MELBOURNE, AUSTRALIA / ACCESSWIRE / October
1, 2015 / Propanc Health Group
Corporation (OTCQB: PPCH) ("Propanc" or "the Company"), an emerging
healthcare company focusing on development of new and proprietary
treatments for cancer patients suffering from pancreatic and
colorectal cancers, today announced a summary of current activities
and recent achievements which will see the Company ready to
complete several important milestones in the coming months.
Propanc Raises First $1.2 Million of Potential $4
Million Deal:
Recently, the Company issued a note with a principal amount of
$1.2 million to an institutional investor as a bridge financing to
a larger, subsequent financing that may have the potential to
provide the Company with up to $4.0 million. If both parties
proceed, the aggregate deal size will be sufficient to cover
current and future research and development activities leading up
to the preparation and commencement of human trials for their lead
product, PRP.
The Company provided further information regarding this
financing in a Form 8-K filed with the SEC on September 29,
2015.
Numerous Preclinical Activities Underway for The
Company's Lead Product, PRP:
Animal efficacy studies in several tumor cell lines are underway
for PRP with the Company's research partner, vivoPharm, in Hershey,
PA. The studies are investigating the optimization of the PRP
treatment, which are expected to even further improve PRP's
anti-tumor effects compared to the previous pilot studies. The
human xenograft orthotopic models (human derived tumors
transplanted into immunocompromised mice) will be used to support
upcoming regulatory agency meetings and licensing discussions.
Additionally, pharmacokinetic studies are underway in order to
generate important information regarding how the two proenzymes in
the PRP formulation are metabolized throughout the body. The data
generated will provide important information regarding dosing for
each of the two proenzymes and therefore optimizing the treatment
regimen for PRP in future human studies.
One additional animal efficacy study conducted at vivoPharm has
incorporated a mouse tumor transplanted in immunocompetent (immune
functioning) mice. Blood and tissue samples harvested from this
study are presently being prepared to be sent to Adaptive
Biotechnologies in Seattle, WA, to characterize the immune response
when compared to untreated and PRP treated mice.
Important Scientific Discoveries Resulting in Additional
Patent Applications:
Whilst undergoing cell culture studies investigating the effects
and underlying mechanisms of PRP treatment at the University of
Jaѐn in Spain, it was recently reported that important scientific
observations were made which has been sent to the Company's patent
attorneys for evaluation. Since then, additional experiments have
been conducted confirming the initial results.
Coincidentally, results from recent animal studies conducted at
vivoPharm in Hershey, PA, have also been sent to the Company's
patent attorneys for evaluation.
The Company's lawyers are preparing provisional patent
applications and are presently waiting on further results from both
research partners in order to maximize the strength of each
application.
The Company reaffirms its commitment to announcing findings from
these recent studies to shareholders at the earliest opportunity,
once the patent applications are filed. Management is excited about
these results which helps to further establish the Company's
intellectual property portfolio, as a global leader in the field,
which they believe has significant implications regarding the
commercial potential of PRP as a long term therapy for the
treatment and prevention of metastatic cancer from solid
tumors.
Preparation for Regulatory Agency Meetings and
Initiation of Partnering discussions:
Preparation is underway for planned regulatory agency meetings
early next year, where Propanc management is expected to meet with
the Federal Institute for Drugs and Medical Devices in Germany
(BfArM), European Medicines Agency (EMA) and US Food and Drug
Administration (FDA). The scientific advice meetings will be an
opportunity to discuss key activities planned for the future
development of PRP, including animal safety/ toxicology studies and
the proposed clinical pathway for human studies in Phase I and
II.
Orphan Drug Designation:
Further, as a result of completing the recent cell culture and
animal studies with its research partners, the Company has selected
pancreatic cancer as its lead indication for human studies. Given
the background development history of PRP, its uniqueness as a
potential treatment for pancreatic cancer, and the size of the
target patient population for pancreatic cancer, management will
seek Orphan Drug Designation for PRP for this indication in each
jurisdiction. When a product is designated orphan drug status in a
particular jurisdiction, the relevant agency will assist with
advising the Company on its development activities, reduce the
costs of various regulatory agency submissions and provide market
exclusivity for a period anywhere between 7 to 10 years.
Once the scientific advice meetings with regulatory agencies are
completed, the Company will engage potential licensing partners to
determine their interest in partnering with Propanc as it enters
human trials next year.
Evaluation of Overseas R&D tax Schemes and
Government Grants:
The Company over a number of years continues to receive an
R&D tax refund from the Australian Government for its research
and development activities. Since broadening its level of R&D
activities all over the world, the Company has decided to undertake
a strategic evaluation of countries around the world which fund
R&D and where it could potentially qualify for government
grants. Management has decided to focus its efforts into
researching grants in the US and EU, which could not only reimburse
R&D activities undertaken, but could also provide a potential
source of financing for future R&D activities for its lead
products and research programs.
Plans for Listing on a National
Exchange:
The Company's management team continues to work closely with its
advisors and has carefully considered all financing deals presented
to ensure any investor is supportive towards the Company's
ambitions for up listing onto a national exchange. If the current
institutional investor decides not to proceed with the subsequent
financing, management is confident the Company remains an
attractive opportunity to investors willing support its plans to up
list sometime next year.
"We are extremely pleased with the progress made with our recent
financing and R&D activities," said James Nathanielsz,
Propanc's Chief Executive Officer, "The important, incremental, but
necessary steps taken this year, has enabled us to grow in
confidence that we are on the right pathway to achieve long term
commercial success."
Propanc aims to fast track the development of proenzyme related
oncology products into clinical trials for colorectal and
pancreatic tumors, initially. According to Global Analyst Reports,
the world market for colorectal cancer is expected to reach $8.8
billion by 2020 and the global pancreatic cancer market is
projected to exceed $1.2 billion by 2015.
About Propanc:
Propanc is currently focused on developing new cancer treatments
for patients suffering from pancreatic and colorectal cancers.
Propanc have developed a formulation of anti-cancer compounds which
exert a number of effects designed to control or prevent tumors
from recurring and spreading throughout the body. Propanc's
products involve or employ proenzymes, which are inactive
precursors of enzymes.
In the near term, Propanc intend to target patients with limited
remaining therapeutic options for the treatment of solid tumors
such as colorectal or pancreatic tumors. In future, Propanc intend
to develop their lead product to treat (i) early stage cancer and
(ii) pre-cancerous diseases and (iii) as a preventative measure for
patients at risk of developing cancer based on genetic screening.
For more information, visit: www.propanc.com.
Forward-looking Statements:
Certain of the matters discussed in this announcement involve
risks and uncertainties including, without limitation, those
regarding the Company's ability to establish and maintain the
proprietary nature of its technology through the patent process,
its ability to license from others patents and patent applications,
if necessary, to develop certain products, its ability to implement
its long range business plan for various applications of its
technology, and its ability to enter into agreements with any
necessary marketing and/or distribution partners for purposes of
commercialization. This is not a solicitation to buy or sell
securities and does not purport to be an analysis of the company's
financial position. See Propanc's most recent Quarterly Report on
Form 10-Q and related 8K filings.
Contact:
Regal Consulting
Tel: 702 – 575 – 9157
SOURCE: Propanc Health Group Corporation
Grafico Azioni Propanc Biopharma (PK) (USOTC:PPCB)
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Da Mag 2024 a Giu 2024
Grafico Azioni Propanc Biopharma (PK) (USOTC:PPCB)
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Da Giu 2023 a Giu 2024
