Presentation on theme: "Cellceutix Corporation"— Presentation transcript:
1 Cellceutix Corporation Compounds For CuresCellceutix Corporation100 Cummings Center, Suite 151-B Beverly, MA 01915CTIX.OBSeptember 9, 2013
2 Safe Harbor Forward-Looking Statements Compounds For CuresSafe Harbor Forward-Looking StatementsTo the extent that statements in this presentation are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.The forward-looking statements contained in this presentation are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix's success are more fully disclosed in Cellceutix's most recent public filings with the U.S. Securities and Exchange Commission.
3 Leo Ehrlich, CPA CEO and Chief Financial Officer Board of Directors ManagementLeo Ehrlich, CPA CEO and Chief Financial Officer Board of DirectorsFounder of Cellceutix in 2007CEO since December 2010
4 ManagementKrishna Menon, RCM, PhD, VMD President, Chief Scientific Officer Board of DirectorsDr. Menon has more than 30 years in drug development for academia and industryMenon's PhD work focused on anti-folate therapy of various cancers. Menon was a Research Associate Scientist at Dana Farber (Harvard University) from 1988 to 1991 and Research Scientist, In Vivo Research (Cancer & Metabolic Diseases), at Miles Laboratories from 1991 to 1993Group Leader, Cancer In Vivo Research and Clinical Development, for Eli Lilly ( ), where he played a key role in lead selection and pre-clinical development of Gemzar and Alimta, well known multi-billion dollar drugsIn 1999, Lilly honored Menon with the President's Recognition Award, the most prestigious award at Lilly
5 Key Acquisition Acquired PolyMedix September 4, 2013 Brilacidin Pipeline consists of 10 compounds for infectious diseases, cancer supportive care and antimicrobial applicationsProprietary computational drug design technologySubstantial equipment assetsBrilacidin completed Phase IIa clinical trialDelparantag - Good Efficacy but with SAE- Possible reformulation$227 million market cap (before bankruptcy) - “Outperform” rating - strong institutional supportBrilacidinSmall molecule, first-in-class defensin-mimetic antibioticCompleted 200-patient Phase II clinical trial in patients with ABSSSI caused by Staph aureusHit primary endpoints, high and low doses outperformed Cubist Pharmaceuticals’ Cubicin in control armPrime candidate to benefit from GAIN Act of 2012Other possible indications include blood stream infections, lung infections and oral mucositisDelparantagAnticoagulant reversing agentMultiple clinical trials showed drug to reverse heparin and low molecular weight heparinWe are in the excellent position to be “Monday Morning Quarterbacking”Adverse side effects; re-formulation possible
6 Active Projects Kevetrin Prurisol (KM-133) KM-391 Breakthrough p53 targeted activatorDrug resistant cancers, e.g., lung, breast, colonPhase 1 at Dana Farber/ Harvard Cancer Center and Beth Israel Deaconess Medical Center (BIDMC) began Nov 2012Phase1b trial at University of Bologna for hematological cancersAdditional Phase 2 trial at BIDMC for renal cell carcinomaPrurisol (KM-133)PsoriasisFDA 505(b)(2) application to be filedDrug manufacturing completed by Dr. Reddy’s Labs (SYMBOL:RDY)KM-391Autism
7 Kevetrin for Cancer Unique chemistry Strong IP position; many novel compounds in patent application Unique mechanism of actionWild type and mutant p53 (p53 is a potent tumor suppressor)Transcriptional dependent and independent mannerp53 is a potent tumor suppressorLarge therapeutic indexPotent anti-tumor activity even in drug resistant tumorsExcellent toxicity profileNo development of drug resistanceNon-genotoxic
8 Kevetrin Phase 1 Dana Farber / Harvard Cancer Center and Beth Israel Deaconess Medical Center (BIDMC)Dose escalation study in chemotherapy-resistant subjects with solid tumorsCycle: treatment once/ week for 3 weeks, followed by 1 week off treatmentp53 status of tumors will be evaluated18 patients enrolled to dateEndpointsSafetyMaximum Tolerated Dose (MTD)Tumor sizeSerum tumor markersBiomarker: increased p21 expression in lymphocytesCompleted 4 cohorts, currently in 5th cohort1 subject completed 7 cycles, 1 completed 4 cyclesNo dose limiting toxicityHave not yet reached maximum tolerated dose5th cohort dose is 7.5 times initial dose; 75mg/m2
9 Kevetrin Phase 1Observed stabilization of disease by restaging in multiple types of cancerEvidence of stable disease by radiological examination in 6 cases, which includes head and neck cancer, ovarian cancer, liposarcoma and clear cell carcinomaDisease progression occurred following stabilization of disease in some casesSubject 103 had 6 months of treatment and 2 successful restaging with stable diseaseSubject 202 completed 4 cycles of treatment*Stabilization was achieved at low doses in terminal patients with relapsed tumors that were resistant to current chemotherapies.Pharmacokinetic profiles and parameters show no evidence of accumulation in plasmaThis points to possibility to increase dose and frequencyp21 biomarker expression in patientsKevetrin activated p21 in 4 out of 5 patients treated with 20 or 30 mg/m2
10 Kevetrin Phase 1No alteration in hematological profile was observed due to KevetrinNo leukopeniaNo neutropeniaNo anemiaNo thrombocytopenia*In contrast, standard cytotoxic chemotherapeutic drugs have adverse effects on hematologyDuring infusion with Kevetrin:No neuropharmacological changes were observedNo adverse effects on cardiovascular systemNo change in subject’s cardiac rhythm or ECGNo change in respiratory rate, minute volume or tidal volume
11 Kevetrin Phase 1 Adverse Events No observed Serious Adverse Events (Grade 3) attributable to Kevetrin to date (5th cohort at 75 mg/m2)Observed Adverse Events (Grade 1, Grade 2):Cutaneous erythema (redness of the skin) was observed in a few subjects, lesser number had pruritusReactions subsided when infusion was completedReactions were manageable with antihistamines and steroidsOccurred without hemodynamic changes
12 Kevetrin Phase 1 Adverse Events The following occurred in at least 1 subject:NauseaVomitingChest tightnessShortness of breathHigh blood pressureFatiguePre-medication with antihistamines or steroids was administered per direction of the attending physician*None were Grade 3 Adverse Events
13 Active Projects Kevetrin Prurisol (KM-133) KM-391 Breakthrough p53 targeted activatorDrug resistant cancers, e.g., lung, breast, colonPhase 1 at Dana Farber/ Harvard Cancer Center and Beth Israel Deaconess Medical Center (BIDMC) began Nov 2012Phase1b trial at University of Bologna for hematological cancers to start 2014Additional Phase 2 trial at BIDMC for renal cell carcinoma to start 2014Prurisol (KM-133)PsoriasisFDA 505(b)(2) applicationKM-391Autism
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