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Saturday, September 15, 2018

Cancer Incidence Continues to Rise: 1 in 5 Men, 1 in 6 Women


In 2018, an estimated 18.1 million new cases cancer will be diagnosed globally, and 9.6 million will die from the disease, according to the latest report from the International Agency for Research on Cancer (IARC).
One in 5 men and one in 6 women worldwide will develop cancer during their lifetime, and one in 8 men and one in 11 women will die from cancer.
Cancer incidence and mortality are rapidly growing worldwide, the report notes.
“The increasing cancer burden is due to several factors, including population growth and ageing as well as the changing prevalence of certain causes of cancer linked to social and economic development,” the IARC commented in a statement. “This is particularly true in rapidly growing economies, where a shift is observed from cancers related to poverty and infections to cancers associated with lifestyles more typical of industrialized countries.”
Worldwide, the total number of people who are alive within 5 years of a cancer diagnosis (the 5-year prevalence) is estimated to be 43.8 million.
The GLOBOCAN 2018 database is part of the IARC Global Cancer Observatory. It provides estimates of incidence and mortality for 36 types of cancer in 185 countries, as well as for all cancer sites combined.
An analysis of these results was published online September 12 in CA: A Cancer Journal for Clinicians.
“These new figures highlight that much remains to be done to address the alarming rise in the cancer burden globally and that prevention has a key role to play,” commented IARC Director Christopher Wild, MD, in a statement. “Efficient prevention and early detection policies must be implemented urgently to complement treatments in order to control this devastating disease across the world.”

Global Patterns

GLOBOCAN 2018 estimates that almost half of all cases and over one half of related deaths will occur in Asia, partly because almost 60% of the global population resides on that continent. Europe accounts for almost a quarter (23.4%) of the total number of global cases and about a fifth (20.3%) of cancer-related mortality, but it comprises only 9% of the world population. The Americas account for 13.3% of the global population, with 21% of cancer incidence and 14.4% of related mortality.
Conversely, cancer deaths in Asia (57.3%) and Africa (7.3%) are much higher than the incidence (48.4% and 5.8%, respectively) in those regions, largely because of the distribution of cancer types and higher case fatality rates.
The incidence rate for all cancers combined was about 20% higher in men (age‐standardized rate [ASR], 218.6 per 100,000 person-years) than in women (ASR, 182.6 per 100,000), although there was substantial variation across regions.
For men, there was an almost sixfold difference, from 571.2 per 100,000 in Australia/New Zealand to 95.6 per 100,000 in Western Africa. Similar ranges were seen for women, with a nearly fourfold difference, from 362 per 100,000 in Australia/New Zealand to 96.2 per 100,000 in South‐Central Asia.

Lack of blood cancer awareness in China and Japan – Janssen report


Janssen has published a report revealing significant gaps in understanding of blood cancer in individuals in China and Japan, calling for action to improve awareness about the disease in the region.
The Make Blood Cancer Visible (MBCV) Asia Pacific report marked the beginning of an effort across the region to build awareness and support for those living with blood cancers such as lymphoma, leukaemia, and myeloma.
The report featured an independent survey of 3,000 individuals in China and Japan, and was conducted by YouGov and Nielsen.
Findings showed in both China and Japan, roughly half of people surveyed could not name a single symptom of blood cancer.
In Japan, only 1% of people surveyed recall hearing or reading anything about blood cancer in the last year.
And in China, four in 10 people surveyed wrongly believed blood cancer is contagious, or don’t know if it is contagious.
While low awareness could pose a significant obstacle to national efforts in prevention and early diagnosis, the survey also highlights that a large proportion of respondents want more information about prevention, treatment options and patient experiences.
The MBCV Asia Pacific survey asked 1,000 representatives of the general population in Japan and 2,000 representatives of the general population in China 15 questions about their general awareness and perceptions of blood cancer.
All questions had fixed answer categories and were online, self-administered surveys. To ensure anonymity, all respondents were assigned an anonymous alphanumeric identification to protect their identity. The study was conducted from 1 February 2018 to 8 February 2018 in both countries.
To shed light on the patient experience in Asia Pacific, the report also showcases a collection of thirteen blood cancer patient stories from across the region. They reveale that even at the time of diagnosis, many survivors were unable to identify a single symptom until their disease had progressed significantly.
The report was developed with the help of the blood cancer support organisation, The Max Foundation.
Mei Ching Ong
Mei Ching Ong, regional head for Asia Pacific at The Max Foundation, said: “Upon reading through the perceptions around blood cancer in China and Japan, I am reminded of how much work there is to do, not just in these countries but across the region.”

NVIDIA unveils next-gen medical imaging tech


Technology firm NVIDIA has unveiled its latest development in supercomputing, which will expand the way artificial intelligence (AI) is used in healthcare and medical imaging.
The company’s Clara platform combines hardware and software in AI applications that can be used for the early detection, diagnosis and treatment of diseases.
Clara allows the medical AI industry to “build and deploy breakthrough algorithms to create intelligent instruments and automate healthcare workflows.”
Unlike traditional computing, NVIDIA uses GPU (graphics processing unit) computing as opposed to that run via a CPU (central processing unit). GPUs allow vast amounts of information to be processed repeatedly, swiftly and efficiently.
One major advantage of this latest development is that the Clara platform will allow immense amounts of medical data to be generated each second, which will be valuable to those making diagnoses and who are working in pharma R&D.
Such rapid advances in AI are already helping start-ups in the field to make leaps when it comes to what they can achieve – and how quickly.
For instance, Subtle Medical uses AI to reduce the costs associated with imaging, by cutting down the time needed – as well as the amount of time patients spend inside PET and MRI scanners.
Through deep learning, Subtle Medical’s researchers have improved image quality, which means scans are faster and more accurate. MRI applications acquire images in one-quarter of the usual time and use only one-tenth of the contrast dosage, gadolinium, a potentially harmful metal, which is deposited in the body during MRI contrast scans. Research into the effects of gadolinium is ongoing.
Enhao Gong, founder of Subtle Medical, said, “We are using AI to improve workflow for MRI and PET exams. NVIDIA’s Clara platform will enable us to seamlessly scale our technology to reduce risks from contrast and radiation, taking imaging efficiency and safety to the next level.”
Fujifilm is also using NVIDIA’s DGX-2 supercomputer to speed up its AI-based R&D healthcare projects. The company works in pharma, biologic contract development and manufacturing organisation (CDMOs), regenerative medicine and medical equipment, including imaging.
Masataka Osaki, Japan country manager and vice president of worldwide field operations at NVIDIA, said, “Improving the accuracy and delivery of medical care is one of society’s greatest challenges.
“Combining Fujifilm’s expertise in medical imaging systems with NVIDIA’s AI leadership will supercharge the development and deployment of breakthrough applications for intelligent medical imaging systems.”

Thermo Fisher Scientific expands bioprocessing with BD acquisition


Thermo Fisher Scientific announced the acquisition of BDs Advanced Bioprocessing unit, which will join its Life Sciences Solution business.
In its latest investment into the biomanufacturing space, Thermo Fisher moved to acquire Beckon, Dickinson and Companys portfolio in the area, which includes peptones that improve cell culture media formulations.
The Advanced Bioprocessing unit has an approximate annual revenue of $100m(86.25m). It is built to provide services that improve cell culture yield while reducing variability.
A spokesperson for Thermo Fisher told us that these services will be complementary to our existing offering[s] and will add strong technical service programs.
A spokesperson for Thermo Fisher stated that the talent and expertise of the Advanced Bioprocessing teamis a key reason we are interested in acquiring the business; However, they did not confirm the numbers of staff that would be retained, stating only that such plans are just being formed.
The acquisition is expected to be completed in early 2019, for an undisclosed fee, and will add to a number of deals Thermo Fisher has made within bioprocessing as of late.
Earlier this year, the company spent $50m to bolster capacity at its St. Louis, Missouri, facility and signed a long-term contract with Juno Therapeutics to develop CAR T therapies.

Moleculin Brain Cancer Med Begins Dosing at Trial at MD Anderson


Small molecule lead drug candidate blocks a critical target for tumors and crosses the blood brain barrier; begins first brain cancer patient dosing in clinical trial at MD Anderson Cancer Center
In the ongoing challenge to combat the almost always deadly brain cancers, namely Glioblastoma and melanoma metastasized to the brain, the pharmaceutical company Moleculin Biotech, Inc., (Nasdaq: MBRX) has initiated a Phase 1 clinical trial of a new first-in-class cancer drug candidate, a small molecule compound discovered by Prof. Waldemar Priebe at  The University of Texas MD Anderson Cancer Center and known as WP1066. The compound has been shown in animal models to both inhibit an important cell signaling protein STAT3 that is involved in cell growth and proliferation and considered critical to tumor development, while also stimulating an immune response.  The first glioblastoma patient has received the initial doses of WP1066, which were apparently well tolerated, in the physician-sponsored IND (investigational new drug) study at MD Anderson Cancer Center.
Built from the chemical backbone of the active ingredient in propolis, a natural product of honey bees, WP1066 is the first anticancer agent with drug-like properties that consistently inhibits the activated form of STAT3 within cancer cells, a target that has been long-sought because of its broad range of tumor promoting effects.
Importantly, activated STAT3 supports the survival and proliferation of tumor cells, evasion of the immune response and metastasis to distant organs, as well as angiogenesis (growth of blood vessels) essential for tumor growth.  Activated STAT3 is not only connected with directly supporting tumor activity, but also suppressing the immune system, making this target even more important to cancer therapy.
With the support of extensive preclinical studies demonstrating high antitumor activity  and the critically important ability to cross the blood-brain barrier, WP1066 in this Phase 1 clinical trial will focus on treating aggressive brain tumors which all share a grim prognosis. The intent is to eventually treat up to 15 relapsed brain cancer patients over the next six to eight months. Phase 1 clinical trials typically focus on exploring safe and well tolerated doses, as well as evaluating initial signals of effectiveness. Each treatment is completed over three weeks.
“Treating the first brain tumor patient with WP1066 is the start of a very exciting and encouraging program for doctors treating the worst types of brain cancers. There has been very little progress in recent years toward improved therapies for glioblastoma and other aggressive primary or metastatic brain tumors.  WP1066 has shown extremely promising results based on animal studies where we have seen inhibition of tumor growth and improvements in survival,” said Dr. Sandra Silberman, a world-renowned oncologist and Moleculin’s Chief Medical Officer. “This is based on the fact that although STAT3 has long been identified as an important target for treating tumors, for years most efforts have focused on attempts to indirectly inhibit STAT3 from upstream signaling, not from within the cancer cell itself.  WP1066 appears to be unique in its ability in vitro and in animal models to consistently and directly inhibit the activated form of STAT3 and produce significant anticancer effects, including tumor growth inhibition and increased life span of treated animals.”
“This represents a major milestone for Moleculin,” commented Walter Klemp, Chairman and CEO.  “There has been tremendous enthusiasm within the oncology community for targeting STAT3, a key molecular hub of multiple pathways promoting tumor growth. Although the industry has been struggling to find a way to target STAT3, we at Moleculin believe that most of these efforts have been mechanistically misguided and ended in failure because their approach would ultimately be ineffective at adequately blocking the activation of STAT3 and lack the necessary drug-like properties to succeed.  The opportunity to test a unique STAT3 therapy in these patients is significant in supporting Moleculin’s mission to provide benefit for those who need new and better treatments.”

Kiniksa presents Phase 1a/1b data for KPL-716 in atopic dermatitis


Kiniksa Pharmaceuticals presented Phase 1a/1b clinical data for KPL-716, an investigational fully-human monoclonal antibody that targets oncostatin M receptor beta, at the 27th European Academy of Dermatology and Venereology Congress. In this First-in-Human clinical trial, single intravenous and subcutaneous doses of KPL-716 were well-tolerated in both adult healthy volunteers and adult subjects with moderate-to-severe atopic dermatitis experiencing moderate-to-severe pruritus, the company said. KPL-716 also demonstrated a reduction in pruritus, it added. “The results support Kiniksa’s plans for expanding clinical development into multiple chronic pruritic diseases, including prurigo nodularis,” said the company. In total, 50 healthy volunteers and 32 subjects with moderate-to-severe atopic dermatitis experiencing moderate-to-severe pruritus received a single dose of KPL-716 or placebo in the Phase 1a/1b clinical trial, with the top dose of 20 mg/kg IV in healthy volunteers and 7.5 mg/kg IV in subjects with atopic dermatitis. The mean percentage change in weekly-average Worst-Itch Numeric Rating Scale decreased by 40.4% in KPL-716 recipients compared to a 17.6% decrease in placebo recipients at Day 28 in the absence of concomitant TCS. The mean percentage change in Pruritus Visual Analog Scale decreased by 55.4% in KPL-716 recipients compared to a 10.4% decrease in placebo recipients at Day 28 in the absence of concomitant TCS. “The KPL-716 Phase 1a/1b results met a high hurdle for success, as the placebo-controlled, single-dose safety and pharmacokinetics study also demonstrated reduction in pruritus,” said John F. Paolini, MD, PhD, Chief Medical Officer of Kiniksa. “We are now considering advancement of KPL-716 into multiple chronic pruritic diseases, including prurigo nodularis. Additionally, the observed reduction in EASI scores after only a single dose of KPL-716 is encouraging. Our ongoing repeat-single-dose trial in atopic dermatitis subjects will provide longer-term exposures and data on these inflammatory disease response markers.”

Bone Therapeutics has results on Phase 1/2A delayed-union fracture therapy


All patients met primary endpoint
Optimized production process delivering critical improvements for future commercial use to be applied to all allogeneic platform clinical trials
BONE THERAPEUTICS(Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces positive final results in the Phase I/IIA delayed-union study of its allogeneic bone cell therapy product ALLOB in 21 patients, supporting the future clinical development of the delayed union indication.
The Company also announces the development of an optimized production process for ALLOB, which the Company believes delivers critical improvements in consistency, scalability, cost-effectiveness and ease of use. In order to streamline the progress of ALLOB through late stage clinical trials and towards commercialization, Bone Therapeutics intends to implement this optimized manufacturing process for all future clinical development programmes, including the Phase IIB trial of ALLOB in delayed union fractures.
The Phase I/IIA study was a six-month open-label trial to evaluate the safety and efficacy of ALLOB in the treatment of delayed-union fractures of long bones. The study evaluated 21 patients, who each had a fracture that had failed to consolidate after a minimum of three and a maximum of seven months. Each patient received a single percutaneous administration of ALLOB directly into the fracture site and completed a six-month follow-up. Fracture healing of ALLOB-treated patients was assessed using both radiological evaluation (based on CT-scan) and clinical evaluation (e.g. health status and pain).
At six months post administration, 100% of the patients met the primary endpoint, defined as an increase of at least two points on the radiological Tomographic Union Score (TUS) or an improvement of at least 25% of the clinical Global Disease Evaluation (GDE) score vs. baseline.
From a radiological perspective, the patients improved by on average 3.84 points on the TUS score (statistically significant), almost twice the required increase of two points. This minimum two-point increase was achieved by 16 out of 21 patients (76%).
From a clinical perspective, the health status of patients, as measured by the GDE score, improved statistically significantly by on average 48%. The minimum 25% improvement was achieved by 16 out of 21 patients (76%). Pain at the fracture site, an important secondary endpoint, was statistically significantly reduced by on average 61%.
Overall, ALLOB was shown to be well-tolerated and the safety profile was consistent with the interim analysis reported on 20 September 2017. As previously described in the literature covering clinical studies with allogeneic mesenchymal stem cells or their derivatives, it was observed that blood samples of about half of the patients contained donor-specific antibodies, either pre-existing or developed after administration.