SOURCE: Cellceutix

January 20, 2015 07:00 ET

Cellceutix Reports Spleen Lesion 'Disappears' in Patient With Metastatic Stage 4 Ovarian Cancer in Clinical Trial of Anti-Cancer Drug Kevetrin

Ovarian Cancer Response -- Potential Major Breakthrough in Oncology

BEVERLY, MA--(Marketwired - Jan 20, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to report the near complete disappearance of a metastatic lesion in the spleen of a Stage 4 ovarian cancer patient who was enrolled in the Company's Phase 1 clinical trial of anti-cancer drug candidate Kevetrin™ being conducted at Harvard Cancer Center's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. According to information supplied by the hospital, the patient, who successfully completed three Kevetrin 3-dose cycles before discontinuing the trial, experienced increased energy, while scans showed a reduction in the amount of peritoneal fluid (ascites) during treatment with Kevetrin. Subsequent to the second and third Kevetrin cycles, scans showed the spleen lesion to be essentially undetectable and the patient's disease to be clinically stable. 

With the completion of the ninth cohort, and commencement of tenth cohort at 450 mg/m2, the hospital has continued research to determine the effect of Kevetrin on p21, the key biomarker tightly controlled by the tumor suppressor protein p53. p53 is often referred to as the "Guardian Angel Gene" because of its crucial role in controlling cell mutations. In nearly all cancers, p53 is deficient or mutated, thus failing to perform its role as a master cell regulator, which exacerbates tumor progression and metastasis. As such, a drug to reactivate p53 to its normal state is a prime target for a next generation cancer therapy. Because p21 is a recognized downstream target of activated p53, increased levels of p21 in peripheral blood cells suggest that Kevetrin is having an impact on returning p53 to its effectiveness as a tumor suppressor.

Research conducted by the hospital evaluating p21 expression in earlier cohorts, for which the level of exposure to Kevetrin was substantially lower, showed that about 50 percent of the patients demonstrated at least a 10% increase in p21. The data supported the hypothesis that enhanced p21 is dose related, meaning that as the amount of Kevetrin increased, so did the p21 expression. Hospital scientists are now running samples examining the effect of Kevetrin on p21 at higher dosing levels in more recent cohorts and Cellceutix hopes to disclose the results shortly.

Additionally, the Principal Investigators for the Kevetrin trial have requested that the Company start preparing a presentation to be used for an article on the safety and pharmacological effect of Kevetrin on multiple cancer lines as demonstrated in the clinical trial. Cellceutix interprets this recommendation as a very optimistic sign regarding anticipated outcomes for the trial and clinical advancement of Kevetrin.

"I can't overexpress the excitement at Cellceutix regarding Kevetrin or the significance of a metastatic lesion disappearing in a late-stage ovarian cancer patient," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "We don't know of any other company, regardless of specialization, albeit small molecule, immunotherapy or other, that has published an effect like that in such a hard-to-treat disease like metastatic ovarian cancer during a Phase 1 safety trial. The idea that a stage 4 ovarian cancer patient's disease was clinically stabilized, although her CA-125 count was increased in the third month, is remarkable. The patients in our trial are incredibly sick, have often run the gamut of approved treatments and subject to constant therapy modification to address the greatest area of need at the given moment. That's an everyday practice in oncology, especially when a drug regimen, such as the strict protocol with the Kevetrin trial where dosing levels and intervals absolutely cannot be changed. We are not privy to the minutiae underscoring any physician's decisions in a trial, but we interpret the stabilization of the cancer as allotting the physician an opportunity to modify treatment to improve the patient's quality of life, an opportunity that potentially may have not been there without Kevetrin. With that in mind, we are analyzing the collective preliminary data from the trial to date showing a strong safety profile for Kevetrin, an effect on p53 and data seeming to indicate that ovarian, pancreatic and other FDA designated orphan cancers would be ideal mid-stage clinical trial targets as we plan to move forward. Considering what has been shown recently in the Kevetrin trial and the recently completed Phase 2b trial of Brilacidin for ABSSSI, we believe that we have an incredibly strong franchise headlined by one of the most promising cancer drugs and one of the best antibiotics in development today."

About Kevetrin:
As a completely new class of chemistry in medicine, Kevetrin has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin's unique ability to affect both wild and mutant types of p53 (often referred to as the "Guardian Angel Gene" or the "Guardian Angel of the Human Genome") and that Kevetrin strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP. Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.

In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein's protective function, which Kevetrin appears to be doing the majority of the time.

The clinical trial titled, "A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors," is available at: http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1

About Ovarian Cancer:
Ovarian cancer is the most lethal of the gynecologic cancers, representing the ninth most common cancer among women and the fifth leading cause of cancer related death among women. It most commonly occurs in postmenopausal women. Ninety per cent of ovarian cancers are derived from the ovarian surface epithelium and these neoplasm are classified into serous, mucinous, endometrioid, clear-cell and transitional-cell types. The molecular pathology of ovarian carcinomas is heterogeneous and involves various putative precursor lesions and multiple pathways of development. The most common subtype, high-grade serous carcinoma, is characterized by p53 mutations, and BRCA1 and/or BRCA2 dysfunction.

About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix will soon begin a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol has recently completed a Phase 1 clinical trial and is being readied for a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.

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Forward-Looking Statements
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Contact Information

  • INVESTOR AND MEDIA CONTACT:
    Cellceutix Corporation
    Leo Ehrlich
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