Archive for the ‘Media Control’ Category

New privacy bill promises greater control for consumers, stiff fines for companies – Kamloops This Week

OTTAWA The Trudeau government is proposing new privacy measures to give people more control over their information in the digital age, with potentially stiff fines for companies that flout the rules.

The legislation tabled in the House of Commons on Tuesday is designed to flesh out the 10 principles of the federal digital charter and bring Canada's much-maligned privacy regime for businesses into the modern era.

Advocacy groups and business organizations generally applauded the bill, but there were concerns about how comprehensive the practical effects will be.

Under the legislation, companies would have to obtain consent from customers through plain language, not a long legal document, before using their personal data.

The government says the bill, the Digital Charter Implementation Act, would also give consumers the ability to more easily transfer their data from one business to another. For example, people could direct their bank to share their personal information with another financial institution.

The bill would arm the federal privacy commissioner with order-making powers, including the ability to demand that a company stop collecting data or using personal information.

In addition, the commissioner would be able to recommend that the planned Personal Information and Data Protection Tribunal impose a fine.

The legislation would provide for administrative monetary penalties of up to three per cent of global revenue or $10 million, whichever is higher, for non-compliant organizations.

It also contains harsher penalties for certain serious infractions, including a maximum fine of five per cent of global revenue, or $25 million, bringing Canada into line with Europe.

"The fines are there to provide accountability," said Innovation Minister Navdeep Bains.

"If we want Canadians to feel confident online they need to make sure that their privacy is protected, and that they have greater control over their data."

The government says the law would also ensure Canadians could demand their information on social-media platforms, such as Facebook or Twitter, be permanently deleted.

To reinforce this, the privacy commissioner would have the ability to order a social-media company to comply.

The legislation would also give the privacy commissioner powers to audit organizations, an enforcement tool that Daniel Therrien, the current commissioner, has repeatedly advocated.

The bill is a "big win for privacy in Canada," said Laura Tribe, executive director of OpenMedia, which has long pushed for stronger laws.

"For years, people have been calling on the government to increase protections for our digital privacy, to no avail," she said.

"As a result, protecting the data and privacy of Canadians has been an afterthought for many companies, knowing that there were no meaningful penalties or consequences for bad behaviour."

The group noted the legislation says consent is not required when an organization lacks a direct relationship with a person, which could water down the protections.

The bill is a step in the right direction, said Jim Balsillie, founder of the Centre for Digital Rights. "However, what seems to be missing is a clear recognition of privacy as a fundamental human right."

Goldy Hyder, president of the Business Council of Canada, said the legislative proposals set out clear rules to protect consumers, promote innovation and strengthen Canadians' confidence in the emerging digital economy.

The Canadian Internet Registration Authority, which manages .ca domains, welcomed the bill by saying trust is critical to the digital economy and central to a well-functioning internet. "Canadians must be able to trust that their personal data will be protected and not abused."

The legislation would also:

Require businesses to to be transparent about how they use automated decision-making systems like algorithms and artificial intelligence to make significant predictions, recommendations or decisions about people;

Clarify that depersonalized information, for instance through removal of a name, must be protected and that it can be used without a person's consent only under certain circumstances;

Allow businesses to disclose de-identified data to public organizations in some cases for socially beneficial purposes, such as health or environmental initiatives.

This report by The Canadian Press was first published Nov. 17, 2020.

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New privacy bill promises greater control for consumers, stiff fines for companies - Kamloops This Week

Durable Responses with ADP-A2M4 in Synovial Sarcoma with Confirmed Responses in 44% of Patients and Disease Control Rate of 94% Presented at CTOS -…

- Data support confidence in SPEARHEAD-1 as a registrational trial -

- Projected to complete recruitment of all patients in Q12021 -

- Median duration of response was 28 weeks with ongoing responses beyond 72weeks in two patients; median overall survival has not been reached

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, presented durability of response data from patients with synovial sarcoma from the Phase 1 ADP-A2M4 trial at the virtual Connective Tissue Oncology Society (CTOS) annual meeting. The oral presentation given by Dr. Brian Van Tine of the Washington University School of Medicine is available on-demand for congress attendees. Dr. Van Tine will also participate in a live stream session entitled - Immunotherapy in Sarcoma: Alveolar Soft Part Sarcoma, Clear Cell Sarcoma, Synovial Sarcoma (Proffered Papers Panel Discussion) scheduled for 9 AM EST today (November 19).

The impact on patients treated with ADP-A2M4 is transformative, as they benefit from a durable response from a single treatment. This leads to the highest quality of life I have been able to provide patients with synovial sarcoma after treatment, said Dr. Brian Van Tine, Associate Professor of Medicine, Division of Oncology, Section of Medical Oncology, Washington University School of Medicine.

Data from this trial have enabled rapid execution of our pivotal trial, SPEARHEAD-1, and support our aim to commercialize ADP-A2M4 as the first engineered TCR T-cell product in the US in 2022, said Adrian Rawcliffe, Adaptimmunes Chief Executive Officer. However, this is only the beginning of the tremendous potential of our products targeting MAGEA4. We will rapidly pursue additional indications, starting with the Phase 2 trial in gastroesophageal cancers with ADP-A2M4CD8 expected to initiate in the first half of 2021.

Data presented at CTOS were updated durability of response and safety data from the 16patients with synovial sarcoma who were treated in the Phase 1 ADP-A2M4 trial, presented earlier this year at ASCO. The data cut-off for this presentation was September 1, 2020 and results are summarized below:

About AdaptimmuneAdaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Companys unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Forward-Looking StatementsThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the SEC on November 5, 2020, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

Media Relations:

Sbastien Desprez VP, Communications and Investor RelationsT: +44 1235 430 583M: +44 7718 453 176Sebastien.Desprez@adaptimmune.com

Investor Relations:

Juli P. Miller, Ph.D. Senior Director, Investor RelationsT: +1 215 825 9310M: +1 215 460 8920Juli.Miller@adaptimmune.com

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Durable Responses with ADP-A2M4 in Synovial Sarcoma with Confirmed Responses in 44% of Patients and Disease Control Rate of 94% Presented at CTOS -...

Gesture Control Interfaces Market Overview with Detailed Analysis, Competitive landscape, Forecast to 2022 | Key Players: GestureTek, Gestigon, Leap…

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Gesture Control Interfaces Market Overview with Detailed Analysis, Competitive landscape, Forecast to 2022 | Key Players: GestureTek, Gestigon, Leap...

War of the weedkiller: why environmentalists are concerned about moves to ban Roundup – The Guardian

Glyphosate the weedkiller better known by its most-famous brand name Roundup does not have the best of public profiles.

The subject of multibillion dollar payouts over claims it causes cancer, the worlds most-popular herbicide developed by Monsanto is not known for having too many friends among environmentalists.

But away from lawsuits and petitions, there are concerns among some opponents of Australias invasive weeds that glyphosate a key tool in their armoury could be taken away from them.

Next week the Invasive Species Council will begin posting and emailing copies of a new report that looks to defend the chemical from what the council fears is a trend towards restricting its use, and even banning it entirely.

A ban on glyphosate would have serious environmental consequences, says the report, seen by Guardian Australia.

Weed invasions would increase in areas of native vegetation including national parks, and erosion would increase on farms.

A small number of Australian councils such as Georges River in south Sydney and Fairfield in the citys west have already banned glyphosate. So have several countries.

In July 2019, 500 staff at Blacktown city council walked off the job in protest at being ordered to use glyphosate. They returned when the council promised to trial alternatives.

Andrew Cox, the Invasive Species Councils chief executive, fears that the steady flow of opposition could lead to a flood.

Were worried that restrictions are being put in place across Australia without a scientific basis, he says.

We want to make sure that chemical use is safe and necessary, and we dont want to put peoples lives at risk. But we dont want to make it impossible for people to do really important weed control.

Weeds are a major threat to biodiversity and without active management to control weeds and stop them spreading, it would threaten our ecosystems.

Glyphosate is a good herbicide that has lots of benefits to weed control, particularly for environmental restoration projects and land care programs. To not have that tool available will severely hamper those efforts.

The Invasive Species Councils report is researched and written by Tim Low, an ecologist and author of seven books.

He says such was the chemicals reputation, just authoring the report was the riskiest thing I have ever written.

But he says he has become worried the chemical was being unfairly maligned in the public eye, as well as in the left-leaning media.

Lows report picks through the scientific research on the chemical, its origins, uses and its criticisms.

Low also charts the herbicides recent history, including the fallout from a 2015 declaration by the World Health Organisations International Agency for Research on Cancer (IARC) that glyphosate was a probably carcinogenic.

The decision to add glyphosate to the agencys 2A category, puts it alongside other chemicals that are probable carcinogens, but also alongside other activities in the same category such as consumption of red meat, doing night shifts, working in a hairdresser and drinking beverages hotter than 65C.

The IARCs category of known carcinogens includes alcohol, processed meat and solar radiation (sunshine).

Legitimate concerns about glyphosate, writes Low, have been exacerbated by some wildly exaggerated comments.

Low writes: Cancer is such a feared disease that many people might suppose that any cancer risk is reason to ban a chemical. But todays world abounds in carcinogens.

The governments Australian Pesticides and Veterinary Medicines Authority carried out an assessment of glyphosate after the IARC listing. About 500 products containing glyphosate are registered for use in Australia.

The agency said after the assessment it would monitor emerging science closely, but concluded there are no scientific grounds for placing glyphosate and products containing glyphosate under formal reconsideration. It said the weight of evidence showed exposure to glyphosate does not pose a carcinogenic or genotoxic risk to humans.

The agency is not alone in pushing back against the IARCs finding. A review from the United States governments EPA found there are no risks of concern to human health when glyphosate is used in accordance with its current label.

The EUs European Chemicals Agency also found no reason to classify glyphosate as a carcinogen, although it could cause eye damage and was toxic to aquatic life.

But the chemical continues to make headlines and have strong and passionate opposition, and court hearings are on the horizon.

Monsanto developed the weedkiller in the 1970s. In the 1990s, Monsanto developed genetically-modified crops that were Roundup ready and resistant to the herbicide.

In August 2018, Monsanto was ordered to pay US$289m ($397m) to a groundskeeper dying of blood cell cancer. Bayer, Monsantos owner, is appealing that case, and two others.

In June this year, the German multinational Bayer announced it would be paying almost $16bn to settle claims the firm inherited when it bought Monsanto in 2018.

Bayer chief executive Werner Baumann said at the time there was extensive scientific evidence that the companys glyphosate-based herbicide Roundup does not cause cancer and the company stood strongly behind its glyphosate-based products.

A class action is also being brought in Australia against three former and current Monsanto companies, slated for a hearing in federal court in March 2022.

Lawyers allege Roundup is carcinogenic and raises peoples risk of the blood cancer non-Hodgkin lymphoma.

Jane Bremmer, a campaigner at the National Toxics Network, said glyphosate was prolific in the environment, dangerous, and court cases around the world had shown the herbicide was carcinogenic.

I dont know how that evidence can be ignored, she says. Its an absolute delusion to suggest that you can only control weeds with poison.

Glyphosate is leaving a toxic load in our groundwater and river systems.

Bremmer is a volunteer with a group caring for a bush reserve on the Swann River on Perths outskirts without the use of chemicals. They prevent weeds growing by using organic products, covering areas to block sunlight and mechanical and hand weeding, she says.

Glyphosate and other chemicals are poorly regulated because of the power of the petrochemical industry, she says.

Peter Dixon is a board member of the Australian Association of Bush Regenerators (AABR) a group with more than 700 members promoting ecological restoration.

He says they are a pragmatic bunch of people who know their way around the differences between a hazard (like a shark) and a risk (the chance of being bitten).

We all have chemicals in our houses that can kill us, but we mitigate the risk of those hazards through knowledge and processes. Its the same with herbicides, he says.

According to Dixon, the groups members are not worried about getting cancer, but they are worried about moves to ban glyphosate.

Dixon, an environmental consultant and volunteer bush regenerator, has been part of an AABR working group on glyphosate created to try and counter misinformation over the herbicide.

On the banks of the degraded Duck River in greater Sydney, Dixon has used the herbicide for years as part of a volunteer bush care group to knock back invasive balloon vine and trad.

Bush regenerators use the herbicide as a spray and also on woody weeds where the plant is cut back and the chemical applied like paint on to the stump.

He describes glyphosate as a critical tool that can keep invasive weeds at bay on a scale that mechanical measures could not.

He says in bush regeneration, glyphosate is used not as a perennial treatment like in food production but in a way that lets native vegetation come back to the point where the chemical isnt needed any more.

Other available chemicals, he says, have not been as well studied as glyphosate and could turn out to be more toxic or less effective.

The amount of funding that goes into restoring ecosystems is tiny, says Dixon.

Its possible that without the herbicide glyphosate you would need an order of magnitude more resources to do that work.

Because of the rate of land clearing and degradation, we cant afford that luxury.

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War of the weedkiller: why environmentalists are concerned about moves to ban Roundup - The Guardian

Ziopharm Oncology Presents Encouraging Clinical Data for Controlled IL-12 for the Treatment of Glioblastoma and DIPG at the 2020 Society for…

First Data from Ongoing Phase 2 Study of Controlled IL-12 in Combination with Cemiplimab Demonstrate Promising Safety Profile in rGBM,and a Confirmed Partial Response

Updated Interim Data from Ongoing Phase 1 Study of Controlled IL-12 in Combination with Nivolumab Show a mOS of 16.9 Months in PatientsReceiving 10 mg Veledimex

First Data from Ongoing Phase 1/2 study of Controlled IL-12 Monotherapy Demonstrate Promising Safety Profile in Patient with DIPG

BOSTON, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (Ziopharm or the Company) (Nasdaq:ZIOP) today announced the presentation of new clinical data from three ongoing trials of Ad-RTS-hIL-12 plus veledimex (Controlled IL-12) for the treatment of recurrent glioblastoma (rGBM) and diffuse intrinsic pontine glioma (DIPG) at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting. Data highlights include the first discussion of interim data from the phase 2 study of Controlled IL-12 in combination with cemiplimab for the treatment of rGBM that has recently completed enrollment, updated interim data from the phase 1 study of Controlled IL-12 in combination with nivolumab for the treatment of rGBM and data from the first patient enrolled in the ongoing phase 1/2 study of Controlled IL-12 monotherapy for the treatment of DIPG.

Glioblastoma is a highly aggressive tumor and despite advances in oncology over the last few decades, median overall survival for patients with progressive GBM remains less than one year, said Rimas Lukas, M.D., Associate Professor of Neurology at Northwestern Memorial Hospital Malnati Brain Tumor Institute and investigator on the phase 2 trial of Controlled IL-12 in combination with cemiplimab. Here we report data for the first time from the ongoing phase 2 study of Controlled IL-12 in combination with PD-1 inhibitor cemiplimab, showing activation of the immune system across patients. These data are highly encouraging and underscore the potential of Controlled IL-12 to transform the treatment landscape of recurrent glioblastoma.

The updated data on combining Controlled IL-12 with nivolumab reveal a subset of patients with rGBM that demonstrate very encouraging survival at 16 months. This observation reveals that immune modulation with IL-12 and anti-PD-1 is well tolerated with an apparent survival benefit that will need further confirmation in upcoming more advanced clinical trials. These survival data in conjunction with previously reported MRIs showing partial responses is consistent with immune-mediated anti-tumor effects, noted E. Antonio Chiocca, M.D., Ph.D., study investigator, Chairman of Neurosurgery at Brigham and Women's Hospital, Professor of Neurosurgery at Harvard Medical School, and Surgical Director of the Center for Neuro-oncology at Dana-Farber Cancer Institute.

Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm, added, As we reflect on the growing body of evidence across our efforts utilizing our Controlled IL-12 platform, we are encouraged by the signs of efficacy we are seeing in these very hard-to-treat cancers. Not only are we observing cytokine production, increases in intra-tumoral T cells (cold tumors turning hot), and predictable safety after treatment with Controlled IL-12 as a monotherapy and in combination with PD-1 inhibitors, but we have reported at least one partial response in each rGBM trial we have conducted to date, for a total of six. These MRI data, along with IL-12-driven immune response complement our encouraging survival data and we look forward to future data read-outs in 2021. Further, the initial look at data from the first patient in our phase 1/2 pediatric glioma study supports Controlled IL-12s safety profile and continued development.

Controlled IL-12 in combination with PD-1 inhibitor cemiplimab is currently being examined in a phase 2 study for the treatment rGBM (NCT04006119). Preliminary data highlights shared in an on-demand presentation titled Phase 2 Trial of Controlled IL-12 in Combination with PD-1 Inhibitor in Adult Subjects with Recurrent Glioblastoma (Abstract #901183) and presented by Dr. Lukas, include:

Controlled IL-12 in combination with the PD-1 inhibitor nivolumab is currently being examined in a phase 1 study for the treatment of rGBM (NCT03636477). Interim data highlights shared in an oral on-demand presentation titled Combination of Controlled Interleukin-12 Gene Therapy with Immune Checkpoint Blockade in Recurrent Glioblastoma: Updated Results of a Multi-Institutional, Open Label Phase 1 Trial (Abstract #901050) and presented by Dr. Chiocca include:

As a follow up to our prior readout (ASCO 2020) for this combination which reported partial responses by MRI, the two patients had meaningful improvements in survival with one patient on 20 mg veledimex surviving 17.4 months (now deceased) and the other (10 mg veledimex) surviving 21.0 months (in follow up).

Controlled IL-12 monotherapy is being studied in a phase 1/2 dose escalation study (NCT03330197) for the treatment of children with gliomas, including DIPG. Data highlights from the first patient in the study shared in a poster discussion titled Phase I/II Study of Controlled IL-12 as Immunotherapy for Diffuse Intrinsic Pontine Glioma (DIPG) (Abstract #901123) and presented by Stewart Goldman, M.D., Division Head Hematology-Oncology, Neuro-Oncology & Stem Cell Transplantation at Lurie Children's Hospital and investigator in the study, include:

It is important to note that these trials, including our previously disclosed monotherapy study now consist of over 125 patients with rGBM. These provide deep learning that is ongoing and is part of the efforts to develop Controlled IL-12 as a potential therapy for brain cancers. We will continue to monitor the data across both the monotherapy and checkpoint inhibitor combination studies in the coming months. We believe there are multiple potential paths to registration for our Controlled IL-12 program, either as a monotherapy therapy or in combination with other agents, concluded Dr. Cooper.

More information about Controlled IL-12 is available on the Companys website at https://ziopharm.com/controlled-il-12/. Additionally, the presentations presented at the SNO 2020 Virtual Meeting will be available on the Companys website in the Scientific and Medical Publications section.

AboutZiopharm Oncology, Inc.Ziopharm is developing non-viral and cytokine-driven cell and gene therapies that weaponize the bodys immune system to treat the millions of people globally diagnosed with a solid tumor each year. With its multiplatform approach, Ziopharm is at the forefront of immuno-oncology with a goal to treat any type of solid tumor. Ziopharms pipeline is built for commercially scalable, cost effective T-cell receptor T-cell therapies based on its non-viralSleeping Beautygene transfer platform, a precisely controlled IL-12 gene therapy, and rapidly manufacturedSleeping Beauty-enabled CD19-specific CAR-T program. The Company has clinical and strategic partnerships with theNational Cancer Institute,The University of Texas MD Anderson Cancer Centerand others. For more information, please visitwww.ziopharm.com.

Forward-Looking Statements DisclaimerThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the Company's business and strategic plans and the progress and timing of the Company's research and development programs, including the anticipated dates for the readouts of its clinical trials and the Companys expectations regarding future enrollment in its clinical trials. Although Ziopharms management team believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Ziopharm, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, changes in our operating plans that may impact our cash expenditures, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Ziopharms product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies and for which indication; the strength and enforceability of Ziopharms intellectual property rights; and competition from other pharmaceutical and biotechnology companies as well as risk factors discussed or identified in the public filings with the Securities and Exchange Commission made by Ziopharm, including those risks and uncertainties listed in Ziopharms Quarterly Report on Form 10-Q filed by Ziopharm with the Securities and Exchange Commission. We are providing this information as of the date of this press release, and Ziopharm does not undertake any obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

Investor Relations Contacts:Adam D. Levy, PhD, MBAEVP, Investor Relations and Corporate CommunicationsT: 508.552.9255E: alevy@ziopharm.com

Chris TaylorVP, IR and Corporate CommunicationsT: 617.502.1881E: ctaylor@ziopharm.com

Media Relations Contact:LifeSci Communications:Patrick BurseyT: 646.876.4932E: pbursey@lifescicomms.com

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Ziopharm Oncology Presents Encouraging Clinical Data for Controlled IL-12 for the Treatment of Glioblastoma and DIPG at the 2020 Society for...