ProPhase Labs’ Cancer Therapeutic, Linebacker-1, pre-clinical studies with Dana Farber/Harvard Cancer Institute demonstrate impressive utility and move into next phase of testing
01 6월 2023 - 9:30PM
ProPhase Labs, Inc. (NASDAQ: PRPH) (“ProPhase”), a next generation
biotech, genomics and diagnostics company, today provided an update
regarding its progress and development strategy for Linebacker-1
(LB-1), a small molecule, multi-kinase inhibitor that is being
developed by the Company’s wholly owned subsidiary, ProPhase
BioPharma, Inc. (“PBIO”), as a potential unique therapy option for
several poor prognosis cancers.
Harvard scientists at the Dana Farber Cancer
Institute, in two separate lung and colon cancer clonogenic models,
have successfully demonstrated Linebacker’s ability to inhibit
cancer cell growth, an exciting development for the polyphenol
compound.
AH549 lung cancer cells completely lost the
ability to proliferate over a 2-week period of treatment, while the
HT29 colon cancer cells also saw significant inhibitory results. In
the AH549 model, the Linebacker monotherapy showed zero cell
proliferation, while the combination therapy showed some
proliferation, and the control group showed massive cell
proliferation. Also observed were synergies between Linebacker and
low doses of frontline chemotherapeutic agents such as Doxorubicin
in the colon cancer model. The initial observation is that
Linebacker may have enhanced utlity as a combination therapy in
cancer types that respond well or moderately well to Doxorubicin
and should also be considered as a potential monotherapy for myriad
cancers that previously showed no response.
With proof-of-principle demonstrated, the
ProPhase team is moving forward with in-depth cancer modeling to
precisely hone-in on optimal clinical pathways for development.
“We are truly excited about these ongoing
preliminary results,” said Ted Karkus CEO of ProPhase Labs.
"While the results are still early and only
in-vivo, they were better than we had initially expected,
especially looking at this as a very viable monotherapy. To date,
we have achieved excellent pre-clinical results for Linebacker as a
combination therapy. The fact that the Linebacker monotherapy
showed zero cell proliferation in lung cancer, supports our thesis
that Linebacker could make an ideal stand-alone therapy option in
lung cancer and possibly some other very hard to treat
cancers. In addition, the synergies observed between
Linebacker and low doses of frontline chemotherapeutic agents, such
as Doxorubicin in colon cancer, are exciting given the ever-popular
desire to effectively reduce doses of chemotherapies that cause
severe side effects. We are anxiously awaiting the results of the
in-vivo mouse tumor model testing as that, we believe, combined
with our upcoming toxicology studies, should set Linebacker on an
accelerated path to clinic.”
“We have a team of experts working with us on
the development of Linebacker including cancer immunologist, Dr.
Matthew Halpert, formerly of the Baylor College of Medicine, who is
working with us as a full-time consultant in collaboration with
Harvard scientists at the Dana Farber Cancer Institute, as well as
experts at Reprocell and Charles River Laboratories. We are looking
forward to Phase I human studies next year at a modest budget of
approximately $3+ million dollars for all planned studies. This is
a nominal amount given our greater than $40 million in net working
capital. At which point, with positive results and subject to the
necessary regulatory approvals, we believe we will be well situated
to explore significant licensing opportunities with major
pharma.”
Mr. Karkus concluded, “These positive
preliminary results from the Linebacker-1 studies continue to
bolster our confidence in our diversification strategy. We are
trying to develop Linebacker at minimal risk and high potential
reward within an estimated 12 – 18 months. Furthermore, the in vivo
results continue to buttress our belief that Prophase is rapidly
evolving into a multi-dimensional, diversified pharmaceutical
company with numerous very promising business lines. We are firing
on all cylinders as we develop our biotech, genomics and
diagnostics initiatives. We look forward to providing additional
updates in the coming weeks on some of our other new strategic
initiatives, some of which could be quite significant.”
About Linebacker
Linebacker is a modified polyphenol. Polyphenols
are substances found in many nuts, vegetables and berries.
Linebacker compounds are modified Myricetin, which is a common
plant-derived flavonoid. Myricetin exhibits a wide range of
activities that include strong antioxidant, anti-cancer,
anti-diabetic and anti-inflammatory activities. It displays
activities that are related to the central nervous system.
LB-1 is Mono-chlorinated Myricetin with a
Chlorine atom substituted for the Hydroxy group at 5’ (position 5
on the B-ring). LB-2 is Di-chlorinated Myricetin with Chlorine
atoms substituted for the Hydroxy groups at 5’ and 7 (position 5 on
the B-ring and position 7 on the A-ring).
About ProPhase Labs
ProPhase Labs, Inc. (Nasdaq: PRPH) (“ProPhase”)
is a next-generation biotech, genomics and diagnostics company. Our
goal is to create a healthier world with bold action and the power
of insight. We’re revolutionizing healthcare with industry-leading
Whole Genome Sequencing solutions, while developing potential game
changer diagnostics and therapeutics in the fight against cancer.
This includes a potentially life-saving cancer test focused on
early detection of esophageal cancer and potential breakthrough
cancer therapeutics with novel mechanisms of action. Our
world-class CLIA labs and cutting-edge diagnostic technology
provide wellness solutions for healthcare providers and consumers.
We develop, manufacture, and commercialize health and wellness
solutions to enable people to live their best lives. We are
committed to executional excellence, smart diversification, and a
synergistic, omni-channel approach. ProPhase Labs’ valuable
subsidiaries, their synergies, and significant growth underscore
our multi-billion-dollar potential.
Forward Looking Statements
Except for the historical information contained
herein, this document contains forward looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements regarding our strategy, plans,
objectives and initiatives and projected timelines for our
preclinical and clinical programs and commercialization. Management
believes that these forward-looking statements are reasonable as
and when made. However, such forward-looking statements involve
known and unknown risks, uncertainties, and other factors that may
cause actual results to differ materially from those projected in
the forward-looking statements. These risks and uncertainties
include but are not limited to our ability to obtain and maintain
necessary regulatory approvals, general economic conditions,
consumer demand for our products and services, challenges relating
to entering and growing new business lines, the competitive
environment, and the risk factors listed from time to time in our
Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and any
other SEC filings. The Company undertakes no obligation to update
forward-looking statements except as required by applicable
securities laws. Readers are cautioned that forward-looking
statements are not guarantees of future performance and are
cautioned not to place undue reliance on any forward-looking
statements.
For more information, visit
www.ProPhaseLabs.com
Media Relations and Institutional
Investor Contact: ProPhase Labs, Inc.
267-880-1111investorrelations@prophaselabs.com
Retail Investor Relations
Contact:Renmark Financial CommunicationsJohn
Boidman514-939-3989Jboidman@renmarkfinancial.com
Source: ProPhase Labs, Inc.
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ProPhase Labs (NASDAQ:PRPH)
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