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Enteris BioPharma and Nordic BioScience’s KeyBioScience Enter Strategic Licensing Agreement to Develop Metabolic Peptides Using Enteris’ Proprietary Oral Drug Delivery and Manufacturing Platform

Enteris BioPharma, Inc., an industry leader in innovative oral dosage formulations, and KeyBioScience, a wholly-owned subsidiary of Nordic Bioscience, recently announced a strategic licensing agreement for Enteris’ oral drug delivery and recombinant manufacturing technologies to advance the development of KeyBioScience’s recently acquired family of proprietary metabolic peptides for various indications, including the treatment of Type 2 diabetes, obesity and other inflammatory conditions with high unmet medical and socioeconomic needs.

FDA Grants Genentech’s Perjeta Accelerated Approval for Use Before Surgery in People With HER2-Positive Early Stage Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. This approval is based primarily on data from a Phase II study showing that nearly 40 percent of people receiving the combination of Perjeta, Herceptin® (trastuzumab) and docetaxel chemotherapy had no evidence of tumor tissue detectable at the time of surgery (known as a pathological complete response, or pCR). The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the FDA and also the first to be approved based on pCR data.

Researchers Develop Specific Tests to Identify Cancer Biomarkers in Dermatomyositis

Researchers from major universities in the U.S. have developed specific tests to identify cancer biomarkers in patients with dermatomyositis—a systemic inflammatory disease associated with increased risk of malignancy. According to study findings published in the American College of Rheumatology (ACR) journal, Arthritis & Rheumatism, the assays detect antibodies against anti-transcriptional intermediary factor-1 (TIF-1γ) and nuclear matrix protein NXP-2.

Patients with dermatomyositis experience muscle weakness, skin inflammation, and sometimes inflammation of the lung. Most patients with dermatomyositis have auto-antibodies circulating in their bodies that cause distinct clinical disease features. Medical evidence suggests that these auto-antibodies in dermatomyositis patients stem from specific immune responses that shape various characteristics (phenotypes). In addition, up to 20% of those with dermatomyositis are at increased risk of malignancies.

“For the physician treating patients with dermatomyositis, identifying those at higher risk for cancer is a top priority,” explains Dr. David Fiorentino from Stanford University in Redwood City, Cal. “Our team focused on creating specific tests to detect antibodies against two specific proteins and then testing if those antibodies can identify dermatomyositis patients at higher risk of cancer.”

The team used both immunoblotting and immunoprecipitation techniques to detect antibodies against TIF-1γ and NXP-2 proteins. Blood analysis was performed on 111 patients from Stanford University Dermatology Clinic and 102 patients from the Johns Hopkins University (JHU) Myositis Center. Both groups were similar in gender and age at diagnosis.

Results show that 17% and 38% of subjects in the two cohorts combined had antibodies against NXP-2 and TIF-1γ, respectively. Using the specific assays, researchers found 83% of dermatomyositis patients with cancer had a reaction to NXP-2 or TIF-1γ. Further analysis indicates that cancer, older age, and male gender were linked to NXP-2 or TIF-1γ antibodies, with anti-NXP-2 specifically associated with cancer in men.

“Our findings confirm the link between cancer and age in dermatomyositis, with a sharp increase in frequency at roughly 60 years of age.” concludes Dr. Fiorentino. “By determining the presence or absence of NXP-2 and TIF-1γ antibodies, we believe that this will aid clinicians in identifying those with the highest cancer risk.”

Study: Most patients with cancer-associated dermatomyositis have antibodies to nuclear matrix protein NXP-2 or transcription intermediary factor 1-gamma [Arthritis & Rheumatism]

Source: EurekAlert!

VolitionRx-led Consortium Awarded €780 000 ($1M approx.) Eurostars Grant

VolitionRx Limited (OTC: VNRX), a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, is lead partner of a consortium in a project valued at €779,493 (approx. US$1M) under the EUREKA Eurostars scheme. The project aims to develop new applications of the Nucleosomics biomarker technology in inflammatory disease. The research will build on VolitionRx’s ongoing cancer diagnostic research program.

VolitionRx’s contribution to the project is to develop novel NuQ® biomarkers for immune response. VolitionRx will use its proprietary Nucleosomics® platform for biomarker development exploiting UK-based Alcyomics’ proprietary ex-vivo SkimmuneTM model.

The Eurostars Programme is a European innovation program managed by EUREKA. It is the first program dedicated to supporting research-based small- and medium-sized companies (SMEs) from across Europe. To be eligible for the grant, companies must form a consortium of at least two companies from different European countries, with the aim of developing a civilian-purposed new product, process or service.

“The Eurostars scheme is a prestigious European program designed to support SMEs like VolitionRx, and to encourage cross-border research and development collaboration,” says Mark Eccleston, VolitionRx’s External Collaborations Manager. “We are looking forward to working with our partners to develop novel applications for our Nucleosomics technology, while complementing our ongoing research in cancer diagnostics.”

Under the grant, VolitionRx will be reimbursed with 80% of the costs associated with its share of the joint project – €420,000 ($0.56M approx.) over two years.

Source: VolitionRx Limited

Brain Inflammation Linked to More Severe Parkinson’s Symptoms

Reversing inflammation in the fluid surrounding the brain’s cortex may provide a solution to the complex riddle of Parkinson’s, according to researchers who have found a link between pro-inflammatory biomarkers and the severity of symptoms such as fatigue, depression and anxiety in patients with the chronic disease.

Lena Brundin of Michigan State University’s College of Human Medicine was part of a research team that measured inflammatory markers found in cerebrospinal fluid samples of Parkinson’s patients and members of a control group.

“The degree of neuroinflammation was significantly associated with more severe depression, fatigue, and cognitive impairment even after controlling for factors such as age, gender and disease duration,” said Brundin, an associate professor in the college and a researcher with the Van Andel Institute.

“By investigating associations between inflammatory markers and non-motor symptoms we hope to gain further insight into this area, which in turn could lead to new treatment options.”

The results of the study were published in the journal Brain, Behavior, and Immunity.

Inflammation in the brain long has been suspected to be involved in the development of Parkinson’s disease, specifically in non-motor symptoms such as depression, fatigue and cognitive impairment. Recent research suggests inflammation could drive cell death and that developing new drugs that target this inflammation might slow disease progression.

Parkinson´s disease is the second most common degenerative disorder of the central nervous system; the causes of the disease and its development are not yet fully understood.

“The few previous studies investigating inflammatory markers in the cerebrospinal fluid of Parkinson’s patients have been conducted on comparatively small numbers of subjects, and often without a healthy control group for comparison,” Brundin said.

In the study, 87 Parkinson’s patients were enrolled between 2008 and 2012. For the control group, 37 individuals were recruited. Participants underwent a general physical exam and routine blood screening. Researchers looked at the following markers: C-reactive protein, interleukin-6, tumor necrosis factor-alpha, eotaxin, interferon gamma-induced protein-10, monocyte chemotactic protein-1 and macrophage inflammatory protein 1-β.

The study was carried out in collaboration with researchers from Lund University in Sweden, Skåne University Hospital in Sweden and the Mayo Clinic College of Medicine in Florida.

Study: Cerebrospinal fluid inflammatory markers in Parkinson’s disease – Associations with depression, fatigue, and cognitive impairment [Brain, Behavior, and Immunity]

Source: EurekAlert!