Cellceutix Plans for Future Trials Aimed at the La
Post# of 72440
Posted On: 03/08/2013 4:55:05 PM
Cellceutix Plans for Future Trials Aimed at the Latest Initiatives of ‘Breakthrough’ Designation by the Food and Drug Administration
Cellceutix Conducts Research on Retinoblastoma Cancer
Beverly, MA - Cellceutix Corporation (OTCBB: CTIX) (the
"Company"), a clinical stage biopharmaceutical company
focused on discovering small molecule drugs to treat unmet
medical conditions, including drug-resistant cancers and
autoimmune diseases, is pleased to report that Kevetrin™,
the Company’s lead anti-cancer compound currently in a
Phase 1 clinical trial at Harvard Cancer Center for solid
tumors, has shown to be effective against animal models of
retinoblastoma.
Retinoblastoma is a rare and serious disease in which
cancer cells grow in the retina of the eye. According to the
American Cancer Society, less than 300 children are
diagnosed with retinoblastoma each year in the United
States. It is the most common type of eye cancer in children
and accounts for 6 percent of all cancers in children under
the age of five. It is most frequently diagnosed in infants
and very young children; the average age of children when
they are diagnosed is 2. (www.cancer.org/cancer/
retinoblastoma)
Current therapies are difficult to tolerate especially in
children, e.g., removal of the eye, intense radiation therapy,
or chemotherapy given either systemically or locally in the
eye, and are limited in their effectiveness. The need for an
effective therapy against retinoblastoma is urgently
needed.
The Company conducted pre-clinical studies using human
retinoblastoma cells (WERI-Rb-1) in nude mice that were
implanted either subcutaneously or directly into the eye,
intravitreally. Treatment with Kevetrin significantly
reduced the tumor volume by more than half in the
subcutaneous tumor model and showed a significant
improvement in the clarity of the eye in mice treated with
Kevetrin as shown in the photographs below and on our
website at www.cellceutix.com/kevetrin.
Given the limited treatment options, devastating effects,
and small patient population, Cellceutix believes that
retinoblastoma would make an excellent candidate for a
phase 2/3 trial once our present phase 1 trial is completed. It
would qualify for a number of FDA programs (Orphan, Fast
Track and Breakthrough) that can exponentially shrink
development time, should clinical data support the current
research.
“While our Phase 1 clinical trial is ongoing, we are planning
for future trials that are aimed directly at the latest
initiatives of the Food and Drug Administration to expedite
development of ‘breakthrough’ technologies to
commercialization,” commented Dr. Krishna Menon, Chief
Scientific Officer at Cellceutix. “The data from the studies
affirm that Kevetrin may be useful in a new tumor type, in
addition to the other indications that we are studying.
Kevetrin has delivered robust results against all indications
tested to date. Cellceutix’s strategy is to have multiple trials
ongoing against multiple cancer types concurrently. We are
conducting testing against several more cancers to
delineate the quickest path to market to build corporate
and shareholder value.”
About Kevetrin™
As a completely new class of chemistry in medicine,
Kevetrin™ has significant potential to be a major
breakthrough in the treatment of solid tumors. Mechanism
of action studies showed Kevetrin's unique ability to affect
both wild and mutant types of p53 (often referred to as the
"Guardian Angel Gene" or the "Guardian Angel of the
Human Genome") and that Kevetrin strongly induced
apoptosis (cell death), characterized by activation of
Caspase 3 and cleavage of PARP. Activation of p53 also
induced apoptosis by inducing the expression of p53 target
gene PUMA. p53 is an important tumor suppressor that acts
to restrict proliferation by inducing cell cycle checkpoints,
apoptosis, or cellular senescence.
In more than 50 percent of all human carcinomas, p53 is
limited in its anti-tumor activities by mutations in the
protein itself. Currently, there are greater than 10 million
people with tumors that contain inactivated p53, while a
similar number have tumors in which the p53 pathway is
partially abrogated by inactivation of other signaling
components. This has left cancer researchers with the
grand challenge of searching for therapies that could
restore the protein's protective function, which Kevetrin
appears to be doing the majority of the time.
Further information on the clinical trial, titled "A Phase 1,
Open-Label, Dose-Escalation, Safety, Pharmacokinetic and
Pharmacodynamic Study of Kevetrin
(Thioureidobutyronitrile) Administered Intravenously, in
Patients With Advanced Solid Tumors," is available at: http:/
/clinicaltrials.gov/ct2/show/NCT01664000?term=
cellceutix&rank=1
About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a
publicly traded company under the symbol "CTIX". It is an
emerging bio-pharmaceutical company focused on the
development of its pipeline of compounds targeting areas of
unmet medical need. Our flagship compound, Kevetrin™, is
an anti-cancer drug which has demonstrated the ability in
pre-clinical studies to regulate the p53 pathway and attack
cancers which have proven resistant to today's cancer
therapies (drug-resistant cancers). Cellceutix also owns the
rights to seven other drug compounds, including KM-133,
which is in development for psoriasis, and KM-391 for the
treatment of the core symptoms of autism. More
information is available on the Cellceutix web site at
www.cellceutix.com.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not
strictly historical, including statements as to revenue
projections, business strategy, outlook, objectives, future
milestones, plans, intentions, goals, future financial
conditions, future collaboration agreements, the success of
the Company's development, events conditioned on
stockholder or other approval, or otherwise as to future
events, such statements are forward-looking, and are made
pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. The forward-
looking statements contained in this release are subject to
certain risks and uncertainties that could cause actual
results to differ materially from the statements made.
Factors that may impact Cellceutix's success are more fully
disclosed in Cellceutix's most recent public filings with the
U.S. Securities and Exchange Commission.
Copyright © 2013 Cellceutix Corporation, All rights reserved. You requested to receive email alerts about Cellceutix at our website www.cellceutix.com Our mailing address is: Cellceutix Corporation 100 Cumming Center, Suite 151-B Beverly, MA 01915
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Cellceutix Conducts Research on Retinoblastoma Cancer
Beverly, MA - Cellceutix Corporation (OTCBB: CTIX) (the
"Company"), a clinical stage biopharmaceutical company
focused on discovering small molecule drugs to treat unmet
medical conditions, including drug-resistant cancers and
autoimmune diseases, is pleased to report that Kevetrin™,
the Company’s lead anti-cancer compound currently in a
Phase 1 clinical trial at Harvard Cancer Center for solid
tumors, has shown to be effective against animal models of
retinoblastoma.
Retinoblastoma is a rare and serious disease in which
cancer cells grow in the retina of the eye. According to the
American Cancer Society, less than 300 children are
diagnosed with retinoblastoma each year in the United
States. It is the most common type of eye cancer in children
and accounts for 6 percent of all cancers in children under
the age of five. It is most frequently diagnosed in infants
and very young children; the average age of children when
they are diagnosed is 2. (www.cancer.org/cancer/
retinoblastoma)
Current therapies are difficult to tolerate especially in
children, e.g., removal of the eye, intense radiation therapy,
or chemotherapy given either systemically or locally in the
eye, and are limited in their effectiveness. The need for an
effective therapy against retinoblastoma is urgently
needed.
The Company conducted pre-clinical studies using human
retinoblastoma cells (WERI-Rb-1) in nude mice that were
implanted either subcutaneously or directly into the eye,
intravitreally. Treatment with Kevetrin significantly
reduced the tumor volume by more than half in the
subcutaneous tumor model and showed a significant
improvement in the clarity of the eye in mice treated with
Kevetrin as shown in the photographs below and on our
website at www.cellceutix.com/kevetrin.
Given the limited treatment options, devastating effects,
and small patient population, Cellceutix believes that
retinoblastoma would make an excellent candidate for a
phase 2/3 trial once our present phase 1 trial is completed. It
would qualify for a number of FDA programs (Orphan, Fast
Track and Breakthrough) that can exponentially shrink
development time, should clinical data support the current
research.
“While our Phase 1 clinical trial is ongoing, we are planning
for future trials that are aimed directly at the latest
initiatives of the Food and Drug Administration to expedite
development of ‘breakthrough’ technologies to
commercialization,” commented Dr. Krishna Menon, Chief
Scientific Officer at Cellceutix. “The data from the studies
affirm that Kevetrin may be useful in a new tumor type, in
addition to the other indications that we are studying.
Kevetrin has delivered robust results against all indications
tested to date. Cellceutix’s strategy is to have multiple trials
ongoing against multiple cancer types concurrently. We are
conducting testing against several more cancers to
delineate the quickest path to market to build corporate
and shareholder value.”
About Kevetrin™
As a completely new class of chemistry in medicine,
Kevetrin™ has significant potential to be a major
breakthrough in the treatment of solid tumors. Mechanism
of action studies showed Kevetrin's unique ability to affect
both wild and mutant types of p53 (often referred to as the
"Guardian Angel Gene" or the "Guardian Angel of the
Human Genome") and that Kevetrin strongly induced
apoptosis (cell death), characterized by activation of
Caspase 3 and cleavage of PARP. Activation of p53 also
induced apoptosis by inducing the expression of p53 target
gene PUMA. p53 is an important tumor suppressor that acts
to restrict proliferation by inducing cell cycle checkpoints,
apoptosis, or cellular senescence.
In more than 50 percent of all human carcinomas, p53 is
limited in its anti-tumor activities by mutations in the
protein itself. Currently, there are greater than 10 million
people with tumors that contain inactivated p53, while a
similar number have tumors in which the p53 pathway is
partially abrogated by inactivation of other signaling
components. This has left cancer researchers with the
grand challenge of searching for therapies that could
restore the protein's protective function, which Kevetrin
appears to be doing the majority of the time.
Further information on the clinical trial, titled "A Phase 1,
Open-Label, Dose-Escalation, Safety, Pharmacokinetic and
Pharmacodynamic Study of Kevetrin
(Thioureidobutyronitrile) Administered Intravenously, in
Patients With Advanced Solid Tumors," is available at: http:/
/clinicaltrials.gov/ct2/show/NCT01664000?term=
cellceutix&rank=1
About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a
publicly traded company under the symbol "CTIX". It is an
emerging bio-pharmaceutical company focused on the
development of its pipeline of compounds targeting areas of
unmet medical need. Our flagship compound, Kevetrin™, is
an anti-cancer drug which has demonstrated the ability in
pre-clinical studies to regulate the p53 pathway and attack
cancers which have proven resistant to today's cancer
therapies (drug-resistant cancers). Cellceutix also owns the
rights to seven other drug compounds, including KM-133,
which is in development for psoriasis, and KM-391 for the
treatment of the core symptoms of autism. More
information is available on the Cellceutix web site at
www.cellceutix.com.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not
strictly historical, including statements as to revenue
projections, business strategy, outlook, objectives, future
milestones, plans, intentions, goals, future financial
conditions, future collaboration agreements, the success of
the Company's development, events conditioned on
stockholder or other approval, or otherwise as to future
events, such statements are forward-looking, and are made
pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. The forward-
looking statements contained in this release are subject to
certain risks and uncertainties that could cause actual
results to differ materially from the statements made.
Factors that may impact Cellceutix's success are more fully
disclosed in Cellceutix's most recent public filings with the
U.S. Securities and Exchange Commission.
Copyright © 2013 Cellceutix Corporation, All rights reserved. You requested to receive email alerts about Cellceutix at our website www.cellceutix.com Our mailing address is: Cellceutix Corporation 100 Cumming Center, Suite 151-B Beverly, MA 01915
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