Author: [email protected]

Nymox Announces $850,000 Financing

On June 16, 2015 Nymox Pharmaceutical reported that it has recently completed financing for a total of $850,000 at prices of $1.25-$1.66 (Press release, Nymox, JUN 16, 2015, View Source;fvtc=4&fvtv=6907 [SID:1234505443]). The financing consisted of a private placement of 400,000 shares with a European investor at $1.25 per share and an equity line drawdown from the Company’s existing facility consisting of 217,122 shares priced at $1.66 per share. There were no warrants attached to the transactions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company’s lead product NX-1207 is in Phase 3 development for benign prostatic hyperplasia (BPH). Nymox recently announced that the Company is conducting Phase 3 NX-1207 BPH pivotal studies long-term follow-up extension data capture that is expected to be completed and results reported in late Q2 or early Q3 2015.

Nymox has also recently reported a successful Phase 2 long-term outcome study in 147 men of NX-1207 at higher dosage for low grade localized prostate cancer.

BPH is one of the most commonly diagnosed diseases in middle aged and older men. The condition has negative impacts on men’s health and quality of life and often leads to need for surgery. It is estimated that 50% of men in their 50’s have pathological signs of prostatic hyperplasia and one quarter to one half of men over 40 suffer from moderate to severe urinary symptoms associated with BPH.

The American Cancer Society estimates that in 2012 more than 240,000 men in the United States will be newly diagnosed with prostate cancer and more than 28,000 men will die from the disease. Most cases are detected via prostate-specific antigen (PSA) screening and usually found to have localized tumors. Surgical removal of the prostate (radical prostatectomy) and radiation therapy with or without androgen deprivation therapy are the most common active treatment options for localized prostate cancer but have significant short and long-term adverse effects, including impotence, urinary dysfunction, and other complications.

– See more at: View Source;fvtc=4&fvtv=6907#sthash.gnhqulFg.dpuf

8-K – Current report

On June 16, 2015 Provectus Biopharmaceuticals reported that the Society of Surgical Oncology (SSO) has published an abstract describing preliminary research into use of the Company’s investigational agent, PV-10, in murine models of colon cancer (Filing, 8-K, Provectus Pharmaceuticals, JUN 16, 2015, View Source [SID:1234505440]). A poster based on the published abstract was presented at the SSO’s 68th Annual Cancer Symposium.
Titled, "Intralesional Injection of Rose Bengal Induces an Anti-tumor Immune Response and Potent Tumor Regressions in a Murine Model of Colon Cancer," the abstract detailed research by K. Pardiwala, G. Qiao, J. Sundararajan, B. Prabhakar, and A.V. Maker at the University of Illinois at Chicago, Chicago, IL.
Based on their findings, the researchers concluded, "Rose Bengal induced potent cell death in human and murine colon cancer cells in vitro. Intralesional injection in established tumors induced an anti-tumor immune response and significant tumor regressions in vivo. These studies establish that intralesional PV-10 therapy warrants further study as a potential immunotherapeutic agent in colorectal cancer and metastases."
The SSO has made available all the abstracts from the Symposium in an electronic supplement to Annals of Surgical Oncology, its house journal. The abstract on PV-10 can be found on page S86 of the book, View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


OncoSec Medical Enrolls First Patient in Squamous Cell Carcinoma of the Head and Neck Phase II Clinical Trial

On June 16, 2015 OncoSec Medical reported that the company has enrolled the first patient into OMS-I130, a Phase II clinical trial of ImmunoPulse IL-12 in patients with treatment-refractory, metastatic and unresectable squamous cell carcinoma of the head and neck (HNSCC) (Press release, OncoSec Medical, JUN 16, 2015, View Source [SID:1234505441]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ImmunoPulse IL-12, which employs intratumoral electroporation to enhance delivery of DNA-based interleukin-12 (IL-12), is designed to promote an anti-tumor immune response.

"This study will address one of the great unmet medical needs in oncology today: the number of patients who do not respond to anti-PD-1 treatment," said Mai H. Le, MD, Chief Medical Officer of OncoSec. "As we expand the application of ImmunoPulse IL-12 beyond cutaneous cancer indications, we anticipate that it will augment the anti-tumor immune response in HNSCC and increase the number of patients who will respond to anti-PD-1 therapy."

Robert H. Pierce, MD, Chief Scientific Officer of Oncosec and a member of the anti-PD-1 Biomarker Team while at Merck, added, "Key biomarker data was recently presented at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, showing that a specific NanoString-based gene expression profile characterizes anti-PD-1 response in HNSCC. Importantly, at OncoSec, we have observed the ability of ImmunoPulse IL-12 to promote this NanoString gene expression signature in melanoma, and we anticipate that this will be observed in HNSCC as well."

The lead investigators for OMS-I130 are Tanguy Seiwert, MD, from the University of Chicago and lead author of the presentation outlining the key gene signature for anti-PD-1 responders with HNSCC, and Alain Algazi, MD, from the University of California, San Francisco.

"Median overall survival in recurrent and metastatic HNSCC is less than one year even with aggressive, multi-agent chemotherapy. Immune checkpoint inhibitors, including anti-PD-1 antibodies, can achieve durable remissions in some patients, but these therapies are ineffective in the majority of patients because tumor-fighting immune cells and signals are missing from the tumor," said Dr. Algazi. "ImmunoPulse IL-12 allows tumors to produce key immune signals and attract these immune cells, which can potentially provide the missing link that will allow the majority of patients to achieve long-term remission."

OMS-I130 is a single-arm, open-label study evaluating the safety and anti-tumor activity of intratumoral DNA-based IL-12 with electroporation in approximately 30 patients with treatment-refractory metastatic and unresectable HNSCC. The key endpoints include: objective response evaluations by RECIST v1.1 and immune-related Response Criteria (irRC); biomarker comparisons of pre- and post-treatment tumor biopsies, including NanoString gene expression profiling and immunohistochemistry for tumor-infiltrating lymphocytes (TILs); duration of response to treatment; overall survival; progression-free survival; and safety.

To learn more about the trial, visit www.oncosec.com. Additional details can also be found at www.clinicaltrials.gov.

About Squamous Cell Carcinoma of the Head and Neck
Squamous cell carcinoma (SCC) of the head and neck is one of most common causes of cancer-associated mortality worldwide. While the incidence of SCC of the head and neck (HNSCC) that is attributable to traditional risk factors, smoking and alcohol abuse, is declining, the incidence of SCC of the oropharynx due to HPV infection is on the rise.1

HNSCC can be treated with surgery, radiation, or chemoradiation in 60-90 percent of patients, but a substantial number of patients will develop recurrent or distant metastatic disease after locoregional therapy. These recurrences are associated with a poor overall prognosis2, and the median overall survival in patients with metastatic HNSCC is under a year even with intensive combination chemotherapy.3

The limited efficacy of standard of care treatment options means that 11,500 patients die every year from squamous cell carcinoma of the oral cavity and the oropharynx in the United States alone.1 There is a clear medical need in head and neck cancers for more effective treatment options to minimize toxicity and improve efficacy.

Taiho Pharmaceutical Co., Ltd. and Servier Enter Into License Agreement for Development and Commercialization of Oral Anticancer Drug TAS-102 in Europe

On June 15, 2015 Taiho Pharmaceutical Co., Ltd. (Japan) and Servier (France) reported on June 15 that they have entered into an exclusive license agreement on June 12, 2015 for the development and commercialization of TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride) in Europe and other countries (Press release, Servier, JUN 15, 2015, View Source [SID1234529066]). Taiho Pharmaceutical Co., Ltd. retains the right to develop and commercialize TAS-102 in the United States, Canada, Mexico and Japan/Asia and to manufacture and supply the product. TAS-102 is an oral combination anticancer drug initially developed by Taiho Pharmaceutical Co., Ltd. for use in the treatment of refractory metastatic colorectal cancer (mCRC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under this agreement, Taiho Pharmaceutical Co., Ltd. will receive a total of US$ 130 million in an upfront payment and for MAA approval in the EU. In addition, Taiho will receive further regulatory and sales event milestone payments and royalties based on net sales. Taiho and Servier will also collaborate on the further global development of TAS-102 sharing effort and cost on an equal basis.

TAS-102 is currently under review by Health Authorities in Europe and the United States and in 2014 was approved for marketing in Japan. In the United States, Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd., will market TAS-102.

"We are very pleased to enter into this agreement for TAS-102 with Servier who has a strong presence around the world especially in Europe as a research-based pharmaceutical company and has made a long term commitment to oncology," said Masayuki Kobayashi, President and Representative Director of Taiho Pharmaceutical Co., Ltd. "Taiho and Servier will work vigorously in close cooperation to accelerate development and commercialization of TAS-102 and make it available to patients globally."

"This partnership with Taiho will hopefully allow us to rapidly bring a new therapeutic option to patients suffering from refractory metastatic colorectal cancer in Europe and other countries," said Olivier Laureau, President of Servier. "We respect and value Taiho’s well-known expertise in the development of oral cancer drugs and hence this collaboration will contribute to develop Servier’s capabilities in oncology. Such a landmark agreement confirms Servier’s strong ambition in oncology and our willingness to bring to cancer patients new therapeutic solutions through Servier’s extensive portfolio of innovative treatments currently in clinical development. This is in line with our commitment to therapeutic progress for the benefit of patients."

Taiho Pharmaceutical Co., Ltd. and Servier anticipate that TAS-102, as a new treatment option, will make an even greater contribution to cancer patients in Europe and other countries through their partnership.

About TAS-102

TAS-102 is an oral combination anticancer drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase. TAS-102 is commercially available in Japan and is under regulatory review in the United States of America and the European Union for the treatment of refractory metastatic colorectal cancer.

About Refractory Metastatic Colorectal Cancer

There are no definitive data on the number of patients who are refractory to standard metastatic colorectal cancer treatments; however, colorectal cancer is one of the most common cancers in the European Union (i) and the third most common cancer worldwide (ii). In 2013, a study published in the European Journal of Cancer revealed that an estimated 447,000 patients (242,000 men and 205,000 women) were diagnosed with and 215,000 patients died of colorectal cancer in Europe in 2012 (i). In addition, the American Cancer Society estimated that 136,830 patients (71,830 men and 65,000 women) were diagnosed with and 50,310 patients died of cancer of the colon and rectum in the United States in 2014 (iii).

Notes:

(i) Ferlay, J. et. al. Cancer incidence and mortality patterns in Europe:
Estimates for 40 countries in 2012.European Journal of Cancer. (2013)
49; 1374-1403

(ii) World Cancer Research Fund International. Worldwide Data. 2013.
View Source
Accessed February 2015.
GLOBOCAN 2012 Estimated Cancer Incidence, Mortality and Prevalence
Worldwide in 2012.

(iii) Cancer facts & figures 2014. American Cancer Society.

Subgroup Analyses of a Phase 3 Study in Patients with Myelodysplastic Syndromes Failing HMA Treatment: Identification of a Homogeneous Population Who Benefit from Rigosertib Therapy

In-depth analysis of ONTIME, and found that patients with the worst prognosis at entry, and thus with the greatest unmet medical need, appeared to benefit most from rigosertib treatment; namely, those with Primary AZA Failure, Very High Risk (VHR)-Revised International Prognostic Scoring System (IPSS-R), and monosomy 7 (Poster, Onconova, JUN 15, 2015, View Source;fileid=835336&filekey=758FA9A5-D91E-46AA-BC88-6A3B6C7CC728&filename=Gaidano_EHA_2015_ONTIME_subgroups.pdf [SID:1234507264]). The analyzed duration of prior hypomethylating agent (HMA) treatment inversely correlated with survival benefit.
Based on these results, a new randomized prospective controlled study in this high-risk MDS patient population comparing rigosertib to physician’s choice will be conducted to confirm these important observations.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!