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Phase 1 clinical trials are designed to test the safety and tolerance of the treatment. This is the fastest advance to the fourth dosage cohort for a cancer treatment that I have ever seen.
In order to escalate the dose, an independent safety committee must review detailed data about the effect of the treatment on the subjects. As a secondary measure, the effect of the treatment on the cancer will also be monitored.
The P53 gene mutation associated with these gynecological cancers is also seen in many other cancers. If proven safe and effective in this trial, COTI-2 will very likely be rapidly tested in other cancers exhibiting the P53 oncogenetic mutation.
Lar
Independent Dose Escalation Committee recommends continuing the study at an increased dosage
LONDON, ON and BOSTON, MA--(Marketwired - January 10, 2017) - Critical Outcome Technologies Inc. ("COTI" or the "Company") (TSX VENTURE: COT) (OTCQB: COTQF), a clinical stage biotechnology company advancing a pipeline of targeted therapies for the treatment of cancer, announced today that the Company has commenced dosing women in the fourth cohort of its ongoing Phase 1 clinical trial of COTI-2 intended for the treatment of gynecological cancers. The objective of the fourth cohort is to continue to evaluate the safety and tolerability of COTI-2.
"We are pleased to report that the first two patients in cohort 4 have begun receiving COTI-2 at a dosage level of 1.7 mg/kg, an increase from the 1.0 mg/kg level of cohort 3. We are further pleased to report that there were no significant adverse events attributed to treatment in any of the cohort 3 patients," said Alison Silva, COTI's President & CEO. "Preliminary clinical data is consistent with the low toxicity profile observed during preclinical studies. Accordingly, the independent Dose Escalation Committee granted a favourable opinion to move ahead with the fourth cohort of patients. We are pleased with the Committee's recommendation and trial advancement to date."
More information about COTI-2 and the ongoing clinical study is available on the Company website: http://criticaloutcome.com/coti-2.
About Critical Outcome Technologies Inc.
COTI is a clinical stage biotechnology company advancing innovative and targeted therapies for the treatment of cancer. The Company's lead compound, COTI‐2, has a novel p53‐targeting mechanism of action with selective and potent anti‐cancer activity. A potential breakthrough treatment for many types of human cancers, COTI-2 is a potent small molecule activator of misfolded mutant p53 proteins. COTI‐2 is being initially evaluated for the treatment of gynecologic cancers, which includes ovarian, cervical, and endometrial cancers in a Phase 1 clinical trial at the MD Anderson Cancer Center at the University of Texas and the Lurie Cancer Center at Northwestern University. The Company has secured orphan drug status in the U.S. for COTI‐2 for the treatment of ovarian cancer in patients failing first line therapies and is planning additional studies in other cancer indications. These studies are supported by more than ten animal xenograft models showing both single and combination agent activity of COTI‐2 with other leading cancer drugs. Preclinical data provides evidence to suggest a potentially dramatic change in the treatment of cancers with mutations of the p53 gene. The Company is also advancing COTI‐219, a novel oral small molecule compound targeting the mutant forms of KRAS and discovered using the Company's proprietary drug discovery technology platform, CHEMSAS®. KRAS is a highly desirable drug target as these mutations are detected in up to one‐quarter of all human cancers, particularly lung, colorectal, pancreatic, and thyroid cancers and represents a tremendous unmet clinical need. An IND for evaluating COTI-219 in clinical trials in the U.S. is expected in late 2017. COTI-2 and COTI-219 represent significant opportunities to target two fundamental and central pathways responsible for the development of multiple cancers. COTI‐2 and COTI‐219 each have the potential to either independently or in combination with other therapies, dramatically improve the outcome for many people with cancer.
Follow on Twitter @CriticalOutcome.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For more information, visit www.criticaloutcome.com.
Notice to Readers
Information contained in this press release may contain certain statements, which constitute "forward-looking statements" as such term is defined under applicable securities laws. For example, the statements, "An IND for evaluating COTI-219 in clinical trials in the U.S. is expected in late 2017" and "COTI‐2 and COTI‐219 each have the potential to either independently or in combination with other therapies, dramatically improve the outcome for many people with cancer" are forward-looking statements. Forward‐looking statements by their nature are not guarantees of future performance and are based upon management's current expectations, estimates, projections and assumptions. COTI operates in a highly competitive environment that involves significant risks and uncertainties, which could cause actual results to differ materially from those anticipated in these forward‐looking statements. Management of COTI considers the assumptions on which these forward‐looking statements are based to be reasonable, but as a result of the many risk factors, cautions the reader that actual results could differ materially from those expressed or implied in these forward-looking statements. Information in this press release should be considered accurate only as of the date of the release and may be superseded by more recent information disclosed in later press releases, filings with the securities regulatory authorities or otherwise.
The truce agreement required that, amongst other things, hub leaders ensure that the subject matter here was solely about Zenyatta Ventures, and that violations of the six rules were properly dealt with.
There are dozens of violations filed here that have not been dealt with, over a period of months.
The current discussion about other companies is inappropriate.
If hubleaders do not properly process all outstanding violations within 48 hours (each one triggers an email notification), I will consider the truce to be null and void.
Remember what Schwarzenegger said.
Lar
Thanks for bringing this company and the Windfall project into the limelight again, luker.
Based on what I've reviewed of the company's filings, they will indeed do 250,000 metres of diamond drilling at Windfall. And, they can certainly afford it. As at September 30, they had more than $80million in the treasury.
Lar
I've got a couple presentations from circa 2011/2012. Is that what you're looking for?
Here's a link to one from 2012. https://web.archive.org/web/20120623080141/http://www.norontresources.com/Investors/getDocument/2012corporatepresentation-v4.pdf/193
Lar
The System for Electronic Disclosure by Insiders (SEDI) is the official source for all of the commercial insider reporting services such as Canadian Insider and INK. The reason they even exist is that SEDI is not an intuitive website to learn how to use. If you want to find out the formal public insider disclosure, SEDI is it. I find numerous mistakes in other services.
To access the public disclosure, first, go to sedi.ca I'm English speaking, please select the English option.
A new page opens. At the top right, in the grey area, clink on "Access public filings"
A new window opens. In the orange, on the left, select "View summary reports"
Select the "Insider transaction detail" radio button, and hit Next at the bottom of the page
This new screen is the workhouse for anything you want to know. You can search by a person's name, or any public company (here, called an issuer). You can save a link to this page, and skip the earlier steps, too.
So, with this page filled out, you can search in two ways, by a an individual's name, or by e.g Noront summary filings.
Let's go with Noront for the moment, and fill out the form accordingly.
In the first drop down menu, top left, select issuer name. In the box to the right of that, type in Noront.
The next row of drop down menu items lets you restrict the date range. If you're only looking for recent filings, it can save a lot of space in the final report you generate if you restrict the time window.
On the left, I always select Date of filing from the drop down menu, and input today's date as the end of the search period. That searches everything in the public record up to the moment you retrieve a report, and you don't need to know the dat of transaction to learn what's going on. To cover the recent filing history of all Company insiders, let's use January 1, 2016 as our start date, and today's date as the end date. (that searches what's in SEDi right up to the moment you hit the search button, as I said)
Scrolling down the page, you'll see a large number of check boxes. They've simplified it by giving you the gray boxes in the left column. You want to know Equity (includes common shares) and you want to know Issuer Derivatives (options and warrants), so just click on those two, and you'll see all the boxes in those categories get checked off.
Scroll to the bottom and hit search, and voila, you get one result. Click view (in tiny blue letters, I know) and it will open the complete record that matches your search criteria. You can download it as a pdf, or refine your criteria if the results aren't what you were looking for. If you click on the "Refine Search Criteria" you go back to that form we filled out, so you can change whatever needs changing and try again. If I see that the Exchange has reported marker trades, I'll fill out the form and update it over and over again by refining my search criteria to see if the marker was real. Canadian Insider or whatever update overnight, so if you're searching SEDI during the business day, you might see insider trades that others don't know about yet.
If you search by name, you have to know the name of the reporting insider precisely. If you don't know that yet, a company search will show you the name they report under.
If you have any questions or concerns, just let me know. It just takes some getting used to. But SEDI is the official record, so it's worth it.
Regards,
Lar