc. today announced MagForce USA has enrolled the first patient in its pivotal clinical evaluation with the Company's innovative NanoTherm selective ablation. Following the Investigational Device Exemption (IDE) approval by the US Food and Drug Administration (FDA) announced earlier this year, recruitment in the trial is underway at the two trial sites, the CHRISTUS Santa Rosa Hospital - Medical Center and the University of Washington.

 

The purpose of this focal thermal ablation registration study that will enroll up to 120 men in a single arm study is to demonstrate that NanoTherm therapy can focally ablate cancer lesions with minimal side effects for patients who have progressed to intermediate risk prostate cancer stage and are under active surveillance. By focally ablating these cancer lesions, it is anticipated that patients will be able to be maintained in Active Surveillance Programs and to avoid definitive therapies such as surgery or whole gland radiation with their well-known side effects.

 

NanoTherm therapy represents a new concept for interstitial hyperthermia of the prostate. This method is based on the controlled transfer of energy from an alternating magnetic field to biocompatible, superparamagnetic nanoparticles injected into the tumor. The resulting amount of heat generated is suitable to directly destroy cancer cells.

 

The study will be conducted at medical centers in the US, where NanoActivator devices have been installed: at the University of Washington in Seattle, and the CHRISTUS Santa Rosa Hospital - Medical Center in San Antonio, Texas. Dr. Ian M. Thompson, Jr., President of CHRISTUS Santa Rosa Hospital - Medical Center and Director Cancer Therapy and Research Center, a National Cancer Institute-designated Cancer Center at the University of Texas Health Science Center at San Antonio, and Dr. Dan W. Lin, Chief of Urologic Oncology and Professor in the Department of Urology at the University of Washington School of Medicine in Seattle, have agreed to be co-principal investigators in the Focal Thermal Ablation Registration study.

 

"Enrolling our first patient in this clinical study marks an important milestone for MagForce and is a significant step towards the approval of NanoTherm therapy for the treatment of prostate cancer patients in the USA. The NanoTherm trial in prostate cancer is designed to provide definitive safety and effectiveness data on our innovative therapy. We are very confident that the data from our planned prostate cancer study will fulfill all requirements for commercial registrations," commented Ben Lipps, CEO of MagForce AG and MagForce USA, Inc.

 

About Active Surveillance Progams

Within the past two decades, Active Surveillance Programs have been developed in the USA to follow the slow growth of Prostate Cancer in order to avoid the side effects of definitive therapy (radiation or surgery), for as long as possible. Currently, there are over 250 Active Surveillance Programs in the USA. Active Surveillance is the merging of watchful waiting and active management into a program that is interactive for the patient, ultimately allowing a man diagnosed with Prostate Cancer to monitor his disease and have the highest quality of life possible while delaying or even completely avoiding invasive treatments.

 

For the past decade, these Active Surveillance Programs have been seeking a focal therapy which would ablate the small tumors that have progressed to the intermediate risk stage because approximately 60% of the patients in Active Surveillance Programs who have participated in these programs for an extended period of time require definitive therapy such as whole gland surgery or radiation.

 

About MagForce AG and MagForce USA, Inc.

 

MagForce AG, listed in the Scale segment of the Frankfurt Stock Exchange (MF6, ISIN: DE000A0HGQF5), together with its subsidiary MagForce USA, Inc. is a leading medical device company in the field of nanomedicine focused on oncology. The Group's proprietary NanoTherm(R) therapy enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles.

 

NanoTherm(R), NanoPlan(R), and NanoActivator(R) are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of brain tumors. MagForce, NanoTherm, NanoPlan, and NanoActivator are trademarks of MagForce AG in selected countries.

 

For more information, please visit: www.magforce.com.

Get to know our Technology: video (You Tube)

 

Disclaimer

This release may contain forward-looking statements and information which may be identified by formulations using terms such as "expects", "aims", "anticipates", "intends", "plans", "believes", "seeks", "estimates" or "will". Such forward-looking statements are based on our current expectations and certain assumptions, which may be subject to a variety of risks and uncertainties. The results actually achieved by MagForce AG may substantially differ from these forward-looking statements. MagForce AG assumes no obligation to update these forward-looking statements or to correct them in case of developments, which differ from those, anticipated.

 

Contact:

Barbara von Frankenberg
Vice President
Communications & Investor Relations

T +49-30-308380-77
E-Mail:

 

14.06.2018

MagForce AG Co-Sponsors the University Hospital of Münster’s Annual Brain Cancer Patient Event

Berlin, Germany and Nevada, USA, June 14, 2018 - MagForce AG (Frankfurt, Scale, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, is delighted to announce that the Company will again co-sponsor an event for brain cancer patients and their relatives held on the occasion of the 2018 World Brain Tumor Day. The event will be hosted by the University Hospital of Münster’s Brain Tumor Center and will take place on June 16, 2018.

 

Under the slogan “Wieder unterwegs! Von der Klinik in die Welt (On the road again! From the clinic into the world)” this year’s event will feature speeches from brain tumor patients reporting on their travels after diagnosis. Sharing their experiences, both trying and beautiful, with others affected by the disease, the 2018 event is dedicated to encouraging brain tumor patients, and their loved ones, to overcome not only national borders but also their own fears.

 

The event will take place at the Restaurant Bakenhof in Münster, Germany, on Saturday, June 16, 2018, from 10am to 2pm CEST. MagForce will be available for questions regarding its NanoTherm therapy for the treatment of brain tumors and will be represented by an informational booth at the venue.

 

The University Hospital of Münster was the second medical center in Germany to install a NanoActivator device, following the Charité University Hospital in Berlin. Recently, the Team of Prof. Dr. med. Walter Stummer, Director of the Neurosurgery Department at the University Hospital Münster and Chair of the UKM Brain Tumor Centre, which has been treating brain tumor patients with MagForce’s NanoTherm Therapy since early 2015, reported their experiences with NanoTherm therapy during a symposium entitled “Local Therapies for Malignant Gliomas” at the 69th Annual Meeting of the German Society of Neurosurgery, DGNC 2018. MagForce was pleased by the significant interest in the symposium and NanoTherm therapy reflected by more than 120 attendees from the scientific and medical community. Increased attention shown by a number of clinics and first-class neurosurgeons from other European countries is especially valuable to MagForce, since the Comapny continues to expand its commercialization to further European sites in order to allow patients treatment with NanoTherm therapy in their home countries.

 

For further information regarding the program (German only) and registration, please visit: https://bit.ly/2kIIst4 

 

Role of NanoTherm Therapy in the Treatment of Brain Tumors

NanoTherm therapy is an intratumoral thermotherapy which aims to help patients with brain tumors. With NanoTherm therapy, the paramagnetic fluid injected into a tumor is heated through a very fast alternating magnetic field. Through the heat, tumor cells are either destroyed or sensitized for additional therapies such as radiotherapy and/or chemotherapy; thus, the efficacy of the additional therapies is improved.

 

MagForce AG has CE mark (European Certification) in Germany and in the EU 28 to treat brain tumors with NanoTherm therapy.

 


About the World Brain Tumor Day

This commemoration day was initialised by the Deutsche Hirntumorhilfe e.V. (German Brain Tumor Association) in 2000. Because brain tumors occur rather seldom in comparison to other cancers, they are little-noticed by the public. With the aim of directing public attention to the situation of brain tumor patients and appealing for solidarity with patients and their dependants, the World Brain Tumor Day takes place every year on June 8th. It is also a reminder directed at the responsible persons in the fields of politics and economy to assume their social responsibility. Active support of research and an increased interdisciplinary collaboration are the ways to develop new therapies and improve the chances of healing. Until that, it is essential to campaign together to advance the quality of life of patients, to give hope and show solidarity – it is essential to send a signal.

 


About MagForce AG and MagForce USA, Inc.

MagForce AG, listed in the Scale segment of the Frankfurt Stock Exchange (MF6, ISIN: DE000A0HGQF5), together with its subsidiary MagForce USA, Inc. is a leading medical device company in the field of nanomedicine focused on oncology. The Group's proprietary NanoTherm® therapy enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles.

 

NanoTherm®, NanoPlan®, and NanoActivator® are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of brain tumors. MagForce, NanoTherm, NanoPlan, and NanoActivator are trademarks of MagForce AG in selected countries.


For more information, please visit: www.magforce.com.      

Get to know our Technology: video (You Tube)

 

Disclaimer      

This release may contain forward-looking statements and information which may be identified by formulations using terms such as "expects", "aims", "anticipates", "intends", "plans", "believes", "seeks", "estimates" or "will". Such forward-looking statements are based on our current expectations and certain assumptions, which may be subject to a variety of risks and uncertainties. The results actually achieved by MagForce AG may substantially differ from these forward-looking statements. MagForce AG assumes no obligation to update these forward-looking statements or to correct them in case of developments, which differ from those, anticipated.

 

12.06.2018

MagForce AG Announces Collaboration Agreement for NanoTherm® Therapy with Independent Public Clinical Hospital No. 4, Lublin, Poland

Berlin, Germany and Nevada, USA, June 12, 2018 - MagForce AG (Frankfurt, Scale, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, today announced that it has entered into a collaboration agreement with Independent Public Clinical Hospital No. 4 in Lublin, Poland, one of the most prestigious brain treatment centers in Poland.

 

Pursuant to the agreement, Independent Public Clinical Hospital No. 4 will introduce and provide access for brain cancer patients to be treated with NanoTherm® therapy in Poland. For this purpose a mobile container with a NanoActivator® device will be installed in the hospital in Lublin. Commercial treatment is anticipated to commence in the course of 2018. The NanoTherm® treatment center at Independent Public Clinical Hospital No. 4 will be headed by Prof. Dr. hab. n. med. Tomasz Trojanowski, Head and Chairman of the Department of Neurosurgery and Paediatric Neurosurgery, State Consultant in Neurosurgery and a member of the Scientific Advisory Board of the Minister of Health, with the support of his renowned medical team of qualified and experienced doctors and nurses.

 

The Independent Public Clinical Hospital No. 4 in Lublin is the largest hospital in Lublin Province, providing learning and research facilities for the Medical University in Lublin. The hospital serves patients from Lublin province as well as from other regions of the country and abroad. Over 1,600 patients are operated yearly, and about 6,000 consultations are given in an outpatient neurosurgical clinic.

 

The cooperation agreement with Independent Public Clinical Hospital No. 4 is MagForce’s first collaboration outside of Germany as part of MagForce’s European roll-out plan and will allow Polish patients to be treated with NanoTherm® therapy in their home country; providing faster access to the therapy after diagnosis. Due to the aggressive nature of glioblastoma, timely availability is a decisive factor in the treatment of brain tumors as there is only a narrow window for patients to receive treatment. To provide accelerated treatment options, MagForce’s European roll-out plan aims to place its NanoActivator® devices in a number of European countries. The development of a mobile solution for the placement of NanoActivator® devices, as is the case at Independent Public Clinical Hospital No. 4 in Lublin, enables MagForce to place the devices sooner and more cost-effectively in suitable treatment centers all over Europe.

 

The collaboration with Independent Public Clinical Hospital No. 4 in Lublin will be supported by the efforts of the Alivia Cancer Foundation, Poland. The Foundations’s mission is to mobilize, empower and educate cancer patients as well as give them the tools and necessary means to make decisions regarding their own health.

 

We are delighted to team up with Prof. Dr. Tomasz Trojanowski and his team at the renowned Independent Public Clinical Hospital No. 4, the first collaboration agreement for our NanoTherm® therapy with a clinic outside of Germany. Over the past year, our Market Development team, headed by Dr. Katarzyna Zarychta, Vice President Oncology Market Development Europe, has worked diligently to identify and build relationships with possible partner hospitals in further European countries as part of our European roll-out plan. The collaboration with Independent Public Clinical Hospital No. 4 in Poland, one of the initial target countries of this plan, is the first result of our dedicated marketing efforts,“ said Ben Lipps, Chief Executive Officer of MagForce AG and MagForce USA, Inc. “Brain treatment inquiries from patients in Poland, Germany and Italy have continued to increase with approximately 60 percent of the patients who could qualify for NanoTherm® therapy being from Poland. We are therefore very excited, that we will be able to provide patients from Poland and from surrounding countries with an additional treatment option and to be working with Prof. Trojanowski and his team with their exceptional experience and knowledge. With further negotiations underway, we are confident, that we will be able to announce more cooperations with clinics outside of Germany in the course of the year.”

 

“My Team and I are excited to be working together with MagForce to make NanoTherm® therapy available to patients from Poland and other surrounding countries. NanoTherm® is a promising, novel approach to the treatment of brain cancer - stand alone or for the enhancement of effects of standard therapy - and could become a valuable option for patients diagnosed with the disease,”  said Prof. Trojanowski, Head and Chairman of the Department of Neurosurgery and Paediatric Neurosurgery at Independent Public Clinical Hospital No. 4.

 

About MagForce AG and MagForce USA, Inc.

MagForce AG, listed in the Scale segment of the Frankfurt Stock Exchange (MF6, ISIN: DE000A0HGQF5), together with its subsidiary MagForce USA, Inc. is a leading medical device company in the field of nanomedicine focused on oncology. The Group's proprietary NanoTherm® therapy enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles.

NanoTherm®, NanoPlan®, and NanoActivator® are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of brain tumors. MagForce, NanoTherm, NanoPlan, and NanoActivator are trademarks of MagForce AG in selected countries.

 

For more information, please visit: www.magforce.com.      

Get to know our Technology: video (You Tube)

 

Disclaimer      

This release may contain forward-looking statements and information which may be identified by formulations using terms such as "expects", "aims", "anticipates", "intends", "plans", "believes", "seeks", "estimates" or "will". Such forward-looking statements are based on our current expectations and certain assumptions, which may be subject to a variety of risks and uncertainties. The results actually achieved by MagForce AG may substantially differ from these forward-looking statements. MagForce AG assumes no obligation to update these forward-looking statements or to correct them in case of developments, which differ from those, anticipated.

 

04.06.2018

MagForce AG to host Lunch Symposium about Local Therapies for Malignant Gliomas at the 2018 meeting of the German Society of Neurosurgery (DGNC)

Berlin, Germany and Nevada, USA, June 4, 2018 - MagForce AG (Frankfurt, Scale, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, is pleased to announce that it will host a scientific lunch symposium titled “Local Therapies for Malignant Gliomas” at the 69th Annual Meeting of the German Society of Neurosurgery (DGNC). The joint meeting with the Mexican Society of Neurological Surgery (MSNS) and Colombian Association of Neurosurgery (ACNCX) is held from June 3 - 6, 2018, in Münster, Germany.

 

Chaired by Prof Dr Walter Stummer, Director of the Department of Neurosurgery at the University Hospital Münster, Germany, the one hour lunch symposium will be held Tuesday, June 5 from 12:30 - 1:30 p.m. CEST and will feature three key note speeches: Besides an introduction of the current status of local therapies for malignant glioblastoma by Prof. Dr. Walter Stummer, PD Dr. Johannes Woelfer, Chief Physician at Hufeland Klinikum Muelhausen, and PD Dr. Dr. Oliver Grauer, Head of Neuro-Oncology at the Department of Neurology at the University Hospital Münster, will be discussing technical aspects of applying Nanotherm therapy with malignant gliomas tumor resections as well as immunological aspects and future approaches with regard to intracavitary thermotherapy with superparamagnetic iron oxide nanoparticles.

 

The symposium details are as follows: 

Title:

“Local Therapies for Malignant Gliomas”

Date:

Tuesday, June 5, 2018

Time:

12:30 – 1:30 p.m. CEST

Location:

Roter Saal 1, Messe und Congress Centrum Halle Münsterland, Münster

Speakers:

Prof. Dr. Walter Stummer (Chair/Moderation)
University Hospital Münster
Local therapies for malignant gliomas: Current status

PD Dr. Johannes Woelfer
Hufeland Klinikum Muelhausen
lntracavitary thermotherapy with superparamagnetic iron oxide
nanoparticles: Technical aspects and NanoPaste technique

 

PD Dr. Dr. Oliver Grauer
University Hospital Münster
lntracavitary thermotherapy with superparamagnetic iron oxide nanoparticles: lmmunological aspects and future approaches

In addition, MagForce will be represented with a booth (Booth No. 2, Nordfoyer, Main Exhibition) at the 2018 DGNC and will be available for questions regarding its NanoTherm therapy for the treatment of glioblastoma and other brain tumors.

 

Focal Therapy is an important option in the treatment of glioblastoma. These tumors are the most common and most aggressive brain tumors. In Europe, over 20,000  glioblastoma cases are diagnosed each year. Prognosis for glioma patients is still dim as often times, even after the most successful surgery, residual microscopic tumor remains and usually regrows in direct vicinity of the original resection cavity. For more local control of remaining tumour infiltration, the concept of thermotherapy for tumor ablation and as a radiosensitiser in glioma therapy could be very promising.

 

For more information on the 2018 DGNC Meeting programme, please click here.

 

 

About the 69th Annual Meeting of the German Society of Neurosurgery (DGNC)

The 69th Annual Meeting of the German Society of Neurosurgery held in Münster, Germany, from June 3–6, 2018 at the Messe und Congress Centrum Halle Münsterland in Münster, will be the first joint meeting with two Latin American Societies, the Mexican Society of Neurological Surgery and the Colombian Association of Neurosurgery.

 

Leading neurosurgeons will present scientific findings, discuss new innovative treatments and exchange information about the most recent research results and future visions. The scientific programme of the annual meeting reflects a wide range of aspects on key areas of the neurosurgical field. Next to the main topic spinal surgery, the 69th Annual Meeting will be focusing on neuro-oncology, including the rapidly expanding field of intra-operative imaging. The scientific programme is complemented by plenty of workshops, satellite symposia and plenary sessions.

 

 

About MagForce AG and MagForce USA, Inc.

MagForce AG, listed in the Scale segment of the Frankfurt Stock Exchange (MF6, ISIN: DE000A0HGQF5), together with its subsidiary MagForce USA, Inc. is a leading medical device company in the field of nanomedicine focused on oncology. The Group's proprietary NanoTherm® therapy enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles.

 

NanoTherm®, NanoPlan®, and NanoActivator® are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of brain tumors. MagForce, NanoTherm, NanoPlan, and NanoActivator are trademarks of MagForce AG in selected countries.

 

Get to know our Technology: video (You Tube)

 

 

Disclaimer      

This release may contain forward-looking statements and information which may be identified by formulations using terms such as "expects", "aims", "anticipates", "intends", "plans", "believes", "seeks", "estimates" or "will". Such forward-looking statements are based on our current expectations and certain assumptions, which may be subject to a variety of risks and uncertainties. The results actually achieved by MagForce AG may substantially differ from these forward-looking statements. MagForce AG assumes no obligation to update these forward-looking statements or to correct them in case of developments, which differ from those, anticipated.