GT Medical Technologies Announces Completion of First Case in Arizona to Use GammaTile Therapy

On August 15, 2019 HonorHealth Scottsdale Osborn Medical Center is the first hospital in Arizona to begin offering GammaTile Therapy, a new approach to treating recurrent brain tumors (Press release, GT Medical Technologies, AUG 15, 2019, View Source [SID1234538788]). GammaTile Therapy is an FDA-cleared, surgically targeted radiation therapy (STaRT) that is designed to delay tumor regrowth for patients with all types of recurrent brain tumors. The first patient was treated by John Wanebo, M.D., a neurosurgeon and an independent member of the HonorHealth medical staff.

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"The first patient I was able to treat with GammaTile Therapy had a very large, aggressive meningioma that has recurred several times," Dr. Wanebo said. "I am pleased to be able to offer this patient GammaTile Therapy – a treatment proven to delay brain tumor recurrence and improve quality of life. This therapy was developed with patients like this in mind, and I am hopeful that it will make a meaningful difference."

Data supporting the efficacy and safety profile of the therapy for patients with recurrent, previously treated meningiomas were published earlier this year in the Journal of Neurosurgery (JNS), the official journal of the American Association of Neurological Surgeons. Clinical data from other types of tumors, including gliomas, glioblastomas and metastases, were presented at the AANS Annual Scientific Meeting in April.

Aggressive brain tumors tend to be resistant to current treatments and nearly always recur. Outcomes for patients with brain tumors have improved very little over the past 30 years. GammaTile consists of a bioresorbable, conformable 3D-collagen tile embedded with a Cesium radiation source. GammaTile is placed at the time of surgery so that it immediately begins to target residual tumor cells with radiation while limiting the impact on healthy brain tissue.

GammaTile Therapy offers some advantages over other treatments for patients undergoing surgery for recurrent brain tumors. A course of External Beam Radiation Therapy (EBRT), for example, requires daily treatments for up to six weeks; in contrast, patients treated with GammaTile Therapy require no additional trips to the hospital or clinic. Additionally, many patients may not be candidates for EBRT at the time of tumor recurrence because the risk of additional EBRT outweighs the potential benefits. Finally, those patients who may be candidates for EBRT typically have to wait several weeks for surgical wound healing before beginning treatment, allowing residual tumor cells to replicate during this waiting period.

"We are thrilled to see GammaTile Therapy offered in Arizona – our home state, and the place where our co-founders first developed this therapy," said Matt Likens, president and CEO of GT MedTech. "Many patients with recurrent brain tumors have run out of options. Through the elegantly simple approach of GammaTile Therapy, we hope to create a new standard of care for these patients. Our purpose is to improve the lives of patients with brain tumors, and we are excited to continue delivering on this purpose by expanding the availability of GammaTile Therapy across the U.S."

NOXXON Announces Completion of €1 Million Capital Increase

On August 15, 2019 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that the previously announced capital increase of €1 million through a private placement of shares without warrants (see press release of August 6, 2019) has been completed and that further investment is already committed for a future investment round (Press release, NOXXON, AUG 15, 2019, View Source [SID1234538786]).

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"We are pleased to announce the completion of the capital increase, which has placed NOXXON in a solid position that will facilitate the advancement and initiation of the Phase 1/2 clinical trial in brain cancer. We are working at full speed to open the clinical trial sites in Germany where the trial has already been approved by the regulatory authorities and Ethics Committees. In parallel, we are in active discussions regarding additional financing, industry partnerships and M&A," said Aram Mangasarian, CEO of NOXXON.

Trovagene to Present New Data from Onvansertib Phase 2 Study in Metastatic Castration-Resistant Prostate Cancer at Asia-Pacific Prostate Cancer Conference

On August 15, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company, developing drugs that target cell division (mitosis), for the treatment of various cancers, including prostate, colorectal and leukemia, reported that new clinical data from its Phase 2 trial of onvansertib, in combination with Zytiga (abiraterone acetate)/prednisone, in metastatic Castration-Resistant Prostate Cancer (mCRPC), will be presented as an oral poster at the 20th Asia-Pacific Prostate Cancer Conference, which will be held August 23-26 in Melbourne, Australia (Press release, Trovagene, AUG 15, 2019, View Source [SID1234538785]).

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The data will be presented in an oral, moderated poster session on Saturday, August 24, 2019 at 1:00 pm (AEDT)

Details of the Trovagene Poster Presentation are as follows:

Title: A Phase 2 Study of the Combination of PLK1 Inhibitor, Onvansertib, with Abiraterone and Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Abstract Number: 1044

Moderated Poster Session: Clinical Urology

Location: Goldfields Exhibition

FDA grants IDE approval to use Oncology Venture’s LiPlaCis DRP for patient selection in a pivotal Phase 3 study

On August 15, 2019 Oncology Venture A/S (Nasdaq First North Stockholm: OV.ST) reported that the US Food & Drug administration & Drug administration (FDA) has approved an IDE (Investigational Device Exemption) application for use of the company’s drug response predictor LiPlaCis DRP in a planned pivotal Phase 3 study (Press release, Oncology Venture, AUG 15, 2019, View Source [SID1234538784]). In parallel, the FDA is evaluating Oncology Venture’s IND (Investigational New Drug) application for the drug substance LiPlaCis, which is primarily being developed as a potential new treatment of metastatic breast cancer in heavily pre-treated patients.

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Oncology Venture’s drug candidate LiPlaCis is a third-generation intelligent liposomal formulation of cisplatin, enabling direct delivery to the tumour site. LiPlaCis is being developed in combination with a specific drug response predictor, LiPlaCis DRP, which includes 205 genes and predicts the treatment response in individual patients based on a pre-treatment biopsy. Treatment of patients with LiPlaCis selected by the DRP continues to deliver encouraging results in an ongoing Phase 2 study.

The FDA is currently evaluating Oncology Venture’s IND (Investigational New Drug) application for the drug substance LiPlaCis. Oncology Venture has recently provided the authority with supplementary information on the characteristics of LiPlaCis and has an ongoing dialogue with the authority on the details of the pivotal Phase 3 study design.

"The FDA approval to use Oncology Venture’s drug response prediction technology, DRP, in a pivotal Phase 3 study of LiPlaCis in the US is a major step forward in establishing our unique concept of precision medicine", says Peter Buhl Jensen, M.D., CEO of Oncology Venture.

For further information, please contact:

For investor inquiries
Ulla Hald Buhl, IR & Communications
E-mail: [email protected]
Telephone +45 21 70 10 49

For media inquiries
Thomas Pedersen, Carrotize PR & Communications
E-mail: [email protected]
Telephone +45 60 62 93 90

About the Drug Response Predictor – DRP Companion Diagnostic
Oncology Venture uses its multi gene DRP to select those patients who by the genetic signature of their cancer are found to have a high likelihood of responding to the drug. The goal is developing the drug for the right patients, and by screening patients before treatment the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. DRP is based on messenger RNA from the patients’ biopsies.
DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 29 out of 37 clinical studies that were examined and is currently demonstrating promising results in an ongoing phase 2 study prospectively using LiPlaCis and its DRP to track, match and treat patients with metastatic breast cancer.
The DRP platform, i.e. the DRP and the PRP tools, can be used in all cancer types and is patented for more than 70 anti-cancer drugs in the US. The PRP is used by Oncology Venture for Personalized Medicine. The DRP is used by Oncology Venture for drug development.

BIO-TECHNE TO PRESENT AT THE BAIRD 2019 GLOBAL HEALTHCARE CONFERENCE

On August 15, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Baird 2019 Global Healthcare Conference on Wednesday, September 4, 2019, at 10:15 a.m. EDT (Press release, Bio-Techne, AUG 15, 2019, View Sourcepress-releases/detail/155/bio-techne-to-present-at-the-baird-2019-global-healthcare" target="_blank" title="View Sourcepress-releases/detail/155/bio-techne-to-present-at-the-baird-2019-global-healthcare" rel="nofollow">View Source [SID1234538783]). The conference will be held at the Intercontinental New York Barclay in New York, NY.

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Chuck Kummeth

A live webcast of the presentation can be accessed via Bio-Techne’s Investor Relations website at View Source or through the following link View Source