Bold Therapeutics Successfully Initiates Clinical Trial of First-in-Class Anti-Cancer Agent BOLD-100
Oct 8, 2020
VANCOUVER, BC, Oct. 9, 2020 /PRNewswire/ -- Bold Therapeutics, a clinical-stage biopharmaceutical company, announced that the first patient for the company's Phase 1b oncology clinical trial has been enrolled at the Cross Cancer Institute (Edmonton, Alberta) under Principal Investigator Dr. Jennifer Spratlin. This trial investigates the safety and tolerability of Bold Therapeutics' first-in-class anti-cancer agent, BOLD-100, in combination with the current standard-of-care, FOLFOX (5-fluorouracil, leucovorin, oxaliplatin), for the treatment of patients with advanced gastric, pancreatic, colorectal and bile duct cancers. Five additional hospitals across Canada will also be enrolling patients: Princess Margaret Cancer Centre in Toronto, Ontario (PI Grainne O'Kane); Ottawa General Hospital in Ottawa, Ontario (PI Rachel Goodwin); Juravinski Cancer Centre in Hamilton, Ontario (PI Elaine McWhirter); and Jewish General Hospital and Royal Victoria Hospital in Montreal, Quebec (PIs Petr Kavan and Jamil Asselah, respectively).
Bold Therapeutics Successfully Initiates Clinical Trial of First-in-Class Anti-Cancer Agent BOLD-100
BOLD-100 is a first-in-class ruthenium-based therapeutic that selectively inhibits stress-induced upregulation of GRP78 and alters the unfolded protein response (UPR), mitigating resistance, survival and proliferation, with additional synergistic direct anti-cancer activity.
"Bold Therapeutics has achieved another key clinical development milestone. The current trial will provide data on not only the safety and tolerability of BOLD-100 in combination with FOLFOX, but also important efficacy measures to evaluate patient outcomes," stated Jim Pankovich, EVP of Clinical Development. "Bold Therapeutics is working with an experienced team of investigators across Canada – and, later, in the United States and South Korea – for this groundbreaking clinical trial. The dose-escalation portion of this adaptive-design study will enroll approximately 12 patients in cohorts of three after which the expansion-cohort portion will enroll up to 80 patients, with 20 patients in each arm."
In a previously completed 46-patient Phase 1 monotherapy study, BOLD-100 was well-tolerated with minimal hematological and neurological side effects, suggesting it could be combined favorably with other anti-cancer therapies. Preclinical data shows profound synergy in combination with numerous drug classes ranging from traditional chemotherapies to newer targeted therapies and immune-oncology agents. The company received a No Objection Letter (NOL) from Health Canada earlier this year and has an open Investigational New Drug (IND) and an Orphan Drug Designation (ODD) in pancreatic cancer in the United States, with additional ODDs expected over the next six months.
"Cancer drug resistance remains a significant challenge for patients and physicians. We have deliberately chosen some of the most difficult-to-treat indications with the shortest mean survival times for this trial because this is where there is the greatest unmet medical need," said E. Russell McAllister, CEO. "Preclinically, BOLD-100 significantly improves outcomes in a wide range of different indications and combinations, acting through both anti-resistance but also direct anti-cancer pathways. We are now actively evaluating additional development options, some in partnership with other pharmaceutical companies, and we expect to initiate at least one additional oncology clinical trial in 2021. Areas of particular interest include triple-negative breast cancer; neoadjuvant therapy; first-line combinations with immuno-oncology agents; sarcomas; and various liquid tumors, including multiple myeloma – all of which are potentially viable development indications and combinations based on preclinical data and/or relevant literature."
Additional information on this study is available at www.clinicaltrials.gov/ct2/show/NCT04421820.
For more information, please visit the Company's website at www.bold-therapeutics.com
Contact:
E. Russell McAllister, CEO
(604) 262-9899
[email protected]
SOURCE Bold Therapeutics Inc.
Related Links
More News
Why CJP's Saurav Das, Ashutosh Ranka have been sent to Tihar jail for 5 days: Cockroach Janta party founders Jantar Mantar arrest case explained
Saurav Das, Ashutosh Ranka Jail Reason: CJP leaders Saurav Das and Ashutosh Ranka have been sent to five days of judicial custody after Delhi Police detained them over their alleged entry into Jantar Mantar, which has been de-notified as a protest site. The action came days after their release on a one-year peace bond. Another CJP functionary, Ajinkya Shinde, has reportedly been released.
US Judge extends order blocking Trump from banning CNN, MS NOW, Politico reporters from White House
A US federal judge has extended an order preventing the Trump administration from banning certain reporters from the White House. US District Judge Timothy Kelly ruled that CNN, MS NOW, and Politico have strong constitutional claims. The judge emphasized that concerns regarding the media's accuracy and fairness are valid. He ordered the restoration of the reporters' press credentials while the case continues.
Makhi Janta Party gains 3.4 lakh followers after Chief Justice of India said 'hammer to kill a fly'; MJP wants to partner with CJP
Makhi Janta Party: A satirical page called Makhi Janta Party has taken its name from Chief Justice of India Surya Kant’s “hammer to kill a fly” remark in Supreme Court. It gains more than 3.4 lakh followers on Instagram within 72 hours, backs protester Neha Bora and says it wants to explore a common stand with Cockroach Janta Party.
Think Tank flags security concerns over Starlink, advocates protectionist approach by India
Elon Musk's Starlink is under debate in India regarding its potential geopolitical influence and technological implications. The Kutniti Foundation's report warns that Starlink could undermine India's technological sovereignty and harm its New Space industry. Starlink is said to bypass local regulations to establish unregulated connections with users. India's Ministry of Communications has denied claims about blocking Starlink's licenses due to vested interests.
Think Tank flags security concerns over Starlink, advocates protectionist approach by India
Elon Musk's Starlink is under debate in India regarding its potential geopolitical influence and technological implications. The Kutniti Foundation's report warns that Starlink could undermine India's technological sovereignty and harm its New Space industry. Starlink is said to bypass local regulations to establish unregulated connections with users. India's Ministry of Communications has denied claims about blocking Starlink's licenses due to vested interests.
Court orders 5-day judicial custody to CJP’s Saurav Das, Ashutosh Ranka
Delhi Police placed three leaders of the Cockroach Janata Party into preventive custody on Wednesday morning. Saurav Das, Ashutosh Ranka, and Ajinkya Shinde were detained after attempting to enter Jantar Mantar. A case was registered against them for trespassing and obstructing public officials, among other charges. CJP leader Ratna Singh claimed the detained leaders were denied access to their lawyers initially.
Court orders 5-day judicial custody to CJP’s Saurav Das, Ashutosh Ranka
Delhi Police placed three leaders of the Cockroach Janata Party into preventive custody on Wednesday morning. Saurav Das, Ashutosh Ranka, and Ajinkya Shinde were detained after attempting to enter Jantar Mantar. A case was registered against them for trespassing and obstructing public officials, among other charges. CJP leader Ratna Singh claimed the detained leaders were denied access to their lawyers initially.
Honda CB250SS Scrambler Concept: Price, engine, mileage, weight, bookings and India launch details
Honda CB250SS Scrambler Concept features a 249cc liquid-cooled engine, retro styling, upside-down front forks and a TFT display. Check its expected price, engine specs, mileage, weight, booking date, sale date and India launch status.
YOUR NEWS, OUR NETWORK.
Do you have Great News you want to tell the world?
Be it updates about your business or your community, you can make sure that it’s heard by submitting your story to our network reaching hundreds of news sites across 6 verticals.