Listen to The Groundwork Forum Podcast Interview of Kyle Guse CFO of Atossa Titled “An Overview of Breast Cancer Treatment Innovator Atossa Genetics”

The Groundwork Forum Podcast aims to bring together leaders from all disciplines all over the world to join its Global Community to consider new perspectives on key issues; to create a powerful, global network in order to strengthen the influence throughout the world; to draw up innovative and concrete action plans to encourage contribution to society; and to promote diversity in the business world.

The most recent Groundwork Forum Podcast Episode features an interview with Seattle-based Atossa Genetic’s CFO Kyle Guse and is titled “An Overview of Breast Cancer Treatment Innovator Atossa Genetics.” Atossa Genetics Inc. (NasdaqCM: ATOS) is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions.

To listen to the podcast, visit https://www.vistapglobal.com/groundwork-forum/.

Fans of the podcast can contact inquiries@vistapglobal.com via email or provide feedback and ideas for the podcast.

Based in San Francisco the Groundwork Forum is hosted by John Heerdink, Managing Director of Vista Partners LLC. The Groundwork Forum is released periodically and is available for free at https://www.vistapglobal.com/groundwork-forum/.

Founded in 2005, Vista Partners LLC (“Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, The Groundwork Forum Podcast and Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Pfizer & Eli Lilly Announce Positive Results in OA Pain Treatment Trial

Pfizer (PFE)  is a leading global provider of anti-infective medicines, offering patients access to a diverse portfolio of more than 80 products.

Pfizer and Eli Lilly have announced that their 16-week Phase 3 study in patients with osteoarthritis pain evaluating subcutaneous administration of tanezumab has met all three of the co-primary endpoints. The study showed that patients receiving two doses of the tanezumab separated by eights weeks showed is statistically greater improvement in the categories of pain, physical function, and individual overall assessment of their osteoarthritis when compared to those patients who received the placebo.

Tanezumab belongs to a class of pain medications labeled as nerve growth factor (NGF) inhibitors that is currently classified as investigational. Along with its evaluation for osteoarthritis pain, the medication is also being tested for chronic low back pain and cancer pain.

The preliminary safety data for tanezumab reported that the drug was generally well tolerated. Only approximately 1% of patients discontinued the treatment because of adverse events. A frequency of less than 1.5% of rapidly progressive osteoarthritis was observed in patients treated with tanezumab. There were no cases of osteonecrosis in the trial and no new safety signals were identified.

The U.S. Food and Drug Administration granted Fast Track designation for tanezumab to treat osteoarthritis pain and CLBP in June of 2017. The treatment will be the first NGF inhibitor to be given Fast Track designation which is a process that is designed to aid the development and accelerate the review of new therapies that treat serious conditions and also fill unmet medical needs.

To learn more about Pfizer (PFE) and to track its progress please visit the Vista Partners Pfizer Coverage Page.

Two Green Leaves

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Pfizer And Lilly Announce Positive Top-Line Results From Phase 3 Trial Of Tanezumab For The Treatment Of Osteoarthritis (OA) Pain

Pfizer Inc.(PFE) and Eli Lilly and Company (LLY) today announced that a 16-week Phase 3 study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. The study demonstrated..

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Dow 30 Component Johnson & Johnson Surpasses Q2 Earnings Estimates

Dow 30 component Johnson & Johnson (JNJ) is a worldwide healthcare focused company that embraces research and science so that it can provide customers with innovative ideas, products, and services.

Johnson & Johnson reported earnings of $2.10 on July 27, 2018 before the market open for Q2 2018. The earnings beat the estimates of $2.083 per share.

The company reported $20.8 billion in sales which is a 10.6% increase when compared to Q2 2017. Johnson & Johnson’s net earnings and diluted earnings per share were $4.0 billion and $1.45.

The sales guidance for the full-year 2018 was updated to $80.5 – $81.3 billion, reflecting an increase in the expected operational growth range of 4.5% to 5.5%.

Alex Gorsky, Chairman and Chief Executive Officer stated, “Our strong second-quarter results reflect double-digit growth in our Pharmaceutical business and the accelerating sales momentum in our Medical Devices business, driven by the continued growth of our market leading products and strategic new launches. We remain focused on investing in innovation and meeting the needs of our customers by delivering innovative products and solutions that position the company to deliver long-term, sustainable growth. Our talented J&J colleagues are united in our efforts to address some of the most critical health and consumer needs of people around the world.”

A more detailed report of the Johnson & Johnson second quarter financial results can be found here.

To learn more about Johnson & Johnson (JNJ) and to continue to track its progress visit the Vista Partners Johnson & Johnson Coverage Page.

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Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.
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Johnson & Johnson Reports 2018 Second-Quarter Results:

NEW BRUNSWICK, N.J., July 17, 2018 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) today announced sales of $20.8 billion for the second quarter of 2018, an increase of 10.6% as compared to the second quarter of 2017. Operational sales results increased 8.7% and the positive impact of currency was 1.9%. Dom…..

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Walgreens Receives Top Marks on DEI Survey

Walgreen Boots Alliance (WBA), a recent addition to the Dow 30, is a pharmacy-led, health and wellbeing enterprise with a long history of trusted healthcare services, community pharmacy care, and pharmaceutical wholesaling dates.

Global pharmacy Walgreens received a perfect score for the second consecutive year on the 2018 Disability Equality Index or DEI, making it one of the DEI Best Places to Work for Disability Inclusion. The DEI is a national survey and report administered by the American Association of People with Disabilities and the U.S. Business Leadership Network that benchmarks corporate policies and practices related to workplace equality and disability inclusion.

Walgreen is among 126 U.S. businesses to earn the distinction of being a DEI Best Place to Work for Disability Inclusion.

A complete list of the top companies on the 2018 Disability Equality Index can be found here.

To learn more about Walgreen Boots Alliance (WBA) and to continue to track its progress please visit the Vista Partners Walgreens Boots Alliance Page.

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Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Walgreens Earns Best Place to Work for Disability Equality in 2018 Disability Equality Index

Walgreens received the top-score of 100 percent on the 2018 Disability Equality Index® (DEI), a national benchmarking survey and report on corporate policies and practices related to disability inclusion and workplace equality, administered by the American Association of People with Disabilities..

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Why Is Pfizer Reorganizing Into Three Businesses?

Pfizer (PFE)  is a leading global provider of anti-infective medicines, offering patients access to a diverse portfolio of more than 80 products.

Pfizer Inc. is set to organize the company into three businesses. The first, a science-based Innovative Medicines business that will also include biosimilars; the second, a new hospital business unit that will be used for anti-infectives and sterile injectables; and the third, an Established Medicines business for off-patent branded and generic medicines that will operate with substantial autonomy within the Pfizer and Consumer Healthcare business. Pfizer’s new changes will go into effect at the beginning of the 2019 fiscal year.

All of the current Pfizer Innovative Health business units and the new Hospital Medicines business unit will be included in the new Innovative Medicines business. With an aging population that is causing an increasing demand for new and innovative medicines as well as quickly advancing biological science that is quickly delivering progressive solutions, the growth fundamentals for the Innovative Medicines business are far from weak.

The majority of Pfizer’s off-patent solid oral dose legacy brands that include Lyrica, Lipitor, Norvasc, Viagra, and certain generic medicines will be included in the Established Medicines business which will conduct business in all regions of the world. The new business will feature distinct and fully-dedicated manufacturing and marketing that will allow it to act with both speed and flexibility and operate as a truly independent business within Pfizer.

After the impact of the loss of exclusivity of legacy brand Lyrica in the United States after December 2018, the company foresees the Established Medicines business has the promise to create sustainable modest revenue growth. The urbanization and rise of the middle class in emerging markets such as Asia will provide additional entry opportunities and significant demand for branded and generic established medicines. Pfizer trusts that as a leading pharmaceutical company in Asia, that it is in prime position to become a leader in this rapidly growing market.

The Consumer Healthcare or PCH business will consist of all of Pfizer’s over-the-counter medicines and will carry on operations fairly autonomously with its dedicated manufacturing and regulatory capabilities.

The new changes to Pfizer’s organizational structure should not impact its capital allocation priorities or Full-Year 2018 financial guidance. Financial reports reflecting the reorganization for Pfizer will begin with the first quarter 2019 earnings.

Pfizer’s Innovative Medicines business will be led by John Young and Angela Hwang who will continue reporting to Albert Bourla.

Micheal Goettler will lead the Established Medicines business and report to Albert Bourla.

To learn more about Pfizer (PFE) and to track its progress please visit the Vista Partners Pfizer Coverage Page.

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Pfizer to Organize for Future Growth

New Hospital Business unit created within Innovative Medicines to focus on significant role of hospitals in healthcare systems..

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Atossa Genetics Opens Phase 2 Study Oral Endoxifen To Treat Breast Cancer In The “Window of Opportunity” Setting

Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an FDA-approved drug to prevent new breast cancer as well as recurrent breast cancer in breast cancer patients. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. Up to half of the patients taking tamoxifen, however, do not produce therapeutic levels of Endoxifen, frequently because of metabolism problems. Tamoxifen also has some very rare but serious adverse side effects, which can include stroke, blood clots, pulmonary embolism, blindness, and endometrial cancer. Because of these drawbacks of Tamoxifen, Seattle based Atossa Genetics Inc. (Nasdaq: ATOS) is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. is developing oral and topical forms of Endoxifen.

Friday saw Atossa announce that it has opened a Phase 2 study of its proprietary oral Endoxifen to treat breast cancer in the “window of opportunity” setting, which is the period between diagnosis of breast cancer and surgery. 

The Pilot Phase of the study will initially enroll up to eight newly-diagnosed patients with Estrogen Receptor Positive (ER+) and HER2 negative (HER2-) stage 1 or 2 invasive breast cancer, requiring mastectomy or lumpectomy. Patients will receive Atossa’s proprietary oral Endoxifen for at least 21 days from the time of diagnosis up to the day of surgery. Provided tumor activity reduction is demonstrated in at least two patients, an additional 17 patients will be enrolled for a total of 25. The U.S. FDA has provided a guidance document on “window of opportunity” or neoadjuvant studies entitled “Guidance for Industry Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval.” URL: https://www.fda.gov/downloads/drugs/guidances/ucm305501.pdf. The Company is using this document to inform this study and its design.

The primary endpoint is to determine if the administration of oral Endoxifen reduces the tumor activity as measured by Ki-67, which is a marker of cellular proliferation. The secondary endpoints are safety and tolerability and assessment of the study drug on expression levels of both estrogen and progesterone receptors. The impact on additional markers of cellular activity will also be explored.

The Phase 2 study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia. CPR Pharma recently completed the successful Phase 1 study of Atossa’s oral and topical Endoxifen in women.

Steve Quay, Ph.D., MD, President and CEO of Atossa stated, “Once a patient is diagnosed with breast cancer, there is a window of time, typically a number of weeks, before definitive surgery is performed. Our goal with this study is to show that our proprietary oral Endoxifen can modify the cancer activity in estrogen-receptor-positive patients during this ‘window of opportunity.’ Tamoxifen, the current standard of care, has not been effective in this setting, probably because it can take 50-200 days to reach steady-state of Endoxifen blood levels, while the surgery is usually completed within 30 to 45 days of diagnosis. Because our Phase 1 study indicated that our oral Endoxifen reaches therapeutic levels within 8 hours and therapeutic steady-state levels in only seven days, we are optimistic we can achieve a valuable treatment effect.”

A summary of Atossa’s current Endoxifen clinical pipeline is as follows:

  • Phase 2 study of oral Endoxifen to treat stage 1 or 2 breast cancer that is ER+ and HER2- in the “window of opportunity” setting: now open
  • Phase 2 study of topical Endoxifen to treat mammographic breast density: opened in June 2018
  • Phase 1 study of topical Endoxifen to treat gynecomastia in men: dosing and clinical visits completed; preliminary data to be reported in Q3 2018
  • Phase 2 study of topical Endoxifen to treat gynecomastia in men: subject to Phase 1 results, the Phase 2 is anticipated to commence in Q4 2018
  • Phase 2 study of oral Endoxifen to treat breast cancer survivors who are refractory to tamoxifen: anticipated to commence in 2H 2018
    Atossa’s Proprietary Endoxifen

Atossa has completed a comprehensive Phase 1 clinical study using both its topical and an oral formulation of Endoxifen. Results from the Phase 1 study indicated that there were no clinically significant safety signals and no clinically significant adverse events and both the oral and topical Endoxifen were well tolerated. In the topical arm of the study, low but measurable Endoxifen levels were detected in the blood in a dose-dependent fashion. In the oral arm of the study, participants exhibited dose-dependent Endoxifen levels that met or exceeded the published therapeutic level. The median time for patients in the study to reach the steady-state serum levels of Endoxifen while taking daily doses of Atossa’s oral Endoxifen was 7 days. Published literature indicates that it takes approximately 50-200 days for patients to reach steady-state Endoxifen levels when taking daily doses of oral tamoxifen.

Oral Endoxifen Opportunities

In addition to the window of opportunity setting, Atossa is also developing our proprietary oral Endoxifen for breast cancer patients who are refractory to Tamoxifen. Approximately one million breast cancer patients take Tamoxifen to prevent recurrent and new breast cancer; however, up to 50% of those patients are refractory to Tamoxifen, meaning they do not produce therapeutic levels of Endoxifen. This is often because the Tamoxifen is not properly metabolized into Endoxifen. “We believe our oral Endoxifen may provide an effective treatment supplement or option for these refractory patients because Endoxifen, unlike Tamoxifen, does not require liver metabolism,” stated Steve Quay.

Topical Endoxifen Opportunities

Atossa is developing its proprietary topical Endoxifen to reduce MBD, which has been shown in studies conducted by others to be an independent risk factor for developing breast cancer. To date, 34 U.S. states have enacted laws requiring that findings of MBD be communicated to the patient. According to the National Cancer Institute, approximately 10 million women in the U.S. have high breast density (BI-RAD level C or D with “D” being the highest). Although oral Tamoxifen has been shown to reduce MBD, the benefit-risk ratio is generally not acceptable to most patients. For example, it is estimated that only ~ 2% of women at high-risk of developing breast cancer, including those with MBD, take oral Tamoxifen to prevent breast cancer because of the risks of, or actual side-effects of oral Tamoxifen. There is no FDA-approved treatment for MBD.

In June 2018, Atossa opened a Phase 2 double-blinded placebo-controlled study of topical Endoxifen to treat MBD. The study is being conducted at Stockholm South General Hospital in Sweden by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. The primary endpoint is MBD reduction, as well as safety and tolerability. The study includes 90 participants: 30 on each of two different doses of topical Endoxifen and 30 on placebo.

Atossa is also developing topical Endoxifen for a condition in men called gynecomastia, which is male breast enlargement, and according to the Mayo Clinic affects 25% of men in the U.S. between the ages of 50-69, or approximately 10 million men. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen. In prostate cancer treatment, testosterone is suppressed with androgen deprivation therapy resulting is higher estrogen levels that usually triggers gynecomastia. One recent study indicates that up to 90% of men taking androgen deprivation therapy suffer from gynecomastia and breast pain (Handoo Rhee, et al., October 18, 2014, BJU International). There is no FDA-approved pharmaceutical to treat gynecomastia. Current therapeutic approaches in these patients include the daily use of oral estrogen-suppressing medications and prophylactic breast bud irradiation which is often repeated.

Atossa has completed dosing and clinical visits in a Phase 1 study in men using topical Endoxifen and it plans to announce preliminary results from this study in the third quarter 2018. The objectives of the placebo-controlled, repeat dose study of 24 healthy male volunteers are to assess the pharmacokinetics of a proprietary topical Endoxifen dosage form over 28 days, as well as to assess safety and tolerability.

Analyst Update

Maxim Group’s Biotechnology Analyst Jason McCarthy issued an update report recently and maintained his “Buy rating” and his $10/price target.

Learn More

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Roche Completes Acquisition of Cancer Data Company Foundation Medicine

Swiss pharma giant, Roche, bought the rest of Foundation Medicine for $2.4 billion on Tuesday. Foundation Medicine is a company that collects genetic data from samples of cancer tissue or blood. Roche already held a majority stake in Foundation Medicine, making the deal value at $5.3 billion. The deal comes as a 29% premium to where Foundation Medicine’s stock closed on Monday.

This deal is Roche’s second cancer-data related purchase of 2018. The company bought Flatiron Health, a healthcare technology startup out of New York that collects clinical data from cancer patients, for $1.9 billion earlier this year.

Foundation Medicine also works with pharmaceutical companies in creating tests that have the potential to better predict if a person would respond to a certain cancer treatment called immunotherapy.

Foundation Medicine will continue operating independently as part of the deal with Roche.

Troy Cox, Foundation CEO stated, “Joining forces with Roche as an independent operating company allows Foundation Medicine to continue its collaboration with Roche, as well as our biopharma partners, to drive ubiquitous access to CGP testing and innovative data services.”

Woman Wearing Sunglasses and Alice Band

Another company working on innovations for the treatment of breast cancer is Seattle based Atossa Genetics (NasdaqCM: ATOS). Recently, Atossa announced that it has opened its Phase 2 study of proprietary topical Endoxifen on mammographic breast density, or MBD, reduction. Studies by others have shown that a reduction in MBD reduces the risk of developing breast cancer and may potentially improve the accuracy of mammography in finding cancer.

The Phase 2 study is being conducted at Stockholm South General Hospital in Sweden and is being led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.

“Opening our first Phase 2 study using our proprietary topical Endoxifen marks a major milestone in our clinical development,” commented Steve Quay, Ph.D., MD, President and CEO of Atossa. “We look forward to working with Dr. Hall and his clinic to enroll women in this ground-breaking study and to move our topical Endoxifen a step closer to treating women with MBD. We are also making progress with our proprietary oral Endoxifen and have been evaluating a potential new indication in the pre-surgery, or “window of opportunity,” setting which involves treating newly diagnosed breast cancer patients prior to surgery. We believe this indication could have a quicker clinical and regulatory pathway. We plan to start a Phase 2 study in the next quarter in this window of opportunity setting and/or a Phase 2 study in breast cancer survivors who are “refractory” to tamoxifen,” added Dr. Quay.

The primary endpoint is to determine if topical Endoxifen administration results in an individual change in MBD, which will be measured after three and six months of entering the study. The secondary endpoints are safety and tolerability. Ninety participants will be randomized to one of three groups (one placebo group and two groups of different strengths of topical Endoxifen) with 30 participants per group. The objective of the study is to determine if MBD is reduced, and if so, the results will drive sample size calculations for a future Phase III study. Enrollment is anticipated to be completed by the end of 2018.

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

 

 

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Pharma giant Roche just made a $2.4 billion bet on cancer data

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New Combination Treatment Shows Encouraging Developments For Triple Negative Breast Cancer Patients

Approximately 12% of breast cancers diagnosed in the US are triple negative, according to the American Cancer Society. Recently,  Roche, the giant Swiss drugmaker,  stated that their trial called IMpassion130 has shown that its immunotherapy Tecentriq in combination with the chemotherapy Abraxane is significantly reducing the risk of disease worsening or death in people with metastatic triple negative breast cancer.

Roche has confirmed that they have also recorded an encouraging overall survival benefit for the PD-L1 positive population, whose tumors express a protein that helps them evade immune system detection, at the interim analysis.

Roche Chief Medical Officer Sandra Horning stated, “Highly encouraged by these results, we plan to submit to health authorities globally with the aim of bringing this combination to people with triple negative breast cancer as soon as possible.”

 

 

 

 

 

Another company working on innovations for the treatment of breast cancer is Seattle based Atossa Genetics (NasdaqCM: ATOS). Recently, Atossa announced that it has opened its Phase 2 study of proprietary topical Endoxifen on mammographic breast density, or MBD, reduction. Studies by others have shown that a reduction in MBD reduces the risk of developing breast cancer and may potentially improve the accuracy of mammography in finding cancer.

The Phase 2 study is being conducted at Stockholm South General Hospital in Sweden and is being led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.

“Opening our first Phase 2 study using our proprietary topical Endoxifen marks a major milestone in our clinical development,” commented Steve Quay, Ph.D., MD, President and CEO of Atossa. “We look forward to working with Dr. Hall and his clinic to enroll women in this ground-breaking study and to move our topical Endoxifen a step closer to treating women with MBD. We are also making progress with our proprietary oral Endoxifen and have been evaluating a potential new indication in the pre-surgery, or “window of opportunity,” setting which involves treating newly diagnosed breast cancer patients prior to surgery. We believe this indication could have a quicker clinical and regulatory pathway. We plan to start a Phase 2 study in the next quarter in this window of opportunity setting and/or a Phase 2 study in breast cancer survivors who are “refractory” to tamoxifen,” added Dr. Quay.

The primary endpoint is to determine if topical Endoxifen administration results in an individual change in MBD, which will be measured after three and six months of entering the study. The secondary endpoints are safety and tolerability. Ninety participants will be randomized to one of three groups (one placebo group and two groups of different strengths of topical Endoxifen) with 30 participants per group. The objective of the study is to determine if MBD is reduced, and if so, the results will drive sample size calculations for a future Phase III study. Enrollment is anticipated to be completed by the end of 2018.

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

Roche ‘highly encouraged’ by Tecentriq results in breast cancer

Swiss drugmaker Roche said on Monday that a trial showed its immunotherapy Tecentriq plus the chemotherapy Abraxane significantly reduced the risk of disease worsening or death in people with metastatic triple negative breast cancer…

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Seattle Based Atossa Genetics Opens Their First Phase 2 Study Using Proprietary Topical Endoxifen For MDB

Seattle based Atossa Genetics Inc. (Nasdaq: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions has opened its Phase 2 study of proprietary topical Endoxifen on mammographic breast density, or MBD, reduction. The Phase 2 study is being conducted at Stockholm South General Hospital in Sweden and is being led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. The primary endpoint is to determine if topical Endoxifen administration results in an individual change in MBD, which will be measured after three and six months of entering the study. The secondary endpoints are safety and tolerability. Ninety participants will be randomized to one of three groups (one placebo group and two groups of different strengths of topical Endoxifen) with 30 participants per group. The objective of the study is to determine if MBD is reduced, and if so, the results will drive sample size calculations for a future Phase III study. Enrollment is anticipated to be completed by the end of 2018.

 

 

 

 

 

Steve Quay, Ph.D., MD, President and CEO of Atossa stated, “Opening our first Phase 2 study using our proprietary topical Endoxifen marks a major milestone in our clinical development. We look forward to working with Dr. Hall and his clinic to enroll women in this ground-breaking study and to move our topical Endoxifen a step closer to treating women with MBD. We are also making progress with our proprietary oral Endoxifen and have been evaluating a potential new indication in the pre-surgery, or “window of opportunity,” setting which involves treating newly diagnosed breast cancer patients prior to surgery. We believe this indication could have a quicker clinical and regulatory pathway. We plan to start a Phase 2 study in the next quarter in this window of opportunity setting and/or a Phase 2 study in breast cancer survivors who are “refractory” to tamoxifen.”

Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an FDA-approved drug to prevent new breast cancer as well as recurrent breast cancer in breast cancer patients. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. Atossa has completed a comprehensive Phase 1 clinical study using both a topical and an oral formulation of Endoxifen. Results from the topical arm of the Phase 1 study indicated that the topical formulation was safe, well tolerated and that topical Endoxifen crossed the skin barrier in a dose-dependent fashion.

Shares Of Atossa Moved Higher

Shares of Atossa (ATOS) moved higher today closing at $2.41/share up +2.99%.

Analyst Update

Maxim Group’s Biotechnology Analyst Jason McCarthy issued an update report recently and maintained his “Buy rating” and his $10/price target.

Learn More

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

Stay Informed! Stay Competitive!

Join us at Vista Partners!

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Atossa Genetics Opens Its Phase 2 Study of Topical Endoxifen to Treat Mammographic Breast Density

Atossa Genetics Inc. (ATOS) (“Atossa” or the “Company”), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced that it has opened its Phase 2 study of proprietary topical Endoxifen on mammographic..

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Atossa Reports Progress & Results Timeline For Male Breast Enlargement Trial

Seattle based Atossa Genetics Inc. (ATOS) (“Atossa”) is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions.  Atossa is developing topical Endoxifen for a condition in men called gynecomastia, which is male breast enlargement.

Mayo Clinic Research

According to the Mayo Clinic, 25% of men in the U.S. between the ages of 50-69, or approximately 10 million men, suffer from gynecomastia. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen.  For example, in prostate cancer treatment, testosterone is suppressed with androgen deprivation therapy resulting in higher estrogen levels that usually triggers gynecomastia. One recent study indicates that up to 90% of men taking androgen deprivation therapy suffer from gynecomastia and breast pain (Handoo Rhee, et al., October 18, 2014, BJU International). There is no FDA-approved pharmaceutical to treat gynecomastia. Current therapeutic approaches in these patients include the daily use of oral estrogen-suppressing medications and prophylactic breast bud irradiation which is often repeated.

 

 

 

 

 

Progress Announced!

Today, Atossa announced progress in its Phase 1 study of its proprietary topical Endoxifen in men as it has reported that it has completed dosing and clinical visits. The objectives of the placebo-controlled, repeat dose study of 24 healthy male volunteers are to assess the pharmacokinetics of a proprietary topical Endoxifen dosage form over 28 days, as well as to assess safety and tolerability.

Steve Quay, Ph.D., M.D., President and CEO of Atossa stated, “We are now proceeding to the final stages of this study, which are to complete analysis of blood samples and then collect and analyze the data. We expect to report preliminary results from the study in the next quarter.”

Atossa Reaches Further

In addition to gynecomastia, Atossa is also developing its proprietary topical Endoxifen to reduce Mammographic Breast Density (MBD), which has been shown in studies conducted by others to be an independent risk factor for developing breast cancer. To date, 34 U.S. states have enacted laws requiring that findings of MBD be communicated to the patient. And according to the National Cancer Institute, approximately 10 million women in the U.S. have high breast density (BI-RADS level C or D with “D” being the highest). Although oral tamoxifen has been shown to reduce MBD, the benefit-risk ratio is generally not acceptable to most patients. For example, it is estimated that only ~ 2% of women at high-risk of developing breast cancer, including those with MBD, take oral tamoxifen to prevent breast cancer because of the risks of, or actual side-effects of, oral tamoxifen. There is no FDA-approved treatment for MBD.

Atossa is planning a Phase 2 study of its topical Endoxifen in women with MBD. The study will be conducted at Stockholm South General Hospital in Sweden and will be led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.

The primary endpoint of this study is to determine if topical Endoxifen administration results in an individual change in MBD, which will be measured after three and six months. Secondary endpoints are safety and tolerability. The objective of the study is to determine the effect size on MBD between the placebo and active groups, which will permit sample size calculations in a future Phase III study. Enrollment is anticipated to be completed by the end of 2018.

Shares Surge

Shares of Atossa (ATOS) surged to as high as $3/share and traded ~2.62 million shares today and closed at $2.63/share up +5.2%.

Analyst Update

Maxim Group’s Biotechnology Analyst Jason McCarthy issued an update report and maintained his “Buy rating” and his $10/price target.

Learn More

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

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Atossa Genetics Completes all Dosing and Clinical Visits in its Phase 1 Study of Topical Endoxifen in Men

Atossa Genetics Inc. (ATOS) (“Atossa” or the “Company”), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced that it has completed dosing and clinical visits in its Phase 1 study of its proprietary..

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