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Kalos Therapeutics Inc

Location: Phoenix, AZ

Sector: Life Sciences.

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Kalos Therapeutics, Inc. is a biomedical company developing a class of therapeutic peptides to fight cancer.  These peptides have already shown significant clinical activity in cardiovascular, cancer and veterinary indications. Kalos’ drugs replicate a natural, anti-proliferative activity by disrupting tubulin activity.

Our lead drug candidate, KTH-222, is a safe, non-toxic drug which may be used as 1) a front-line therapy, 2) a long-term maintenance therapy or 3) a co-therapy which reduces time to chemo resistance and minimizes chemo side-effects.  KTH-222 reduces tumor size while addressing complications, such as metastasis, thereby, allowing the patient to maintain a quality of life not seen with chemo therapy treatments alone.

Initial cancer markets include:  pancreatic, ovarian, prostate, lung and liver.  An animal division will develop drugs for the treatment of cancer and renal disease, congestive heart failure and epistaxis.

Business Documents

MG cp Summary

KTH-222 – Human Cancer

Breakthrough technology – Novel therapeutic for unmet medical need in pancreatic cancer and associated complications like metastases.

 

Orphan Drug Designation – U.S. Orphan designation qualifies the sponsor to a seven-year period of market exclusivity upon approval of the drug. Sponsor may apply for FDA orphan research grants, a waiver of Prescription Drug User Fee Act filing fees andtax credits for clinical research costs.

 

Low to no toxicity, well tolerated and limited to no side effects – Our drug could be used as a lead therapy, a second line active therapy or potentially the first long-term maintenance therapy for many cancers.  Based on its low/no toxicity, there is little risk of resistance and when used in combination, chemo amounts can be reduced with an improved quality of life for the patient.

 

KTH-222/variants – Canine Cancer

Pet owners are reluctant to subject their pets to chemotherapy based on Quality of Life (QOL), costs, and outcomes. KTH-222 is well tolerated, fewer, if any side effects, reduces primary tumor, address complications like metastases, improves QOL and can be used in combination with chemo should the owner desire.

 

KTH-222/variant – Retinal disease

Ease of delivery – Kalos has explored delivery of this therapy in retinal disease as a topical, delivered as a viscous drop, or applied to film. The goal is to eliminate or reduce injections into the eye as site fatigue is a problem and compliance of patients is difficult. This approach can be adapted in multiple eye diseases and KTH-222 should follow the pathway of testing previously completed with the parent peptide where vision was restored in AMD simulated animal models.

 

KTV-111 – Animal Epistaxis, Equine athletes

Focused on fluid removal to reduce bleeding in Equine Athletes – A well tolerated, potassium sparing approach to fluid removal to stop bleeding, additive benefits: regeneration of microtubules, and improvement of compromised heart function providing therapeutic benefits to the horses, while being compliant with regulations in each sport or event.

Quality-of-Life Safer, less toxic approach to slowing cancer with fewer side effects.

 

Safety/Toxicity Well tolerated. It is similar to amino acids found in the heart.

 

Addresses metastasis Our drug recognizes the metastasis and attacks these as small tumors.  This is not being addressed by other therapies, and can lead to a long-term maintenance therapy and increased survival.

 

Synergistic Can be used in conjunction with existing therapies to provide a better quality-of-life and progression free survival.

 

Reduction of drug resistance When used synergistically with chemo, the amount of chemo used can be reduced thereby allowing a longer treatment cycle.

George Colberg, Co-Founder, CEO, Chairman

Mr. Colberg is a seasoned corporate finance and management executive. He was CEO of Primary Inc., a company where he pioneered the plan for acquisitions and the business model initiating early efforts in personalized medicine, electronic medical record meshed with patient data and billing and the advanced use of diagnostics. Prior to Primary Care he was a Vice President at the Financial Group managing syndications and equity investment research while raising in excess of $100 million.

 

Mr. Colberg developed the corporate philosophy of Kalos, identified and shaped the strategy behind the primary products, and the commercialization plan for Kalos. He raised the seed round, series A and B rounds and grant financing totaling $3.5 million. He recruited the executive team and scientific advisory board and oversees the clinical development plan.  Mr. Colberg set the strategy for securing US and EU IP patents and the Orphan Drug Designation.

 

Mr. Colberg completed his Bachelor of Science from San Diego State University and attended University California, Berkeley  for a Certification as a Biomedical Executive.

 

Jay Merritt, MD, President and Chief Medical Officer

Dr. Merritt is a medical oncologist with over 20 years’ experience as a biotechnology executive. He most recently served as President and Chief Medical Officer at Adventrx Pharmaceuticals.  He was founding CEO of Imagine Pharmaceuticals, a venture stage company with a small molecule approach to facilitate drug uptake across the blood brain barrier.

 

He began his industrial career at the Upjohn Company leading early stage oncology and infectious diseases clinical research and he played a key role in launching Upjohn’s HIV research program. He subsequently held senior management positions at IDEC Pharmaceuticals (now Biogen Idec), Viagene Inc. and Introgen Therapeutics, successfully advancing ground-breaking biological modalities such as therapeutic monoclonal antibodies for cancer and rheumatologic diseases, and retroviral and adenoviral gene transfer technologies for cancer and HIV.

 

Dr. Merritt graduated from Johns Hopkins University and received an M.D. from the University of Vermont. He trained in Internal Medicine and Medical Oncology at the University of Wisconsin where he was also appointed Assistant Scientist in the Biophysics Laboratory.

 

Michael Kozlowski, PhD, Chief Science Officer

Dr. Michael Kozlowski is an Associate Professor at the Arizona College of Optometry (AZCOPT) at Midwestern University and CSO at Kalos therapeutics. Prior to Kalos, Dr. Kozlowski spent over 25 years in drug discovery and development for several clinical applications including cancer, age-related macular degeneration, and CNS disorders, and has over 40 peer-reviewed publications and over a dozen issued US patents.

 

He has worked with large pharmaceutical (Pfizer, BMS) and biotechnology companies (Geron, Telik, Axiom, Kreido Laboratories).  Dr. Kozlowski has held positions ranging from Research Scientist to Chief Scientific Officer.

 

Dr. Kozlowski holds a BS in Biology from Caltech, a PhD in Neuroscience from the University of California at Irvine, and an OD from the New England College of Optometry.