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Additional Clinical Studies Supporting the Benefits of OMIDRIA® Presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting

On April 19, 2018 Omeros Corporation (NASDAQ: OMER) reported that the results of four real-world clinical studies evaluating the benefits of OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% were presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting held in Washington, D.C., April 13-17, 2018 (Press release, Omeros, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343403 [SID1234525548]). The studies examined the use of OMIDRIA in both routine and complex cataract surgery cases performed in high-volume surgery centers, with and without femtosecond laser.

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The first presentation, a retrospective analysis, assessed whether the use of OMIDRIA in femtosecond laser-assisted cataract surgery (FLACS) – a procedure that is known to cause miosis (pupil constriction) due to the increased inflammation generated by the laser – leads to a reduction in the need for pupil expansion devices and in surgical time. Investigators compared 100 consecutive femtosecond-assisted cataract procedures in which epinephrine was used in the irrigation solution to 100 consecutive femtosecond-assisted procedures performed with OMIDRIA. In the epinephrine group, 12 eyes (12 percent) required a Malyugin Ring to maintain or improve pupil size versus 2 eyes (2 percent) in the OMIDRIA group (p=0.009). Surgical times in the OMIDRIA group were reduced by an average of 78 seconds compared to those in the epinephrine group (p = 0.007). The authors conclude that use of OMIDRIA achieves faster surgery and a more manageable pupil.1

The second clinical study assessed the effects of OMIDRIA on pupil dilation when used early in patients undergoing both FLACS and traditional cataract surgery. A total of 77 patients underwent either traditional phacoemulsification (n=57) or FLACS (n=20), all of whom received OMIDRIA in the irrigation solution and administered through the side-port incision at the beginning of the case. Pupil diameter was measured before and after OMIDRIA administration as well as prior to intraocular lens (IOL) insertion. In the traditional phacoemulsification cases, the mean pupil diameter was 6.65 mm at baseline and 7.42 mm intraoperatively before IOL insertion. Similarly, in the FLACS group, the mean pupil diameter was 6.69 mm at baseline and 7.65 mm prior to IOL insertion. The study demonstrates that OMIDRIA is effective in maintaining and even increasing pupil size in traditional as well as in femtosecond laser-assisted cataract procedures, which, without OMIDRIA, frequently induce miosis.2

A third study evaluated the effect of OMIDRIA on pupil dilation, iris billowing and iris prolapse in patients at high risk for intraoperative floppy iris syndrome (IFIS). The randomized, double-masked, investigator-initiated study enrolled 50 male subjects (50 eyes) who had been exposed to tamsulosin (Flomax), a prostate drug that causes IFIS, prior to cataract surgery. The 50 patients were randomized 1:1 to receive either OMIDRIA or control. All subjects underwent routine cataract surgery recorded endoscopically from the perspective of the ophthalmic microscope. Investigators assessed pupil diameter and IFIS symptoms in all 50 subjects (50 eyes). Mean pupil diameter during surgery for the control group was 5.92mm and was 7.08mm for the OMIDRIA-treated group (p < 0.001). Symptoms of IFIS were observed in all 25 (100 percent) patients in the control group and in only 3 (12 percent) of patients who received OMIDRIA. Iris prolapse occurred in 14 (56 percent) subjects in the control group versus 3 (12 percent) in the OMIDRIA group. Iris billowing, graded according to a new grading scale for intraoperative iris abnormalities, averaged 2.36 in the control group and 1.68 in the treatment group, with Stage 3 (severe) billowing seen in 10 (40 percent) vehicle subjects and 1 (4 percent) treatment subject. All of the comparisons related to IFIS symptoms were statistically significant with p < 0.001. The authors conclude that OMIDRIA offers significant benefits in IFIS cases and could reduce the complexity and unpredictability of such cases.3

A fourth study assessed clinical outcomes and surgical practice patterns for cataract patients treated with either OMIDRIA or epinephrine. This retrospective chart review included patients who received treatment at one of two clinics by a single surgeon practicing at both locations. A total of 635 eyes in 375 patients underwent cataract surgery with either OMIDRIA (n=275) or epinephrine (n=360) in the irrigation solution. Mean surgical time was significantly shorter with OMIDRIA versus epinephrine (16.5 min vs 17.8 min; p = 0.006), and only 6 (2.2 percent) pupil expansion devices were required in the OMIDRIA group vs 24 (6.7 percent) in the epinephrine group (p = 0.008). Investigators conclude that OMIDRIA reduced surgical time and decreased the need for pupil expansion devices compared to the use of intracameral epinephrine.4

Detailed descriptions of all four clinical studies have been accepted for publication by, or are planned for submission to, peer-reviewed journals.

About OMIDRIA

Omeros’ OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is the first and only FDA-approved product of its kind and is marketed in the U.S. for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. OMIDRIA also is the only NSAID-containing product FDA-approved for intraocular use. In post-launch studies across conventional and femtosecond laser-assisted cataract surgery, OMIDRIA has been shown (1) to be effective in patients with intraoperative floppy iris syndrome (IFIS), pseudoexfoliation and other ophthalmic conditions, (2) to significantly reduce complication rates, use of pupil-expanding devices, and surgical times, and (3) to significantly improve uncorrected visual acuity on the first day following cataract surgery. While OMIDRIA is broadly indicated for use in cataract surgery, the above outcomes are not in its currently approved labeling. Surgical time was not an endpoint in the OMIDRIA Phase 3 clinical trials and did not reach statistical significance in post hoc analysis of the Phase 3 data.

Important Safety Information for OMIDRIA

Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two percent or greater are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and OMIDRIA-treated patients. OMIDRIA must be added to irrigation solution prior to intraocular use.

Collectively improving the standard of breast cancer treatment at ASBrS 2018

In the organization’s own words, "The American Society of Breast Surgeons, the primary leadership organization for general surgeons who treat patients with breast disease, is committed to continually improving the practice of breast surgery by serving as an advocate for surgeons who seek excellence in the care of breast patients (Press release, Dune Medical Devices, APR 19, 2018, View Source [SID1234525547]). This mission is accomplished by providing a forum for the exchange of ideas and by promoting education, research, and the development of advanced surgical techniques. Founded in 1995, the Society has grown to more than 3000 members in the United States and 35 countries throughout the world."

The Society’s Annual Meeting, May 2-6, 2018 in Orlando, is the breast cancer community’s greatest opportunity to connect, collaborate and collectively advance the standard of care for tens of thousands of breast cancer patients.

We want physicians interested in reducing positive margins and improving the patient experience to visit us at booth #101 to discuss MarginProbe’s ability to detect microscopic cancer intraoperatively and review the latest clinical data supporting its use. We want attendees to appreciate the value of MarginProbe in significantly reducing the risk of positive margins thereby preventing additional surgeries. As a result, patients avoid disruption to their adjuvant care plan, reduce the risks and costs associated with additional surgeries and return to their lives prior to their cancer diagnosis.

MarginProbe will also be discussed in the Wednesday May 2nd 7am – 4pm: Beginner and Intermediate Oncoplastic Breast Surgery Skills Courses with Cadaver Lab with Drs. Dennis Holmes and Julie Reiland.

You can find the MarginProbe team throughout ASBrS 2018 at booth #101.

BenevolentAI Grabs $115 Million to Advance its Drug Development Programs

The use of artificial intelligence and machine learning in drug development has been ramping up and investors are taking keen notice of the growing trend (Press release, BioSpace, APR 19, 2018, View Source [SID1234525546]). This morning London-based BenevolentAI snagged $115 million to give it a total of about $200 million in its coffers.

BenevolentAI, which is applying artificial intelligence to develop new medicines for hard to treat diseases, said it will use the funds from the financing round to advance its artificial intelligence driven drug development programs. The company also said it will use the financing to broaden the disease areas on which it focuses, and extend its AI platform capabilities even further. Some of the proceeds from the financing round will be used to explore other science-based industries, including agriculture and energy storage, the company said.

Following the latest financing, BenevolentAI said it has a pre-money valuation of $2 billion.

BenevolentAI has 20 drug programs in its pipeline. Currently, BenevolentAI is using its platform to develop treatments for a wide range of unmet patient needs in various areas including Motor Neuron Disease, Parkinson’s disease, Glioblastoma and Sarcopenia.

The latest funding round, which was primarily supported by investors from the United States, is one of the largest in the AI pharmaceutical sector, the company said this morning. The $115 million the company gathered dwarfs the $15 million secured by the China-based AI startup XtalPi Inc. earlier this year.

Kevin Mulaney, founder and chairman of BenevolentAI, said the financial support the company received in its latest fundraising effort reflects the "rapidly growing global interest in the AI pharmaceutical sector" and the company’s position in that field.

"We have come a very long way since we founded the business in 2013. The capabilities of our technology didn’t exist six years ago. We are pioneering this sector and have evolved into a fully integrated, AI enabled drug development company with the ability to deliver better medicines at previously unimaginable speeds – this ultimately means patients will receive the right medicines, at a lower cost, in less time," Mulaney said in a statement.

The U.K. company said its drug-development portfolio shows that its AI platform can cut early-stage drug discovery by four years. Additionally, BenevolentAI said it can potentially deliver efficiencies in the entire drug development process of 60 percent against pharmaceutical industry averages – "significantly disrupting an industry that spends $180 billion a year on R&D."

The company boldly said its artificial intelligence program can "outperform human scientists" in understanding the cause of a disease and is also capable of "quickly generating drug candidates at scale."

"The technology is also able to decipher the molecular process of disease and link these disease signatures within patients to ensure that the best drug candidate is given to the best patient responders – the ‘right drugs in the right patients’," the company said on its website.

The use of artificial intelligence in drug development is becoming more and more common. In July 2017 pharma giant GlaxoSmithKline forged a $43 million deal with AI company Exscientia to spur drug development. GSK said it will be using AI to discover novel and selective small molecules for up to 10 disease-related targets across multiple therapeutic areas. Also in July 2017 the Mayo Clinic and nference launched a startup company called Qrativ that is focused on drug development that will be powered by clinical expertise and artificial intelligence. Innovator Elon Musk launched the biotech company Neuralink that has the lofty goal of linking the human brain with a computer.

AstraZeneca’s Tagrisso Nabs Another Lung Cancer Approval

On April 19, 2018 The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) in tumors with epidermal growth factor receptor (EGFR) mutations (Press release, BioSpace, APR 19, 2018, View Source [SID1234525545]).

The mutations, exon 19 deletions or exon 21 L858R mutations, will be detected by an FDA-approved test. The decision was based on data form the Phase III FLAURA clinical trial. Results were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress and published in the New England Journal of Medicine.

The FLAURA trial compared Tagrisso to current first-line EGFR tyrosine kinase inhibitors, erlotinib or gefitinib, in patients who had not received previous treatment for locally-advanced or metastatic EGFR-mutation NSCLC. It met the primary endpoint of progression-free survival, and were consistent across all pre-specified patient subgroups.

Patients receiving Tagrisso had about 18.9 months on average before the disease got worse compared to 10.2 months for patients receiving traditional treatments.

Tagrisso is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against central nervous system cancers. It has been approved in the U.S. and Brazil for first-line EGFRm advanced NSCLC, and in more than 75 countries, including the U.S., Europe, Japan and China, for patients with EGFR T790M mutation-positive advanced NSCLC. It is also being evaluated as an adjuvant and in combination with other treatments.

It has also been approved in the U.S. for second-line treatment of patients with metastatic EGFRm NSCLC, whose disease has on or after a first-line EGFR-TKI round of therapy and who have developed the secondary T790 mutation. The drug received both Breakthrough Therapy and Priority Review designations from the FDA in 2017 for the first-line setting.

"Today’s FDA approval of Tagrisso in the first-line setting is an exciting milestone for patients and our company," said Dave Fredrickson, executive vice president, Head of the Oncology Business Unit at AstraZeneca, in a statement. "Tagrisso delivered unprecedented median progression-free survival data across all pre-specified patient subgroups, including patients with or without CNS metastases, and could prolong the lives of more patients without their tumors growing or spreading."

The drug is being evaluated in Europe and Japan as a first-line treatment, with regulatory decisions expected in the second half of this year. AstraZeneca has projected that Tagrisso could, at its peak, bring in $4 billion per year.

Lung cancer accounts for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined. It is the leading cause of cancer death for both men and women. About 10 to 15 percent of patients in the U.S. and Europe and about 30 to 40 percent in Asia, have EGFRm NSCLC. They are especially sensitive to EGFR-TKI treatments, but those cancers typically develop resistance to that treatment, leading to disease progression.

"The approval of osimertinib in the first-line setting represents a major advance in the treatment of patients with EGFR mutations and a significant change in the treatment paradigm," stated Suresh Ramalingam, principal investigator of the FLRUA trial, a researcher with the Winship Cancer Institute of Emory University in Atlanta. "Osimertinib provides robust improvements in progression-free survival with no unexpected safety signals compared to the previous generation of EGFR inhibitors."

Pre-Clinical Data Demonstrating Promising Potential of Prexigebersen as Treatment for Solid Tumors in
Gynecologic Malignancies Presented at American Association for Cancer Research Annual Meeting

On April 19, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that data from pre-clinical studies supporting the potential of prexigebersen (BP1001, liposomal Grb2 antisense), in the treatment of solid tumors in gynecologic malignancies were presented in a poster at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), which took place in Chicago, IL (Press release, Bio-Path Holdings, APR 19, 2018, View Source [SID1234525544]).

The poster titled, "Grabbing GRB2: The use of Liposome-incorporated Grb2 antisense oligonucleotides as a novel therapy in gynecologic malignancies," was presented by Olivia D. Lara, M.D., University of Texas MD Anderson Cancer Center, Department of Gynecologic Oncology during the Experimental and Molecular Therapeutics Poster Session. The data summarize results from studies investigating the expression of GRB2 in a series of in vitro experiments in high-grade serous (HGSC) and uterine (UC) carcinoma models. The study also examined the biological effects of prexigebersen in HGSC mice models (OVCAR 5), first in a dose-defining experiment then in combination with standard dose paclitaxel.

The data showed there was an eighty-six percent (86%) decrease in tumor burden (p<0.05), and multinodular burden (p<0.01) in the combination prexigebersen/paclitaxel group compared to control. In addition, there was no apparent toxicity with mice on combination therapy losing less weight than the paclitaxel-only group (P = 0.005).

"We are delighted to present these very encouraging findings at this year’s AACR (Free AACR Whitepaper) before an audience of the world’s leading cancer researchers and clinicians," stated Peter H. Nielsen, chief executive officer of Bio-Path Holdings. "Our research continues to suggest that prexigebersen-based combination therapy may offer an attractive method for targeting solid tumors and these findings establish the GRB2/GAB2 complex as an important target for prexigebersen. We look forward to advancing this promising therapy in gynecologic and other solid tumor cancers and plan to initiate first-in-human studies as early as the end of this year."