More Effective Better safety Less expensive Dr. Mewa Singh CEO www.nanomeda.com Improving companion animal treatment and fulfilling the Veterinarian’s need to treat cancer in pets The problem: a proven effective human therapy is unavailable to canine patients Paclitaxel (Taxol) was administered to 25 dogs with histologically confirmed malignant tumors at a dosage of 165 mg/m2 i.v. over 3-6 hours every 3 weeks. Dogs received premedication with antihistamines and corticosteroids to reduce hypersensitivity reactions. However, 64% of the dogs still experienced allergic reactions. Six dogs (24%) had grade 3 or 4 neutropenia, 6 dogs (24%) required hospitalization and 3 dogs (12%) died of sepsis. Five dogs (20%) had a partial response (osteosarcoma [2 dogs] mammary carcinoma [2 dogs] and malignant histiocytosis [1 dog] for a median duration of 53 days. The overall toxicity was unacceptable at the 165 mg/m2 dose. Therefore, subsequent evaluations of paclitaxel in tumor-bearing dogs should a starting dose of 132 mg/m2 i.v. every 3 weeks. J Vet Intern Med. 2004 Mar-Apr;18(2):219-22. Efficacy and toxicity of paclitaxel (Taxol) for the treatment of canine malignant tumors. Poirier VJ1, Hershey AE, Burgess KE, Phillips B, Turek MM, Forrest LJ, Beaver L, Vail DM. 1 Department of Medical Sciences, School of Veterinary Medicine, University of Wisconsin-Madison, 2015 Linden Drive, Madison, WI 53706, USA. A Solution TaxolCurTM formulation is soluble in water without a toxic carrier Opportunity What animal drugs are eligible for conditional approval? Only drugs for minor species or minor uses in a major species are eligible for conditional approval. Minor species are all animals that are not one of the seven major species: horses, dogs, cats, cattle, pigs, turkeys, and chickens. A minor use in a major species is the use of a drug in a major species for a condition that occurs: Infrequently and in only a small number of animals each year; or in a limited geographic area and in only a small number of animals each year. A drug to control pain in dogs with bone cancer is eligible for conditional approval because fewer than 70,000 dogs typically get bone cancer each year. Accomplished (October 2019) 1. R&D 2. Manufacturing 3. Pre-clinical TaxolCurTM is available as a stabilized lyophilized product with an extended safe shelf life and is reconstituted before use with sterile water Lyophilized crystals (freeze-dried) Low cost manufacturing for affordability to masses Quality Analysis Zeta Potential HPLC TaxolCur Time 5 minutes Dissolution Dramatic efficacy with TaxolCurTM Pancreatic Cancer L3.6pl TaxolCurTM Initial dose of 10 mg/kg q4d was increased to 20 mg/kg, day 18 CurNanoTM maintenance therapy DOT TaxolCur TM Active drug dosing (paclitaxel) was stopped and only curcumin was dosed through end of study – no recurrence Pancreatic cancer – orthotopic model with a highly aggressive human CDX L3.6pl Improved formulation with greater efficacy and reduced side effects October 2019 NanoMeda Inc. TaxolCurTM is efficacious in preventing tumor growth Treated Normal pancreas remained Untreated Day 16* No normal pancreas left Note that the spleen is clearly visible and normal with little tumor evident in the treated animals (green circles), whereas it is subsumed by the tumor growth in the placebo / control animals. * 15/20 treated animals were still alive at Day 42 while 17/20 of the control animals were dead TaxolCurTM is safe, animals were healthy and maintained weight Both groups above were treated for 45 days with TaxolCur and then had no treatment or were placed on curcumin maintenance therapy. L3.6PL Orthotopiic Pancreatic Cancer Survival Graph with TaxolCur™ treatment (IP, q4d) No survival benefit at 10 mg/kg dose Percent survival 100 Survival benefit at 20 mg/kg dose 80 60 40 20 0 0 5 10 15 20 25 30 35 40 DOT Dose increased from 10 mg/kg to 20 mg/kg Group 1 - Vehicle Group 2 - Nano Paclitaxol @ 10 to 20mg/kg TaxolCur™ TM TaxolCur is more effective than Abraxane® Mew-Paxel is TaxolCurTM At half the Abraxane dose, Panc-1 pancreatic cancer flank xenograft was effectively t Previous study conducted at Northwestern University Discovery Technology Center Possible to track drug in system I would remove this slide from the presentation until and unless we can get much better images (and it would require purchase of filters for Woodland) Hybrid-NanoEngineering™ Combination therapies are fast becoming the cornerstone of a next wave cancer treatments, but why are they so important? We know that precisely targeting drivers of cancer can improve patient responses – a good example is the use of EGFR inhibitors in EGFR mutated tumors – however, cancer is a complex and evolving disease which can limit the effectiveness of monotherapy which usually fail after some time. Using combinations of drugs to inhibit different cancer mechanisms has the potential to target distinct tumor cell populations and shut down bypass mechanisms that enable cancer cells to escape death. TM TM TaxolCur is a drug designed to have two active agents for treating cancer. TaxolCur is a combination of a well-studied and effective chemotherapy with a natural product that has shown promise in treating some types of cancer and providing benefits to support chemotherapy. From The Mayo Clinic Can curcumin slow cancer growth? Answer From Timothy J. Moynihan, M.D. At this time, there isn't enough evidence to recommend curcumin for preventing or treating cancer, but research is ongoing. Curcumin, a substance found in the spice turmeric, has long been used in Asian medicine to treat a variety of maladies. Now some research suggests that curcumin may help prevent or treat cancer. Curcumin is thought to have antioxidant properties, which means it may decrease swelling and inflammation. It's being explored as a cancer treatment in part because inflammation appears to play a role in cancer. Laboratory and animal research suggests that curcumin may prevent cancer, slow the spread of cancer, make chemotherapy more effective and protect healthy cells from damage by radiation therapy. Curcumin is being studied for use in many types of cancer. Studies of curcumin in people are still in the early stages. Clinical trials are underway to investigate curcumin as a way to prevent cancer in people with precancerous conditions, as a cancer treatment, and as a remedy for signs and symptoms caused by cancer treatments. https://www.mayoclinic.org/diseases-conditions/cancer/expert-answers/curcumin/faq-20057858 MEDA BIOTECH INC. CONTACT: DR. MEWA SINGH 609-902-7128 MYNANOVIEW@GMAIL.COM Data presented herein have been reviewed and approved by: Dr. Michael R. Briggs, President & CSO , Woodland Biosciences