Ch 3 - Experiment 007

Institute of Temporal Physics (ITP)
Temporal Analysis Particle Accelerator (TAPA) Experimental Log

SEPTEMBER 23, 2015 - Peak Energy 9.8TeV Entanglement Resonance Receiver Test

...

11:24pm - Dr. Ridley extracts containment vessel, reports transmission received. Experiment cycle identifiers Zero-Zero-One through Zero-Zero-Seven are present and recorded.

Reminder: Cycle identifier Zero-Zero-Eight to be transmitted at 8:32:16pm Apr 06, 2024.

11:49pm - Containment vessel recovered, contents are as follows.

Signed: Matthew Cendric, Alexandra Ridley

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Experimental Package Item 004-A

Matthew Cendric, physicist and researcher, dies at 37

FEB 15, 2016

            Waterloo physicist and leading researcher at the Institute of Temporal Physics, Matthew Cendric, PhD, died February 13th after a short battle with lung cancer. He was 37.

            Cendric was dedicated to his life's work, working alongside his fellow researchers until the final weeks of his life. "The work was everything to him, he believed that what he was doing would change the world. And when you are there working with him, seeing his passion for what he was doing, you couldn't help be believe right along with him." said Riya Sastri, PhD, and junior researcher at ITP. Cendric had reportedly been offered a promotion to Institute Director on more than one occasion, but had refused each offer in order to continue to concentrate on his scientific work.

            In a February 14 Facebook post, Alia Cendric-Lee, Cendric's sister wrote "Yesterday my brother Matthew passed away, only a few short months after being diagnosed with lung cancer that has spread to his brain. My brilliant and baffling brother. His head was forever in the clouds, seeing further than other men could see, but his heart was always at home. He was a good husband and father, and we will forever miss you. اللهم اغفر له".

            Cendric was born in North York to immigrant parents, a Kurdish father and an Iranian mother who arrived from Turkey in 1977. He obtained his bachelor of Science in Physics at the University of Toronto in 1996 before travelling to England to study under the tutelage world-renowned physicist Stephen Hawking at the University of Cambridge's Department of Applied Mathematics and Theoretical Physics. He received his MSc with First-class honours in 1998 and graduated with a PhD in 2001. At Cambridge, he also met classmate Cheryl MacIver, whom he married in 1999.

            During the summer of 2001 the two welcomed the birth of their first child, Jacob. In November of that year, Cendric returned to Canada with his wife and newborn son in tow amid the rapidly worsening political climate following the attacks in New York as well as a series of bombing attacks earlier in the year by the Real IRA, accepting a research position at the University of Waterloo. In the following years he authored 12 scientific publications before accepting a research position at the newly founded Institute of Temporal Physics in 2004. In 2005 they welcomed a second child, Mary, and then in 2008 a third, Fiona.

Cancer diagnosis

            In September of 2015, just prior to one of Cendric's most important experiments and the culmination of eleven years of research, he collapsed suddenly. In October 2015, Cendric, who had never smoked, was diagnosed with stage-4 non-small-cell EGFR-positive lung cancer that had metastasized to the brain. "In retrospect" he wrote in January 2016 "I had been living with chronic headaches for some time, I had lost much of my appetite and had dropped close to 20 pounds, and had a lingering cough since the spring. The signs were there, but with the stress of the work I was doing and the long hours I was putting in, I had written them off as overwork and lack of sleep. It wasn't until my doctor recommended a CT scan after I fainted and hit my head that I thought there could be something wrong."

            Despite being given a poor prognosis, his first reaction was a positive one. "He accepted the likelihood that he would die soon and it seemed to almost relax him. After the difficulty of the previous year, he seemed to take the news with relief."

Continuing to work

            After his diagnosis he spent many hours researching cancer, how it spread, and reading up on new studies on ways to combat it. "He was very open about his disease." said PhD student Paul Grandy "He would talk about it to anyone who would listen, and spent hours talking to doctors and technicians about treatments, and studies, and how he could best contribute, as a subject, to the field of cancer research."

            "He was an inspiration to us all." said Dr. Alexandra Ridley, a fellow leading researcher at ITP. "He had a fierce, driving energy in him that was most obvious when he was feeling his worst, a determination to ensure that something of value would be taken from his experience. That in the future others would reap the benefit."

            Cendric is survived by his wife, Cheryl Eloise Cendric, CA, CPA, a financial advisor at Sun Life Financial; son, Jacob and daughters, Mary and Fiona; parents, Warhêl and Fatima; sister Alia Cendric-Lee; and Alia's wife Emily Cendric-Lee and their children Sophie and Zoe.

            Cendric has chosen to donate his body to cancer research, and a memorial service will take place at 2 p.m. February 16 at the Waterloo Masjid at 213 Erb St W. (Those attending the memorial are advised to arrive before 1:30 p.m. to allow plenty of time for parking.)

            The family has asked that donations be made to the Canadian Cancer Society in Cendric's memory in lieu of gifts or flowers.

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Experimental Package Item 007-A

Phase IIB/III IG-11820 Immunotherapy Study in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)

Summary

            This is a Phase IIb/III randomized, double-blind placebo-controlled study to assess overall survival and to compare the efficacy and safety of first-line therapy combined with Immugene immunotherapy IG-11820, Cisplatin + Bevacizumab/Avastin, or placebo in stage IIIB/IV non-small cell lung cancer (NSCLC).

            IG-11820 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coded sequences for mouse MUG1 into cultured human lung cancer cell lines. IG-11820 is intended to provoke a strong immune system response in the patient, and to stimulate identification of cancer cells based on the shared abnormalities between IG-11820 and the patient's own cancer cells. The presence of foreign genetic material is intended to generate a hyperacute rejection of the patient's cancerous tumor.

Eligibility Criteria

Inclusion Criteria:

  • Newly diagnosed and confirmed Stage IIIB/IV non-squamous non-small cell lung cancer [NSCLC]
  • No more than 4 brain metastases, each ≤3 cm in size
  • No evidence of cerebral edema
  • Male or female at least 18 years of age and life expectancy of at least 3 months
  • Male and female patients must agree to use at least one highly effective contraception or two effective contraceptive methods during the study period and for 3 months after the last treatment administration
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Bilirubin (total) ≤1.5 x ULN
  • Glomerular filtration rate ≥ 60 mL/min (according to modification of diet in renal disease [MDRD] formula or cockroft-gault formula)
  • Lymphocytes count (total) ≥ 0.5x10E9/L
  • Neutrophils ≥ 1.5x109/L
  • Platelets count ≥ 100x10E9/L
  • Serum alkaline phosphatase ≤ 2x ULN
  • Serum transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) ≤ 1.5 x ULN
  • White blood cells ≥ 3.0x10E9/L including hemoglobin ≥ 10.0 g/dL

Exclusion Criteria:

  • Pregnancy or lactation
  • Squamous carcinoma, or having presented a serious hemorrhage or recent hemoptysis
  • Subjects with liver or bone metastases, spinal cord compression, or intractable back pain due to compressive or destructive mass
  • Active or history of a known autoimmune disease
  • Subjects under chronic treatment with systemic corticoids or other immunosuppressive drugs (eg. cyclosporine)
  • Subjects who require emergent use of system steroids
  • Known allergy to eggs, gentamicin, or platinum-containing compounds

Trial Details

Trial Status: Recruiting
Start Date: December, 2013
Expected Enrolment: 1024
Type of Trial: Treatment
Protocol IDs: NCT02857382, CA381-013
Trial Phase: Phase IIB/III
Medical Conditions: Non-squamous Non-small Cell Lung Cancer
Drugs: Cisplatin, Bevacizumab/Avastin
Lead Sponsor: Immugene Inc.
Type of Treatment: Biological: IG-11820
Principal Investigator(s): Patricia Castillo, MD
Date Posted: September 16, 2013
Last Updated: October 3, 201

Centres / Contacts

The Ottawa Hospital
Patricia Castillo, MD
501 Smyth Road, Ottawa ON, K1H 8L6
613-737-770

Princess Margaret Cancer Centre - Toronto ON
Randall Winsome, MD
610 University Avenue, Toronto ON, M5G 2M9
416-946-200

Hamilton Health Sciences - Hamilton ON
Jane Darby, MD
699 Concession St, Hamilton ON, L8V 5C2
905-387-949

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Experimental Package Item 007-B

Immugene Announces Publication of Phase IIB/III Immunotherapy Study Results for Treatment of Non-squamous NSCLC

            Ottawa, ON -- July 14, 2021 -- Immugene Inc. announced positive results today from the Phase IIB/III CA381-013 study of Ignerovax® showing clinically meaningful reduction in cancerous cells in non-squamous non-small cell lung cancer patients. The data is being published in the July 2021 issue of Cancer Research.

            "Lung cancer is one of the deadliest and most common cancers, and one that has long resisted improvements in treatment and survivability over time. With these results we are seeing the first significant strides forward in improving the quality of treatments for lung cancer." said Patricia Castillo, Ph.D., director of the Ottawa Hospital lung cancer program. "Immunotherapy works much in the way of vaccines by training the body's immune system to recognize cancer cells as invaders by using foreign genetic material that it recognizes bonded with cancer cells and triggers a strong immune response that will attack cancer cells throughout the body."

About Non-Small Cell Lung Cancer (NSCLC)

            Non-small cell lung cancer is the most common type of lung cancer. The three primary types of NSCLC are squamous cell carcinoma which is often linked to a history of smoking, adenocarcinoma which is the most common type of lung cancer found in non-smokers and younger people, and large cell carcinoma which grows and spreads quickly. Each year sees more than 1.35 million cases worldwide each year and accounts for 11% of total cancer diagnoses. It is the leading cause of cancer death worldwide in both men and women. About 60% of patients are first diagnosed with advanced NSCLC, meaning it has already spread beyond the lung. Median survival for all Stage IV NSCLC patients is 4 months from diagnosis and the 1-year and 5-year survival rates are 18.4% and 1.9% respectively.

About Ignerovax

            Ignerovax® was recently granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of non-squamous NSCLC. This designation was intended to expedite the approval of drugs intended to treat serious diseases that demonstrate substantial improvement over existing therapies.

            CA381-013 (NCT02857382) is a Phase IIb/III multicenter study evaluating the efficacy and effectiveness of Ignerovax® over current phase 1 treatments and a placebo in conjunction with radiation therapy. The main study cohort included 1,024 patients of which 362 were assigned to the primary trial group, 347 to a group receiving a combination of Cisplatin + Bevacizumab/Avastin, and 315 to a placebo group. At the conclusion of the study showed a significant improvement in Median survival, as well as 1-year and 5-year survival rates over both the current standard for treatment and the control group.

  Ignerovax Current Standard Control
Median Survival 11 months 4 months 3 months
1-year Survival 43.1% 19.0% 14.0%
5-year Survival 4.1% 2.0% 1.3%

About Immugene

            Founded in 2009, Immugene is a leading oncology-focused biotech company based in Ottawa ON.

Posted: July 2021

A 12 page summary of detailed study results are attached to the press release.

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Experimental Package Item 007-C

The following is hastily written on a scrap of paper and tucked within the pages of the summary of detailed study results

Marius Pelkey, Age 52
Princess Margaret Cancer Centre Rm 613
Enrolled Oct 22, 2015
Group 1 ID IG11820-C164
61 Johnston Ave, Toronto
Died Nov 14, 2015 - cerebral hemorrhage
caused by aneurysm, unrelated to treatment

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Experimental Package Item 007-D

Phase IIB/III IG-11820 Immunotherapy Study in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
Patient Outcome Report

Study identifier: NCT02857382, CA381-013
Patient identifier: IG11820-B152
Initial diagnosis: Stage IV NSCLC Undifferentiated Carcinoma T2N1M1b with two brain metastases ≤ 3cm in size
Date of diagnosis: Oct 13, 2015
Study enrollment date: Oct 19, 2015

Patient-Reported Outcomes Measurements (PROMs) using FACIT Measurement System

FACT-G (Ver4) (27 questions, score 0-108)
FACT-Br (Ver4) (23 questions, score 0-92)
FACT-L (Vr4) (9 questions, score 0-36)
Week 0: 85 (26/25/12/21), 86, 34
Week 4: 81 (23/25/13/20), 79, 32
Week 8: 76 (20/24/12/20), 67, 29
Week 12: 58 (14/22/9/13), 48, 23
Week 16: 31 (5/19/4/3), 12, 8

Clinical Outcome

Treatment halted, final cycle completed Feb 9, 2015. Patient died after 16 weeks +4 days due to primary effects of brain metastases.

Patient Group

During this study, patient was assigned to Group III (control).

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