On April 13, 2016 Tokai Pharmaceuticals Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, reported that two presentations on galeterone will be made during poster sessions held at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 in New Orleans (Press release, Tokai Pharmaceuticals, APR 13, 2016, View Source;p=RssLanding&cat=news&id=2156705 [SID:1234510747]). Galeterone, Tokai’s lead product candidate, is being developed for the treatment of men with metastatic castration-resistance prostate cancer.

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Title: Galeterone-induced degradation of the androgen receptor involves inhibition of deubiquitinating enzymes
Date/time: Monday, April 18, 2016, 8 a.m. – 12 p.m. CDT
Location: Section 16
Abstract: 1234
Title: The effect of novel CYP17 inhibitor galeterone on gonadal and tumor progestogen and androgen levels in SCID mice bearing LNCaP prostate cancer xenografts
Date/time: Tuesday, April 19, 2016, 1 – 5 p.m. CDT
Location: Section 1
Abstract: 3490
Additional information, including the presentation schedule and full abstracts, may be found at www.aacr.org. A copy of each presentation will be available on the "Publications & Presentations" page of Tokai’s website, www.tokaipharma.com.

About Galeterone
Galeterone is an oral small molecule that utilizes the established pathways, including CYP17 enzyme and androgen receptor inhibition, of the current second-generation hormonal therapies abiraterone and enzalutamide. Galeterone also introduces a distinct third mechanism – androgen receptor degradation – that decreases the sensitivity of androgen receptors to androgen activity, thus leading to reductions in tumor growth. Tokai is developing galeterone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). ARMOR3-SV, the company’s pivotal Phase 3 study of galeterone in treatment-naive mCRPC patients whose prostate tumors express the AR-V7 splice variant, is evaluating whether administration of galeterone results in a statistically significant increase in radiographic progression-free survival as compared to enzalutamide. Tokai is also evaluating galeterone in mCRPC patients who have shown resistance following treatment with second-generation hormonal agents. Tokai has worldwide development and commercialization rights to galeterone.

On April 13, 2016 (TG Therapeutics, Inc. (Nasdaq:TGTX) reported that the United States Patent and Trademark Office (USPTO) has issued a patent for the composition of matter of TG-1101, the Company’s novel, glycoengineered monoclonal antibody (Press release, TG Therapeutics, APR 13, 2016, View Source [SID:1234510746]). The patent, U.S. Patent No. 9,234,045 specifically covers the composition of TG-1101, and its use for treating various forms of CD20 expressing leukemia and lymphoma, including chronic lymphocytic leukemia (CLL) and various types of non-Hodgkin’s lymphoma, including follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).

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The patent was issued to LFB SA and is exclusively licensed to TG Therapeutics pursuant to the Company’s existing license agreement with LFB SA. The issuance affords patent protection for TG-1101 in the US through July of 2029, exclusive of additional patent term extensions also available. TG-1101 is currently being studied in two Phase 3 clinical trials in patients with CLL, with additional registration directed trials in NHL expected to commence in 2016.

"We are excited to announce the issuance of the first U.S. patent for TG-1101 which affords protection through 2029. With composition of matter patents now in place for both TG-1101 and TGR-1202, and an additional later-filed patent application on the combination of TG-1101 and TGR-1202, we believe we have established a very strong intellectual property position for the two components of our proprietary ‘TG-1303′ regimen that provides a very attractive exclusivity period without the risk of generic competition for many years to come," stated Michael S. Weiss, the Company’s Executive Chairman and Interim CEO. Mr. Weiss continued, "We remain focused on continuing to strengthen our intellectual property position through the issuance of additional patents for both TG-1101 and TGR-1202 individually as well as in combination here in the US and abroad."

On April 13, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and the Sarcoma Foundation of America, reported that Advaxis has been awarded the 2016 Vision of Hope Award for their efforts to advance an immunotherapy platform to fight osteosarcoma in patients (Press release, Advaxis, APR 13, 2016, View Source [SID:1234510743]).

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"The Sarcoma Foundation of America is proud to present the Vision of Hope Award to Advaxis Immunotherapies, a trailblazer in the osteosarcoma space," said Bert Thomas IV, Ph.D., Chief Executive Officer of the Sarcoma Foundation of America. "Their innovative technology gives hope to sarcoma patients in critical need of new treatments and paves the way for additional immunotherapies to offer patients a brighter future."

Advaxis is the first biotechnology company to ever receive the award for their work in the development of ADXS-HER2, an Lm Technology that has received an orphan drug designation from the FDA and EMA for treatment of osteosarcoma. In a study examining canine osteosarcoma, 18 dogs received either 2×108, 5×108, 1×109 or 3.3×109 CFU of ADXS–HER2 post-completion of surgery and adjuvant chemotherapy with 15 dogs showing an induced antigen-specific response within 6 months of immunotherapy administration. Additionally, treatment with ADXS-HER2 reduced the incidence of metastatic disease and prolonged survival relative to a historical control group with only low-grade, transient side-effects.

Osteosarcoma is the most common primary bone tumor in dogs, with more than 10,000 dogs annually diagnosed, and the most common bone cancer in children and teens. It is the third most common cancer in teens after lymphomas and brain tumors. HER2 is expressed in approximately 40 to 60 percent of pediatric and canine osteosarcomas and in pulmonary metastatic disease, providing a strong rationale for HER2 targeted immunotherapy in these cancers.

"We are honored to be chosen as a recipient of this prestigious Award from the Sarcoma Foundation of America," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "We recognize the serious unmet need to treat children and young adults battling this life-threatening disease and are proud to work towards developing immunotherapies that may help change the course of osteosarcoma patients’ lives."

Advaxis will receive the Vision of Hope Award at the Sarcoma Foundation of America 14th Annual Fundraising Event, "A Celebration of Life," on Thursday, May 12, 2016 at 6:00 PM EDT in New York City. For further information and to register, visit the Sarcoma Foundation of America’s website.

About Sarcoma

Sarcoma is a rare cancer in adults, accounting for 1 percent of all adult cancers, but rather prevalent in children, accounting for about 15 percent of all childhood cancers. At any one time, 50,000 patients and their families are struggling with sarcoma. Every year, nearly 15,000 new cases are diagnosed and about 6,000 people die from the disease.

About the Sarcoma Foundation of America

The Sarcoma Foundation of America (SFA), a 501(c)(3) nonprofit charitable organization, is an advocate for increased research to find new and better therapies with which to treat patients with sarcoma. The organization raises money to privately fund grants for sarcoma researchers and conducts education and advocacy efforts on behalf of sarcoma patients. For more information, please visit www.curesarcoma.org.

About ADXS-HER2

ADXS-HER2 is an Lm Technology immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 to Aratana Therapeutics, Inc. for animal health therapeutics. Aratana expects to receive a conditional USDA license by the end of 2016 to market and sell ADXS-HER2 for dogs with canine osteosarcoma.

On April 13, 2016 Pharmatines reported that Boehringer Ingelheim’s Giotrif has beaten AstraZeneca’s Iressa on a number of clinical measures investigated in a head-to-head study involving patients with EGFR mutation-positive advanced non-small cell lung cancer (Press release, PharmaTimes, APR 13, 2016, View Source [SID:1234510736]).

The company says data from the Phase IIb LUX-Lung 7 trial, published in The Lancet, show that Giotrif (afatinib) significantly cut the risk of lung cancer progression and treatment failure, and boosted the overall response rate versus Iressa (gefitinib), "without compromising overall health-related quality of life, safety and tolerability".
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Giotrif reduced the risk of disease progression by 27 percent compared to Iressa, and, after two years’ treatment, more than twice as many patients taking the drug were alive and progression free than those taking AZ’ drug (27 percent vs 15 percent after 18 months, and 18 percent vs 8 percent after 24 months).

In addition, Giotrif-treated patients had a significantly longer time on treatment and risk of treatment failure was reduced by 27 percent, while significantly more patients had an objective tumour response compared to Iressa (70 percent vs 56 percent), with a median duration of response of 10.1 months and 8.4 months, respectively.

Both drugs showed similar improvements in patient-reported outcome measures with no significant differences in health-related quality of life. Treatment with both was generally tolerable, leading to an equal rate of treatment-related discontinuation in both arms (6 percent). The overall frequency of serious adverse events was 44.4 percent for Giotrif and 37.1 percent for Iressa.

"The totality of the efficacy data from LUX-Lung 7 clearly differentiates the second-generation inhibitor afatinib from the first-generation inhibitor gefitinib with no significant differences observed in overall safety, tolerability and health-related quality of life between the two TKIs," noted Professor Klaus Dugi, medical director and managing director, Boehringer Ingelheim UK & Ireland. "This is really good news for patients, and it will provide clinicians with further evidence to guide treatment practice in EGFR mutated NSCLC."

Data for the co-primary endpoint of overall survival are not yet mature and will be presented in the future, BI said.

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On April 13, 2016 PharmaTimes reported that Rising levels of obesity among UK women have helped drive a 54 percent jump in womb cancer rates over the last two decades, according to new figures released by Cancer Research UK (Press release, PharmaTimes, APR 13, 2016, View Source [SID:1234510735]).

Back in the early 1990s around 19 women in every 100,000 developed the disease, but that has now risen to 29 women in every 100,000, with obesity being the most likely driving force behind the increase, according to the charity.
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UK womb cancer rates highest in 30 years

In the UK around 9,000 women are now diagnosed with womb cancer every year, and around 2,000 die from the disease, a marked difference from the 4,800 annual new cases and 1,500 deaths recorded twenty years ago.

"It’s worrying that womb cancer cases are going up so sharply," said Professor Jonathan Ledermann, director of the Cancer Research UK and UCL Cancer Trials Centre. "We don’t know all the reasons why. But we do know that about a third of cases are linked to being overweight so it’s no surprise to see the increases in womb cancer cases echo rising obesity levels."

On the plus side, the figures also show that survival is improving. "In the 1970s, almost six in 10 women diagnosed with the disease survived for at least 10 years. Now almost eight in 10 women survive," said Prof Lederman. "But we need more research to understand the biology of the disease better and to know more about how it is caused so that we can improve the treatment of these women as well as preventing more cases."

Why extra weight can cause cancer is not entirely clear, but there is evidence to show that extra fat in the body can increase the risk by producing hormones and growth factors that promote cell division, the charity noted.

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