On October 24, 2018 SignPath Pharma Inc. reported in the October issue of "Cancer Chemotherapy and Pharmacology"*, a leading cancer journal, the final results of a Phase 1b cancer study of proprietary Liposomal Curcumin (Press release, SignPath Pharma, OCT 24, 2018, View Source [SID1234530192]). The study showed that the Liposomal Curcumin formulation (Lipocurc) can result in blood levels up to 1000 times that achieved with oral curcumin. In addition, no major toxicity was noted at these high blood levels. Specifically no toxicity was found in kidney, lung, liver and heart organs. The study involved 31 heavily pretreated cancer patients. Significant tumor marker responses and transient clinical benefit were also observed.

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Curcumin has long been of interest as an anti-inflammatory modulator and as a potential therapeutic agent for cancer, central nervous system and other diseases. Orally administered curcumin has not been able to achieve sufficient blood levels. LipoCurc addresses these limitations and has the potential to be a potent, non-toxic modality for treating these dire conditions.

Although Phase 1b studies are designed to determine safety of a drug and not to measure efficacy, two patients had obvious and important signs of tumor response. One was a 75 year old male with colon cancer, who had previously failed seven multi-drug chemotherapy combinations. On Lipocurc, his CEA, a tumor-marker which is elevated in patients with cancer, fell from above 18,000 to just above 6,000, and he showed clinical improvement. The other was a patient with prostate cancer who had previously failed radiation therapy as well as six chemotherapy combinations. His PSA level fell from 649 to 350 and he also showed clinical improvement.

On the basis of these results, SignPath is planning several phase 2 trials to test the efficacy of Lipocurc against specific cancer types. Trials are planned in patients with glioblastoma, in multiple myeloma, and in mesothelioma. Dr. Peter Sordillo, Chief Medical Officer of SignPath Pharma, states "We are very pleased with the Phase 1b results with LipoCurc and look forward to testing it in Phase 2 clinical trials. We believe LipoCurc has the potential to be a new potent, non-toxic therapeutic strategy for cancer and other diseases."

SignPath Pharma, Inc. is a clinical stage biopharmaceutical company developing two major drug platforms:

LipoCurc for cancer, neurodegenerative diseases and sepsis.
SPP 4040 for prevention of drug-induced cardiac arrhythmias, and prevention of heart damage and congestive heart failure secondary to chemotherapy.

On October 24, 2018 Privo Technologies reported that it was granted the green light from the FDA and several hospitals this summer to begin patient recruitment for a prospective clinical trial (NCT03502148) targeting early-stage oral cavity squamous cell carcinoma (OCSCC) (Press release, Privo Technologies, OCT 24, 2018, View Source [SID1234530215]). Privo is now actively recruiting stage I and II OCSCC patients for this study.

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About PRV111:

Privo’s PRV 111 (topical patch) is placed directly onto a mucosal tissue. This topical patch is intended for the locoregional treatment of oral cavity squamous cell carcinoma without systemic toxicity.
Privo’s PRV 111 (topical patch) is placed directly onto a mucosal tissue. This topical patch is intended for the locoregional treatment of oral cavity squamous cell carcinoma without systemic toxicity.
Privo has developed a nano-engineered product called PRV111 consisting of a topical patch designed to deliver and retain high concentrations of various existing systemic agents within the primary tumor and associated nodal basins.

Dr. Manijeh Goldberg, Privo’s founder, and CEO is very encouraged by the result of Privo’s preclinical studies and expects PRV111 to provide a safer and more effective treatment option to patients suffering from oral cancer.

When placed on the tumor, PRV111 releases and retains cisplatin-loaded particles into the tumor, resulting in a dramatic reduction of tumor size, without the accompanying systemic side effects of intravenous cisplatin (i.e., nephrotoxicity and neurotoxicity). Local and regional effects of PRV111 are expected to improve tumor resectability, decrease the need for post-operative radiation and chemotherapy and improve patient survival. According to the National Cancer Institute, 76% of all newly diagnosed oral cancers are locoregional (29% local and 47% regional), and the 5-year survival is about 65%. Privo aims to improve the survival rates with its PRV111 intensive topical treatment. This organ-sparing therapy can preserve oral cavity form and function while improving locoregional disease control, which is the primary driver of disease-specific and overall survival. In patients with the regional metastatic disease, PRV111 can be combined with the standard of care chemo-radiation regimens to provide improved locoregional control while maintaining a tolerable side effect profile and improving quality of life.

When asked about Privo’s clinical trial (NCT03502148), Dr. Vlad Sandulache, surgical oncologist and the clinical study’s principal investigator stated:

"We have learned much about the genomic, epigenetic and proteomic profile of oral cavity squamous cell carcinoma (OCSCC) over the last decade. Unfortunately, this knowledge has not translated into effective novel therapies or improved survival for our patients. Cisplatin, although an old drug, remains by far the most effective systemic agent available for patients with OCSCC; however systemic toxicity limits utilization and can prevent use in patients with pre-existing renal disease. PRV111 presents a unique opportunity to revolutionize utilization of this proven agent. Not only does locoregional delivery completely eliminate systemic toxicity, but the intra-tumoral cisplatin concentrations generated by PRV111exceed those achievable through intravenous administration by over an order of magnitude. This represents a qualitative leap in potential effectiveness which could overcome traditional mechanisms of cisplatin resistance previously described in OCSCC."

Clinical Trial Info

For information regarding this trial, please visit View Source

Participating hospitals include:

Baylor Clinic, 6620 Main Street, Houston, Texas 77030
Baylor St. Luke’s Medical Center, 6720 Bertner Avenue, Houston, Texas 77030
Baylor College of Medicine, 1 Baylor Plaza, Houston, Texas 77030
Houston Methodist Hospital, 6550 Fannin Street, Suite 1701, Houston, Texas 77030
Ben Taub Hospital, 1504 Ben Taub Loop, Houston, Texas 77030
Harris Health System – Smith Clinic, 2525A Holly Hall Street, Houston, Texas 77054
Memorial Hermann-Texas Medical Center, Houston, Texas 77030
The University of Cincinnati Cancer Institute, Head and Neck Cancer Center, 234 Goodman Street, Cincinnati, Ohio 45219
West Chester Hospital, 7700 University Drive, West Chester, Ohio 45069

On October 24, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Chief Executive Officer Rachel King will provide a company overview at two upcoming investor conferences, as follows (Press release, GlycoMimetics, OCT 24, 2018, View Source [SID1234530099]):

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STIFEL 2018 HEALTHCARE CONFERENCE
When: November 13, 2018 at 10:15 a.m. ET
Where: New York, NY, USA

JEFFERIES 2018 LONDON HEALTHCARE CONFERENCE
When: November 15, 2018 at 8:40 a.m. GMT
Where: London, UK

To access the live webcast and subsequent archived recordings for the presentations, please visit the GlycoMimetics website at www.glycomimetics.com.

On October 24, 2018 TP Therapeutics, a clinical-stage precision oncology company developing novel drugs that address treatment resistance, and Almac Diagnostic Services, a global precision medicine company, reported a global collaboration agreement to develop and commercialize a next-generation sequencing (NGS) companion diagnostic (CDx) for repotrectinib, TP Therapeutics’ investigational therapy rationally designed to target ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors (Press release, TP Therapeutics, OCT 24, 2018, View Source [SID1234530193]).

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Under the agreement, Almac will develop the NGS diagnostic based on the ArcherDx’s Anchored Multiplex PCR (AMP) chemistry, with the intent of submitting it for regulatory approval in the United States. The companion diagnostic will initially allow Almac’s CLIA-accredited laboratory in Durham, N.C. to identify tumors with the targeted gene fusions, enabling physicians to select appropriate patients for treatment with repotrectinib.

"Almac provides us with deep experience in the development and regulatory approval of next-generation sequencing diagnostic assays, which will enable the selection of patients who may not otherwise have access to a targeted therapy like repotrectinib," said Dr. J Jean Cui, founder, president and chief scientific officer of TP Therapeutics. "We look forward to working with Almac to co-develop repotrectinib with a next generation sequencing based companion diagnostic that detects the presence of ROS1, NTRK1-3 and ALK gene fusions."

"Molecular testing is critical to identifying patients most likely to benefit from a targeted treatment," said Paul Harkin, managing director, Almac Diagnostic Services. "We have great expertise in the development of biomarker assays across a wide range of technologies and targets, with an extensive track-record in developing and validating assays under design control and according to regulatory requirements. We are very pleased to work with TP Therapeutics on such a promising investigational therapy as repotrectinib."

Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI) developed for the treatment of patients with advanced solid tumors harboring ROS1, NTRK1-3 or ALK molecular rearrangements. Repotrectinib is a rationally designed, low molecular weight, macrocyclic TKI that is much smaller than current ROS1, TRK family and ALK inhibitors with the objective to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.

Co-development of CDx and therapeutic products is critical to the advancement of targeted therapies and precision medicine. Companion diagnostics are tests designed to confirm the presence of a specific biomarker to assist physicians in selecting effective therapies for their patients, based on the individual molecular characteristics of each person. Incorporating a companion diagnostic strategy into a drug development program may help generate more effective treatments with improved safety profiles for patients.

The financial terms of the agreement were not disclosed.

On October 24, 2018 Orion and Bayer reported that they have completed the phase III clinical trial (ARAMIS) of darolutamide, the novel oral androgen receptor antagonist for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) (Press release, Orion Pharma, OCT 24, 2018, View Source;the-primary-endpoint-was-met/ [SID1234530144]). The primary endpoint of the trial was met: Darolutamide significantly extended metastasis-free survival compared to placebo.The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were consistent with previously published data on darolutamide.

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The full data will be presented at an upcoming scientific meeting. Bayer plans to discuss the data from the ARAMIS trial with health authorities regarding the submission for marketing authorization application. As a rule, Orion will provide information on the progress of the marketing authorization application process in a press release or in its financial reports. Darolutamide has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment in men with nmCRPC.

The ARAMIS trial

Commenced in 2014, the ARAMIS trial evaluated the efficacy and safety of darolutamide in patients with non-metastatic castration-resistant prostate cancer who are currently being treated with androgen deprivation therapy (ADT) as standard of care and are at risk of developing metastatic disease. In the double-blind, placebo-controlled trial, more than 1,500 patients were randomized to receive 600 mg of darolutamide or matching placebo twice a day. The primary endpoint was metastasis-free survival, defined as time between randomization and evidence of metastasis or death from any cause.

Financial terms

Darolutamide was developed jointly by Orion and Bayer, and the partnership was announced in a stock exchange release on 2 June 2014. Bayer has covered the majority of the darolutamide development costs. According to the agreement, Bayer has the right to commercialize darolutamide globally while Orion has the option of co-promoting the product in Europe. In addition, Orion will manufacture the product for global markets.

Orion is eligible to receive milestone payments from Bayer upon first commercial sale of darolutamide as follows:

EUR 45 million upon first commercial sale in the United States
EUR 20 million upon first commercial sale in the EU
EUR 8 million upon first commercial sale in Japan

Besides milestone payments, Orion will also receive tiered royalties on the product sales, which will be approximately 20 percent, including production revenue. With sales increase, royalties may increase slightly. Orion also has the possibility to receive one-off payments from Bayer if certain sales targets are met.

In addition to the completed ARAMIS trial, Orion and Bayer have an ongoing phase III clinical trial (ARASENS) which evaluates the safety and efficacy of darolutamide in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Expected to be completed in 2022, there are no separate milestone payments related to the ARASENS trial.

"Prostate cancer is the second most commonly diagnosed malignancy in men in worldwide, and approximately 70 percent of patients have the non-metastatic form of the disease. While conventional hormone therapy is effective in the treatment of non-metastatic cancer, the efficacy is often eventually lost as the sole form of treatment. Additional treatment options in the early stages of the cancer that delay the time to metastases with a manageable safety profile are long awaited. They are significant for the patient’s overall well-being," says Christer Nordstedt, Senior Vice President, Research and Development at Orion.