THERANEKRON No Reason for Arachnophobia Georgia Wagner DVM

THERANEKRON No Reason for Arachnophobia Georgia Wagner DVM 1

Content - Background - Product overview - Available studies - Indications and benefits - Market positioning 2

Background human history - Since the early 1970 s in human medicine: Tarantula spider for: § Skin Disorders: blains, pustulae, ecchymosis, weeping eczema, exanthema, abscesses (livide coloration), beginning necrosis, chronic - non healing wounds, in case of pruritus § Blood disorders: sepsis, necrotic inflammatory processes, thrombangitis obliterans Dorcsi M, 1983: Homeopathic pharmacy, issue 5, Karl F. Haug publishing Boericke W. , Handbook of homeopathic materia media Tarantula cubensis 3

Background veterinary Ø Early publications/investigations: in dogs and cattle § Mammary tumours § Panaritium, footrot § Retained fetal membranes Koch and Stein, 1980, May J. , 1976, Field study AT, 2002; Kacar et al, 2007 4

- Mammary tumours in dogs, Koch and Stein, 1980: 60% Observation period: 1976 -1979 50% 40% 71 animals 30% 20% Conservative treatment 10% 0% conservative second course surgical 4 weeks later removal after treatment euthanasia 5

- Panaritium, footrot May J. , 1976: - 26 animals: 90 80 70 24 early stages 2 cases purulent changes 60 50 40 30 20 10 0 one injection + two injections AB surgery 6

Retained fetal membranes; Field study AT, 2002: 78% retained fetal membr. 100 16% Panaritium 90 80 6% others 70 vaginal trauma, 60 50 vaginal necrosis, 40 udder trauma, 30 20 interpedicular eczema, 10 laminitis 0 very good to good results moderate to unsatisfying results 7

Retained fetal membranes: Kacar et al, 2007 100 90 80 70 60 50 40 30 20 10 0 25 20 15 10 5 0 theranekron treatment placebo group incidence retained placenta theranekron treatment placebo group Vaginal discharge 8

Background veterinary 1 ØHomeopathic literature: Tarantula cubensis is indicated: § in case of painful, inflammative insect bites (deeply red) § in case of carbuncles and boils with severe burning pain, § abscesses with discoloured (bluish) margins, § chronic wounds with a tendency to persist, § septic fever, generalised septicaemia, purulent skin inflammation Don Hamilton, 2005: Homeopathy for dogs; Stauffers homeopathic paperback, 1986; Keller, Greiner homepathic drugs, 1995; Mezger, sighted homeopathic pharmacy, 1988 9

Product overview Where does Theranekron come from? From the Bird Spider `Phormictobus cubensis´ to the final product Theranekron! 10

Product overview 1 Homeopathic solution for injection Indications corresponding to homeopathic picture `demarcation´ Target species: horses, cattle, sheep, goats, pigs and dogs Side effects: Sometimes: pain at injection site Rarely: skin pustulae, swelling of injection site 11

Available studies § Iranian Studies: ØEvaluation of wound contraction and epithelialisation after subcutaneous administration of theranekron in cows OBJECTIVE: Assessment of wound contraction and reepithelialisation in artificial full thickness skin wounds RESULTS: siginificant stimulation of epithel growth during the first 14 days of healing. Sardari K, et al, 2006 12

Iranian study Theranekron Penicillin 13

Available studies 1 § Turkish Studies: ØInvestigation of efficacy of theranekron and UT forte for the treatment of retained placenta in cows ØThe effect of Tarantula cubensis extract applied in pre- and postoperative period of canine mammary tumours ØImmunohistochemical findings of canine mammary adenocarcinomas after therapy with tarantula cubensis Gürbulek et al, 2006; Gültiken and Vural , 2007; Gültiken et al, 2010 14

Turkish studies – Gürbulek 2006 § Investigation of efficacy of theranekron and UT forte for the treatment of retained placenta in cows 35 cows with confirmed diagnosis, 3 treatment groups (A, B, C) OBJECTIVE: Efficacy of Theranekron as single treatment and in combination with an antibiotic RESULTS: § Biopsy results (neutrophil gr. , inflammatory cells) best in group C § Release of fetal membranes significantly shorter in group C (p<0. 05) § Time to first estrus postpartum significantly shorter in group C § Pregancy rates higher in group C 15

Turkish studies - Gültiken 2007 The effect of Tarantula cubensis extract applied in pre- and postoperative period of canine mammary tumours 30 dogs divided into two groups: 10 bitches: Surgery 20 bitches: Theranekron (50% malign, 50% benign ) OBJECTIVE: growth regression of tumours (both malign and benign), long time protection RESULTS: all benign tumours reacted with size reduction up to 100%, malign tumours became more solid. Theranekron dogs showed no new masses after a year. Metastases were seen in 10% of dogs. 16

Turkish studies - Gültiken 2010 Immunohistochemical findings of canine mammary adenocarcinomas after therapy with tarantula cubensis 13 female dogs, 3 ml/10 kg administered three times in a weekly interval. One week later tumours were removed surgically. OBJECTIVE: Changes in tumour size and consistency, resulting immunohistochemical findings (FGF, VEGF, Bcl-2, K 67). RESULTS: FGF, VEGF remained unchanged, Bcl-2 was highly reduced, indicating increased apoptosis in target (tumour cells) K 67 was also highly reduced indicating reduced mitotic activity of tumour cells 17

German Studies – Walter 2011 § Two investigational efficacy studies in female dogs with mammary tumours Study 1: conservative treatment: 3 times Theranekron in a weekly interval, two follow ups (4 and 9 month after last injection) V 1: V 3 -36 V 3: FUP I -16 4 24 -20. 0 180. 0 380. 0 580. 0 18 780. 0

German Studies – Walter 2011 - 1 Study 2: surgical treatment: Theranekron once a week before surgical removal, one follow up 4 -5 weeks after surgery 20 18 40% complex Carcinoma 18 simple Adenoma 16 Adenocarcinoma 14 komplex Adenoma 12 8 6 9% tumour increase 12 tumour decrease 6 4 9% 5% 4 14 8 folliciular Hyperplasia 13% 11% total number tumours 10 benign mixed tumours Lipoma 10 16 5% 2 0 ix 19 ia as rs ou a m tu pl er yp ed r. H la iu llic fo a m om a a m no en Ad ci ar a m no ci om en ar C Ad ex m pl gn ni po Li be m ko e oc pl ex 1 en m pl m 0 Ad si co 2

German Studies – Walter 2011 - 2 CONCLUSION § Trial 1: With regular administration intervals all tumours showed size reduction during Theranekron treatment. Longer intervals resulted in partly extreme tumour growth § Trial 2: Single theranekron injection also had a tumour reducing effect. Clinical observations: enduration, size reduction and encapsulation Demarcation could not be verified by histology 20

NIS Slovak Republic -2011 Non interventional study (postmarketing trial) with Theranekron All target species: 201 animals defined indications 70% 50 60% 73% 50% 40 40% 30 30% 26, 4% 23, 3% 24, 9% 20 20% 10% 0% 9, 5% 10 16% 9% 9% horse cattle dog 0, 5% 1% pig sheep goat 0 support of lesions in demarcation birth canal 14, 4% Panaritium retained fetal infections memb. 1, 5% bubonics 21

NIS Slovak Republic -2011 - 1 Results showed that Theranekron has been successsful : Healing Rate Type of Application 43. 3% 45. 0% 40. 0% 35. 0% 96 100 50. 0% 90 80 34. 3% 70 30. 0% 60 25. 0% 58 50 20. 0% 15. 9% 15. 0% 10. 0% 43 40 30 6. 5% 20 5. 0% 4 10 0. 0% after 1 st treatment after 2 nd treatment after 3 rd or 4 th treatment no healing 0 THE only Antibiotic comb. NSAID comb. both NSAID +AB 22

Indications `corresponding to homeopathic picture´ - Wound healing - Mammatumours in dogs - Retained fetal membranes in cattle, - Wart disease - All conditions where demarcation is desired (infections, deep, old chronic wounds, claw diseases) 23

Benefits - Can be combined wit all conventional therapies - Cost sparing treatment - No withdrawal period - Facilitates removal of tumours - Resolves problematic conditions (vesicular diseases, problematic warts eg. on udder) 24

Market positioning - Tumour diseases (additive, pre-op, conventional) - Wound-healing (large scale, chronic, huge `dirty´, necrotic) - Additive treatment (warts, for septic conditions, metritis, mastitis) - Claw diseases 25

Thank You for Your Attention! Questions? 26