P R O - P H A R M A C E U T I C A L S , I N C . Amex: P R W A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E® Exhibit 99.1 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Forward Looking Statements Any statements in this presentation about future expectations, plans and prospects for the Company, including statements containing the words "believes," "anticipates," "plans," "expects and similar expressions, constitute forward looking statements, which are subject to the safe harbor for such statements in the Private Securities Litigation Reform Act of 1995. Future events could cause actual results to differ materially from those indicated by such statements. Reference is made to the factors discussed in the "Plan of Operations" and "Risk Factors" sections of the Company's most recent quarterly or annual report filed with the Securities and Exchange Commission. The forward- looking statements herein represent the Company's views as of the date of this presentation and should not be relied upon to represent the Company's views as of a subsequent date. While the Company anticipates that subsequent events may cause the Company's views to change, the Company disclaims any obligation to update such forward- looking statements. 2 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Mission Develop proprietary carbohydrate compounds with the potential to significantly improve treatments for cancer, liver, inflammatory and microbial diseases. This improvement is based on identifying and exploiting the unique biological specificity carbohydrates have for disease receptors. 3 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Summary • Unique Technology – Multiple drug platforms • Positive pre-clinical and clinical trial results • Regulatory Strategy • Business Opportunities – Multi-billion dollar markets 4 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Technology 5 • Oncology • Fibrosis • Other opportunities |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Overview - Technology • Unique Technology – Drug design using carbohydrates – Five patents issued and eleven pending – Highly specific recognition mechanisms 6 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Strong Intellectual Property Position Carbohydrate Polymers • Composition of matter and field of use patents (5) – U.S. Pat 6,642,205 (11/04/03) – Methods and Compositions for Reducing side effects in Chemotherapeutic Treatments – U.S. Pat 6,645,946 (11/11/03) & U.S. Pat 6,982,255 (01/03/06) & U.S. Pat 6,914,055 (07/05/06) – Delivery of a Therapeutic Agent in a Formulation for Reduced Toxicity – U.S. Pat 7,012,068 (03/14/06) – Co-administration of a Polysaccharide with a Chemotherapeutic agent for the Treatment of Cancer 7 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Composition of Matter and Methods of Delivery Key Claims • Methods and compositions for reducing toxicity of an existing chemotherapeutic drug by co-administering a polysaccharide • UNIVERSAL CARBOHYDRATE LINKER TECHNOLOGY (UCLT™) enhances the delivery of chemotherapy drugs to tumor cells • Covalently binds one carbohydrate compound to a chemotherapy drug • Utilizes carbohydrate specific receptors found on cancer cells to target delivery 8 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Strong Intellectual Property Position 11 new patent applications filed • 2 - enhanced treatment of cancer including reduced side effects • 3 - delivery of anti-cancer drugs • 1 - reducing side effects of chemotherapeutic treatments • 1 - formulation for anti-fibrotic therapies • 2 – carbohydrate derived statins • 1 - composition of anti-microbial agent • 1- compositions and methods to inhibit restenosis 9 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W LEAD COMPOUND 10 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E �� Amex: P R W Targeting Lectins • Lectins are proteins that tightly bind certain carbohydrates • Galectins are a type of lectin that specifically bind galactose molecules • Galectin receptors are predominately on cancer cells • Galectins have been shown to affect cell development, differentiation, apoptosis and tumor metastasis 11 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W • Proprietary polysaccharide that targets Galectin receptors on cancer cells • Increases efficacy and decreases toxicity of chemotherapeutic agents • Currently in Phase ll trials DAVANAT ® 12 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W • DAVANAT ® selectively binds to lectin receptors on cancer cells • Once bound, the polymer releases its payload into the cancer cell Oncology Platform: CARBOSOME™ 13 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Second Platform: Universal Carbohydrate Linker Technology • New chemical entity that contains a carbohydrate backbone 14 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W CLINICAL TRIAL RESULTS 15 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Pre-Clinical Results DAVANAT® mixed with Avastin® and with 5-FU showed best results – SLOWEST TUMOR GROWTH Tumor Weight Gain in Mice Implanted with COLO 205, Human Colon Tumor, Treated with DAVANAT® in Combination with 5-FU & Bevacizumab (Avastin®) 0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0 90.0 100.0 Southern Research Institute (Dose: I.V., Q4D x 4, of 5-FU 50 mg/kg; DAVANAT®: 120 mg/kg; AVASTIN: 20-80 mg/kg) No Treatment AV FU / AV FU-DAV / AV FU-DAV / AV-DAV 16 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Pre-Clinical Results DAVANAT® mixed with Avastin and with 5-FU showed best results – Mice Show Healthy Weight Gain Total Weight Gain of Mice Implanted with COLO 205, Human Colon Tumor, Treated with DAVANAT® in Combination with 5-FU & Bevacizumab (Avastin®) -8.0 -4.0 0.0 4.0 8.0 Southern Research Institute (Dose: I.V., Q4D x 4, of 5-FU 50 mg/kg; DAVANAT®: 120 mg/kg; AVASTIN: 20-80 mg/kg) No Treatment AV FU / AV FU-DAV / AV FU-DAV / AV-DAV 17 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Pre-Clinical Results DAVANAT® mixed with Avastin and with 5-FU showed best results – Clinical Benefit Index = Lowest Toxicity and Best Efficacy 18 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W 0 10 20 30 40 0 10 20 30 40 AUC Hematocrit Hemoglobin Red blood cells White blood cells Platelets Clinical Trial Results DAVANAT® mixed with 5-FU eliminated the expected drop in blood levels from chemotherapy 19 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Clinical Trial Summary Results • 48 patients dosed with DAVANAT ® /5-FU in Phase l/ll, Line three and four clinical trials • Stabilized 43% of end stage patients with measurable disease: 2-13 months • Maximum Tolerated Dose/Dose Limiting Toxicity not reached • DAVANAT ® allowed increased 5-FU exposure with no toxicity increase Ongoing • Dosing biliary and colorectal cancer patients in Phase ll, line one trials: – Colorectal (8 patients dosed) – 3 PR; 4 stabilized up to 10 months – 43% Objective Response (more than 30% shrinkage) 20 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Beyond Oncology -New Platforms- • Use Proprietary IP to Design New Drugs • Fibrosis – Multiple Indications • Anti-Microbial • Synthetic Statins (Cholesterol) 21 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W FIBROSIS 22 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Fibrosis - Background • Worldwide, 170 million people are infected with chronic hepatitis C • 10-40% of patients respond to current therapies (notably, removal of cause) – There are no effective therapeutic options – 1.4 million deaths per year attributed to chronic liver disease – In the U.S., liver disease is a top 10 disease-related cause of death • Liver fibrosis is an outcome of persistent hepatic inflammation • World wide market in excess of $4 billion • Research collaboration with Dr. Scott Friedman, Director Liver Diseases, Mt. Sinai School of Medicine & President, American Association for the Study of Liver Diseases • PRO-GR 300, a first in class, carbohydrate compound has shown in pre-clinical models to not only arrest disease progression but also to reverse disease progression 23 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Reduces the production of Collagen Collagen is central to fibrogenesis diseases and the scarring of organs. Reduces Expression of Matrix Metalloproteinase -2 (MMP-2) MMP-2 has been correlated to the severity of fibrosis in hepatitis C. Reduces Expression of TGFBR1 TGFBR1 plays a key role in initiating the cascade of events causes the formation of fibrosis / scar tissue Mechanism of Action - Mechanism of Action - Effect Effect on Fibrotic Markers In-vitro on Fibrotic Markers In-vitro Addition of PRO-GR 300 to fibrotic liver cells: 24 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Reversal of Fibrosis with PRO–GR 300 after 4 weeks of treatment Liver Fibrosis, induced by injection of chemical toxin for 8 weeks Rat Fibrosis Model Proof of Concept Proof of Concept 25 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Other Fibrosis Applications • The same receptors influence many types of Fibrosis • Therefore PRO-GR 300 may be effective in different types of Fibrosis • Chemical toxicity, microbial infection & physical injury cause hepatic, renal, cardiac and pulmonary fibrosis • Kidney Fibrosis – 12 million people suffer from kidney fibrosis in the U.S. – Research collaboration with Brigham and Women's Hospital - affiliate of Harvard Medical School 26 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Regulatory Strategy 27 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Regulatory Strategy • Submit final report for completed Phase II end stage patient trial • Continue Phase II trials underway • Drug Master File (Mfg data) to FDA • Initiate IND for non-intravenous indications, e.g., Melanoma • File for Approval to Market DAVANAT® as Excipient with 5-FU • Animal studies needed to add DAVANAT® to other chemos • Regional partnership approach for DAVANAT® • Partner for Phase III trials Oncology Fibrosis • Animal studies needed to extend proof of concept • Accelerate liver & kidney pre-clinical trials • File IND for human trials • Seek partnership 28 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Product Development Pipeline Jan 2008 PRODUCT INDICATION DISCOVERY PRE-CLINICAL PHASE 1 PHASE 2 DAVANAT ® / 5-FU line I DAVANAT ® / 5-FU/LV/ AVASTIN ® line I DAVANAT ® / 5-FU line IV PRO-GR 300 Biliary Cancer Ongoing Colorectal Cancer Ongoing All Solid Tumors Completed Liver Disease Microbial Disease PHASE 3 DAVANAT ® / 5-FU line IV Colorectal Cancer Completed PRO-NAC 050 29 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W 2008 Milestones • Submit Drug Master File (DMF) - First Quarter • File Investigative New Drug (IND) Application: Triggers FDA Review of DMF - Second Quarter • DMF approval projected – Second/Third Quarter • License DAVANAT® in regions outside U.S. – Third Quarter • Submit data needed for approval as excipient to 5-FU – Fourth Quarter • Continue to complete research agreements • Actively pursue corporate partnerships 30 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Business Opportunities Several Multi-billion dollar markets can be addressed 31 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Business Opportunities • Oncology – Excipient to 5-FU, improve results & reduce side effects – Eliminates/reduces need for additional drugs to treat side effects – Extend patent life of chemo drugs – Only animal studies needed to combine with other chemo – New indications - melanoma – Regional licenses – Partner with big Pharma to fund trials • Avastin® sales in 2007 $2.9 billion – Works with 5-FU – Low Cost to Produce 32 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Business Opportunities Several Multi-billion dollar markets can be addressed • Fibrosis – Accelerate pre-clinical trials based on proven safety of carbohydrates and DAVANAT® • Liver • Kidney – File IND – Start clinical trials ASAP – Early partnerships – New indications – lung fibrosis 33 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W CORPORATE 34 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Corporate Summary • PRW began operations in 2001 • Five U.S. patents issued • Capital raised: $39.5 million (cumulative) • Shares outstanding: 40.4 million (11/01/07) • Fully diluted: 52.1 million (11/01/07) • Completed Phase l/ll cancer trials, line 3-4 • Two ongoing Phase ll trials, line 1, biliary & colorectal cancer • PRO-GR 300 in pre-clinical trials to treat fibrosis • Plan to commercialize technology and products through corporate partnerships • Carbohydrate technology platform enables: – New intellectual property – Product line extensions – Safer and more effective drugs 35 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Management Team • David Platt, Ph.D., Chairman & Chief Executive Officer – Co-founder, co-developer of Glycoscience technology. Founder: SafeScience; developed anti-angiogenesis drug. U of Michigan, Weizmann Institute, Hebrew U • Theodore Zucconi, Ph.D., President – 35 + years experience in operations management, R&D, problem solving, product development and strategic planning • Anatole Klyosov, Ph.D., D.Sc., Chief Scientist – Co-founder, co-developer of Glycoscience technology. National Prize in Science & Technology (Russia); Visiting Biochemistry Prof at Harvard. Moscow State U • Eliezer Zomer, Ph.D., Exec. V.P., Clinical Development & Mfg – Former Research Associate at Harvard Medical • David Donabedian, Ph.D., MBA, Business Development (Consultant) – 12 years in life sciences; VP, Bus Dev, Surface Logix; Accenture; Dow Chemical • Anthony Squeglia, MBA, Chief Financial Officer – 25 years in finance, strategic planning, marketing & investor relations • Maureen Foley, Chief Operating Officer – 25 years in biotech, high-tech in operations management • Bruce Silver, M.D., Medical Director (Consultant) – 20 + years in oncology; CRO 36 |
P R O - P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Summary • Proprietary Technology With Multiple Current and Future Applications • Excipient for Existing Chemotherapy Protocols • Reduces or Eliminates Adverse Side Effects and Lowers Cost of Treatment • Proven Effective in Targeting Lectin Receptors Specific to Cancer Cells • New Compound (drug) has Shown Ability to Reverse Liver Fibrosis • Oncology and Fibrosis – Multi Billion Dollar Markets 37 |