LOS ANGELES, Calif., Apr 02, 2020 (SEND2PRESS NEWSWIRE) -- ROKiT Pharma, Inc., a public-benefit corporation dedicated to putting patients first, announced today it is rapidly progressing through final preclinical studies and moving forward with preparation for the initiation of a Phase 1b/2 clinical trial of ROK-001, a potentially low toxicity cancer drug derived from natural ingredients.
During the Phase 1b trial, ROKiT Pharma's goal will be to determine the safety and tolerability of the drug in humans, as well as understand the pharmacokinetic and pharmacodynamic properties. If ROK-001 gains IND approval, ROKiT Pharma would like to open its first clinical trial during the summer of 2020. Discussions are currently underway with two prominent hospitals for this trial.
"The University of Sydney found the naturally occurring compounds on Kangaroo Island, we then completed our multiyear process of developing the synthetic processes and patenting the compound and related analogs," said Dean Becker, chairman and CEO of ROKiT Pharma and globally recognized leader in IP strategy. "Our plan is to produce large quantities of the drug - enough for universal need - so that we can really help people combat this disease through more natural sources. Unleashing nature is our goal - we want to provide these potentially life prolonging drugs, in oral pill form, at a projected cost under $1,500 per month."
The patented chemical platform of ROKiT Pharma's key drugs have unprecedented in vitro and in vivo efficacy on 29 major types of cancer (intriguingly, showing activity on p53, AP-1, and NF-kB). Importantly, selective toxicity of ROK-001 on cancer cells rather than non-neoplastic (healthy) cell lines account for its' high therapeutic index, while safety profile evaluations confirm that the compound exerts no genotoxicity nor cardiotoxicity.
Given these results, ROKiT Pharma narrowed its focus for its' first clinical trial to some of the worst cancers that have no current cure - pancreatic and brain (specifically Glioblastoma Multiforme and patients who have had metastases to the brain from other organs).
"Once ROKiT Pharma is able to get FDA approval in one adult cancer type, we plan to divert our focus to childhood cancers," said John Paul DeJoria, ROKiT co-founder and founder of Paul Mitchell Systems and Patron Tequila. "As ROKiT continues to grow globally, we are continuing to add companies that really fulfill our humanitarian goals. Success unshared is failure."
The naturally derived anticancer compounds used to create ROK-001 were discovered through the propolis of Ligurian honey bees only found on Kangaroo Island, which lies off the mainland of South Australia. Propolis is a mixture of beeswax, saps and resins.
In animal studies, ROK-001 demonstrated great efficacy in a multitude of cancer models including pancreatic, melanoma, kidney, bladder, and breast, some in as early as seven days post-oral treatment. Aside from efficacy information, ROK-001 was specifically formulated for oral delivery that not only demonstrated nice biodistribution, but it also revealed that ROK-001 can cross the blood-brain barrier in mice. This discovery led to the decision to target brain cancers.
ROKiT Pharma hopes to fast track this relatively low-toxicity drug for patients with the most deadly cancers. With any proven efficacy in the Phase 1b clinical trial, the FDA may allow an immediate Phase 2 trial to start with an expanded cohort and patient population.
Upon IND approval of ROK-001, the company plans to make the drug available for "Compassionate Use" as is now allowed under the "Right To Try Act" that President Trump signed in 2018.
ROKiT Pharma is presently designing and planning a manufacturing facility (or contract manufacturing facility) in Puerto Rico to act as an established hub for global distribution.
"As the ROKiT brand's awareness continues to grow through our global sports sponsorships - ROKiT Williams Racing Formula 1, ROKiT Venturi Racing Formula E, the Houston Rockets, the Las Vegas Raiders - we are elated to be aggressively entering the pharmaceutical marketplace," said Jonathan Kendrick, co-founder of ROKiT.
The company is optimistic that ROK-001 will move straight into at least one Phase 2 trial and is currently adding philanthropic investors to its capital base.
If there is interest in learning more about ROKiT Pharma or for philanthropic inquiries, please contact firstname.lastname@example.org for further information.
About ROKiT Pharma
ROKiT Pharma is a late stage preclinical pharma company focusing its research efforts on cancer. The corporation has an extensive global intellectual property portfolio. Research was developed at and in conjunction with the University of Sydney.
Additional information (*new site under construction Q2/2020): https://www.rokitpharma.com/
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