Liprostin Group is an early stage pharmaceutical company with technology to treat Vascular and Pulmonary Diseases. We are preparing for an emergency FDA meeting so that we can conduct a Proof of Concept to treat COVID-19 lung problem patients and rapidly move to Trials III for an FDA approved treatment.
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Liprostin Group - Vascular - Pulmonary Diseases
1. Multilamellar Liposome
LiprostinTM is our Multilamellar Liposomal Drug Delivery System.
LiprostinTM treats Vascular and Pulmonary Diseases with PGE-1.
Licensed the Patent
2. LiprostinTM is Prostaglandin (PGE-1) encapsulated in a
patented multilamellar liposome.
PGE-1 is Alprostadil – an FDA approved Generic Drug
• Vasodilator - increases blood circulation
• Potent Anti-inflammatory
• Anti-thrombotic - reduces formation of blood clots
• Promotes the growth of capillaries
3. Advantage LiprostinTM
Infused raw PGE-1 dissipates in about 70 seconds.
LiprostinTM post infusion is flat for 5 min. / declines by 50% next 5 min.
LiprostinTM in-vitro has half-life of 1 to 2 hours.
Liposome is charged to target Inflammation.
Delayed delivery maximizes PGE-1 effectiveness:
Treats Peripheral Artery Disease (PAD)
Possible COVID Lung Disease treatment
• Acute Respiratory Distress Syndrome
• Mitigation of Cytokine Storm Inflammation
High Pressure Liquid
Chromatography (HPLC)
7. Large Potential Market
Diabetic Foot Ulcers
$9-13 billion cost to payors
Lower Extremity Amputations
$4 billion cost to payors
Can be treated with LiprostinTM
8. Earlier Successful Clinical Trials 1, 2 a-b-c
Phase I Clinical Safety Trial: demonstrate drug safety with no
serious side-effects and no adverse events.
Phase II - A Clinical Trial: evaluate the safety and efficacy of
intravenous administered LiprostinTM in patients with
Peripheral Occlusive Arterial Disease.
Phase II - B Clinical Trial: to test effectiveness in treating
intermittent claudication (pain) and determine Maximum
Walking Distance before pain returned
Phase II – C Clinical Trial: treat Peripheral Vascular Disease
(“PVD”) and venous ulcers.
10. • Method for Treating Vascular Disease by Administering
a Liposomal Prostaglandin Composition
• Encapsulation of PGE-1 in a liposome solves the
problems of instability, short in vivo half-life, and rapid
degradation experienced with PGE-1 in its raw form.
Patent claims include treatment of:
Peripheral
Vascular
Disease
Critical
Limb
Ischemia
Intermittent
Claudication
Walking Pain
PATENT 9,962,393 B1
Issued 5-8-18 to David P Summers, Licensed to Liprostin Group, Inc.
11. The contract manufacturer encapsulated
Prostaglandin (PGE-1) into a Multilamellar
Liposome in the absence of a buffer.
Freeze Dried it for stability and shelf life
It was intravenously infused in clinical trials
The proprietary Liposome used in these trials is
now patented and licensed to Liprostin Group, Inc.
Sample for Clinical Trials
12. Liposome Patents using partition enhancing buffers likely expired.
Our Licensed Patent: multilamellar liposomal technology
made in the absence of a partition enhancing buffer (issued 2018)
The liposome targets inflammation and remains effective during its
1 to 2-hour half-life – which raw PGE-1 cannot do.
If Prostaglandin is used in USA with a liposome – others should
obtain a license from Liprostin Group, Inc.
Importance of Patent
13. Competition – Blood Thinners
Asprin Cilostazol® (Pletal®) Trental® (Pentoxifylline®)
• No therapeutic benefits, or ability to stop the disease
• Does not promote healing of wounds
• Does not promote growth of capillaries
14. Our Primary Strategy
• Find Pharma partner who sub-licenses the patent and develops
our method for Treating Vascular Disease by Administering a
Liposomal Prostaglandin Composition / encapsulated PGE-1.
• Alprostadil is PGE-1, and is an FDA approved Generic Drug
• Pharma
• Up-front payment
• Milestone payments
• Royalty on sales
• Pays development & FDA registration costs
• Markets product
15.
16. The COVID-19 pandemic has killed 373,337 persons as of May 31, 2020.
Deaths are primarily caused by acute respiratory distress syndrome
(ARDS) and by cytokine storm syndrome—i.e., a state of
hyperinflammation leading to multiorgan failure.
We have an approach to ameliorate that inflammatory problem using
PGE-1 and believe that our own FDA Trials 1, 2 a-b-c, and the science as
published in third-party research supports its use in clinical trials.
We want to immediately conduct a Proof of Concept.
17. Our Development Strategy
1. COVID Lung Problem – pursue it now
• Need FDA accelerated IND approval – we have Regulatory Expertise
• Conduct Proof of Concept (POC) – test 10-20 COVID patients
• With success BARDA funding for larger FDA study and New Drug App.
• https://www.medicalcountermeasures.gov/app/barda/coronavirus/COVID19.aspx
• Pharma Partnership fallback in case Proof of Concept stalls
2. Pharma Partnership – pursue it now & in August
• Chinese – Gerald Yakatan Ph.D. connects in August when in China
• Other – Namrata Chand will start calling our list (20 – 30 prospects)
• OBJECTIVE – Cash Sub-License Fee / Royalty for us
• Trials financed and managed by Pharma Partner
3. Clinical Trials – best to have a Pharma partner
• If pathway 1 and/or 2 fails, then we fund and manage the trials
• Clinical Trials III -- Efficacy & Safety – larger sample size
22. COVID-19 ARDS and Cytokine Storms
•COVID-19 invades respiratory cells and kills them.
•Triggers Cytokine / immune system response.
•Cytokines coordinate subsequent inflammation.
•Inflammation targets infected cells.
•Too many Cytokines cause "cytokine storms" that
rampage through the blood, destroying lung tissue,
clogging airways, and cutting off oxygen supply.
•Acute Respiratory Distress Syndrome (ARDS) can result.
•ARDS / Cytokine Storms primary cause of COVID death
23. PGE-1 - potent suppressor of inflammation
• PGE-1 is a potent suppressor of inflammation, vasodilator,
platelet anti-aggregator, cytoprotective to normal cells,
inhibitor of viral replication.
• Encapsulated PGE-1 in our Multilamellar Liposome has a
half-life of 1 to 2 hours vs. 70 seconds for raw PGE1.
• Multilamellar Liposome is charged to target Inflammation.
• Extended half-life improves anti-inflammatory response.
24. Example of White Paper Third-Party Research
Clinical effect of Alprostadil in patients with septic shock associated with acute respiratory distress syndrome
https://core.ac.uk/display/120225699 http://www.plamj.org/index.php/plamj/article/view/1626/1614
2017 – CONCLUSION -- Alprostadil® = PGE-1
Alprostadil can improve the lung function in patients with septic
shock associated with Acute Respiratory Distress Syndrome
(ARDS), can shorten the time of mechanical ventilation, ICU and
hospital stay, and can reduce the mortality rate, which may be
associated in that Alprostadil reduces systemic inflammatory
reaction and enhances immunity by improving microcirculation.
25. Proof of Concept (POC)
• Obtain Accelerated FDA Investigational New Drug (IND) Application
• Need hospital willing to treat COVID-19 patients.
• We provide samples for 10-20 COVID-19 hospitalized patients.
• POC may only last 1-mo. contingent upon available patients.
• IF POC successful (hospital determines success threshold),
THEN apply to BARDA or OTHER for larger trial funding.
• OBJECTIVE is to acquire FDA New Drug Application.
• IF POC stalls, THEN find Pharma partner for our vascular disease
treatment and prepare for Trials III -- Efficacy and Safety.
26. Regulatory Team (all are founders)
Gerald J. Yakatan, Ph.D. – FDA Regulatory Expert
• During 1966, he founded IriSys, Inc.
• IriSys is a contract pharmaceutical product development and FDA consulting firm
• Plans and engages in FDA meetings for U.S. and international clients
• Pharmaceutics Chair at the University of Texas at Austin
• Vice President for Product Development Worldwide at Warner Lambert/Parke Davis
• Founder and CEO at Tanabe Research Labs, USA
Jackie R. See M.D., F.A.C.C. – Co Principal Investigator
• Chief Scientific Medical Advisor, Stem Cell Save The Children, LLC.
• Board-Certified Internist, a Fellow of the American College of Cardiology
• Pioneer of the specialty of Interventional Cardiology
• Founded teaching program of Interventional Cardiology at UC Irvine School of Medicine
• He invented the encapsulation of PGE1 with Liposomes for erectile dysfunction treatment
• Licensed in 2004, his patent (now expired), to David P. Summers for Liprostin
27. Scientific Advisors
Undurti N Das, MD, DSc, FAMS, FRSC: Physician/Scientist
• Dir. of Bioscience Research Centre, GVP Medical College and Hospital, Visakhapatna, India
• Lipid-based drugs for cancer, lupus, diabetes mellitus, and drug resistant microbes
• Published 500 research papers, published 4 books, and has 5 USA patents
• Founding Editor of Lipids in Health and Disease journal by BMC, London
• Research Professor, Surgery, Nutrition, Physiology, SUNY Medical University, Syracuse, NY
• MD-1981 in Internal Medicine; DSc-in Biotechnology both from India
28. Management Team (all are founders)
Leo Womack – Chairman & Secretary
• Founding member of Houston Angel Network (HAN) -
• Served as its President and Chairman and an active member
• Chairman of Petrolia Energy, a public oil and gas exploration company
• Active in the Biotech space
David P. Summers Ph.D. – President, Co-CEO, Director
• Inventor / scientist who developed LiprostinTM
• Received over 30 Biotech and Nutraceutical Patents
• In 2016, he filed three LiprostinTM related patents ( first is now granted )
• Founded three public healthcare companies with combined sales of $100 million
Bruce Badeau – Venture Architect – Co-CEO, Director
• Wrote the business plan for AngioSoma, the predecessor of Liprostin Group, Inc.
• Led the move away from the public entity controlling Summers IP
• Organized Liprostin Group, Inc.
• In 1996 Founded First Sovereign Equity Research, financial modeling, and deal structuring
29. Directors (all are founders)
C. Richard Piazza – Director
• Founded La Jolla Capital Partners, a healthcare Investment Banking Firm.
• Executive with 38 years in medical devices, pharmaceutical, and biotechnology
• CEO of Ohmeda, Smith & Nephew Pharmaceuticals, Marquest & VitaGen
• Served advisory boards of Advamed, Biocomm, and BioHouston
• Helped FDA and Congress craft the FDA Modernization Act for Medical Devices
Howard R. Asher – Director
• Founded Regulatory Affairs Certified Advisor, an FDA focused consulting firm.
• Globally recognized expert in life sciences, healthcare and regulatory affairs
• Began his career in life sciences in 1969 with Pfizer, followed by Baxter and Bayer.
• Founded Advanced Bioresearch Associates, FDA Regulatory Affairs and CRO firm
• Sun Microsystems - Group Director of Global Life and Health Sciences.
