AVM Biotechnology Announces Full Enrollment of First Cohort of Relapsed/Refractory Non-Hodgkin's Lymphoma Patients Dosed with AVM0703 at major Cancer Centers in USA
SEATTLE, April 7, 2021 /PRNewswire/ -- AVM Biotechnology announced today that the first cohort has been fully enrolled in their clinical study (NCT04329728 "The WWRD Study"). All three patients had failed multiple prior therapies, and one had failed two transplants. These patients are reportedly all doing very well, and one was quoted as saying, "I feel great!" Three major US Cancer Centers are actively enrolling study participants. AVM Biotechnology is excited to advance AVM0703 to the next dose level cohort of no-option lymphoma patients. The drug has been well tolerated, without safety issues, as expected. The study is an adaptive design/expansion cohort trial such that cohort enrollment of relapsed/refractory Non-Hodgkin's Lymphoma patients for the pivotal trial can immediately follow the dose-escalation phase.
Since originally approving the study, the FDA has approved a reduction in the interval between patients in a cohort, from 7 days to 48-hours and between cohorts, from 21 to 7 days of dosing for the first two cohorts. This reduction was approved in response to drug tolerance data submitted from patients treated under FDA approved compassionate use applications.
"Considering the delay of many clinical studies due to the pandemic, we are gratified to see enrollment occurring so rapidly," said Janet R. Rea, AVM COO. "We are pleased to see these patients tolerate the drug well after failing multiple other therapies and look forward to seeing continued positive results with dose escalation."
The administration of a single dose of AVM0703 is believed to activate the innate immune system to launch novel gamma/delta Natural Killer T cells (NKT cells), and cytotoxic T cells that possess enhanced activity. Once triggered, these cells provide rapid onset of action and response. AVM0703 targets lymphoma while sparing normal lymphocytes, platelets, red blood cells, and stem cells. AVM believes this treatment could reduce the need for transfusions, lower the costs of cancer care associated with managing treatment side-effects, and improve quality of life for lymphoma patients.
"AVM0703 represents an entirely new approach for cancer and non-cancerous diseases. It has the potential to be a true game-changer. I am encouraged by the pre-clinical data and look forward to seeing results of this pivotal trial," said Dr. William Matsui, MD, Deputy Director of Livestrong Cancer Institute.
AVM0703 is available under Expanded Access or Compassionate Use guidelines.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma, a broad heterogeneous constellation of lymphoproliferative disorders, is the seventh most common cancer in both men and women, affecting an estimated 77,240 people in the US each year. The overall five-year survival rate is approximately 72%, and over half of the newly–diagnosed cases are in people over age 65 years. Remission following initial established treatment is common, but the disease typically recurs or relapses in as many as 50% of the patients within two years,1 and in some patients, their disease is "refractory," or resistant to additional treatment. Second-line or so-called salvage therapy in these patients consists of stronger chemotherapy "cocktails" or, more recently, cell therapy or hematopoietic cell transplantation. Both approaches can have significant and serious side effects, and the response rates to salvage chemotherapy range from 26%2 to 45%3, with 50% of patients proceeding to autologous stem cell transplant (ASCT). Four-year survival rates are less than 40% utilizing salvage chemotherapy and 60% for those who then undergo ASCT.3 Treatments and associated side effects, coupled with the medical fragility associated with these patients, leaves many of them no treatment options, i.e., "no-option". AVM Biotechnology is committed to providing an option to these patients.
For information on AVM Biotechnology, LLC., contact
Jena Dalpez
Director of Communications & Public Relations
1749 Dexter Avenue North
Seattle WA 98034
[email protected]
+1 206-906-9922
This contains certain statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not relate strictly to historical or current facts and they may be accompanied by words such as "could," "would," "may," "potentially," "suggest," "believes," "expects," "should," and similar words or expressions. These forward-looking statements reflect our current views as of the date this is published, and are subject to risks, uncertainties, assumptions, changes in circumstances, and other factors; drug development and commercialization are highly risky and early clinical results in animals or humans may not reflect the full results from later stage or larger scale clinical trials. These forward-looking statements are subject to risks and uncertainties that could cause our actual results, performance, and expectations to differ materially from those expressed or implied by these statements, including statements about: future and ongoing drug development and timing; the applications of drugs to specific diseases; the potential for ongoing preclinical or clinical trial results; FDA or other regulatory findings and approvals; potential market opportunities; and the occurrence of future events or circumstances. There are risks and uncertainties involving and not limited to our ability to progress in our research and development efforts, complete clinical testing, achieve our expected results, commercialize our products, avoid infringement of patients, trademarks and other proprietary rights of third parties, protect products from competition, navigate the political environment, maintain sufficient capital and funding, avoid problems with our manufacturing processes, maintain our operations, and obtain regulatory approval to sell and market the drugs in the United States and elsewhere. The reader should not place any undue reliance on such forward-looking statements. We have no obligation to release publicly the results of any revisions to any of our forward-looking statements to reflect events or circumstances after the date these statements are made or to reflect the occurrence of unanticipated events, except as may be required by law.
Notes to Editors
- Chao MP, Treatment challenges in the management of relapsed or refractory non-Hodgkin's lymphoma – novel and emerging therapies. Cancer Manag Res. 2013;5: 251–269.
- Crump M, Neelapu S, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800-1808.
- Kuruvilla J, MacDonald D, Kouroukis, C, et al. Salvage chemotherapy and autologous stem cell transplantation for transformed indolent lymphoma: a subset analysis of NCIC CTG LY12. Blood. 2015;126(6):733-738.
SOURCE AVM Biotechnology, LLC
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