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Apollo Endosurgery, Inc. to Participate at the 30th Annual ROTH Conference

On March 5, 2018 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq:APEN), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported that Company management is scheduled to present at the 30th Annual ROTH Conference being held March 11-14, 2018 at the Ritz-Carlton Laguna Niguel in Orange County, CA. The presentation is scheduled for Monday, March 12, 2018 at 11:00 am PT (Press release, , MAY 5, 2018, https://www.thestreet.com/newsletters [SID1234524626]).

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Cytokinetics to Present at March Investor Conferences

On March 5, 2018 Cytokinetics, Incorporated (Nasdaq:CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the following investor conferences (Press release, , MAY 5, 2018, View Source [SID1234524622]):

Cowen and Company 38th Annual Health Care Conference on Monday, March 12, 2018 at 2:50 PM EST at the Boston Marriott Copley Place Hotel in BostonInterested parties may access the live webcast of this presentation by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay of the presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

Drug Delivery: NanOlogy looks to transform chemotherapy with localized delivery platform

March 5, 2018
Paclitaxel revolutionized cancer treatment when it was first used as a chemotherapeutic in the 1990s. But although the product is a powerful cancer killer, patients taking systemic doses of paclitaxel have to endure side effects such as peripheral neuropathy and hair loss.

Marc Iacobucci and his team at NanOlogy believe they could replace the need for large, systemic doses of paclitaxel with the company’s unique formulation technique. NanOlogy has developed a way to turn drugs such as paclitaxel and docetaxel into sub-micron particles of pure drug that can be delivered locally to tumors.

"What we are aiming to do is show that we can increase efficacy but not contribute at all to systemic side effects. That’s the transformational part of this," Iacobucci told Drug Delivery Business News.

Using sonic energy and super-critical carbon dioxide, NanOlogy turns crystals of paclitaxel and docetaxel into sub-micron particles that are stable in powder form and can be suspended into simple fluids like saline.

"That allows us to inject those particles directly into a tumor or at the site of disease. Conventional means of making nanoparticles involve milling, which creates a lot of static charge. Because of the static charge, traditional nanoparticles aren’t stable and need to be coated with something," Iacobucci told us.

The company is developing and testing four products: a suspension of sub-micron paclitaxel, called NanoPac; a suspension of sub-micron docetaxel, called NanoDoce; and inhaled and topical formulations of NanoPac.

Ongoing clinical trials evaluating the NanoPac sterile suspension in patients with ovarian cancer, prostate cancer, pancreatic cancer and pancreatic mucinous cysts have shown promising results, he said.

In the company’s ovarian cancer trial, patients are given NanoPac after an ovarian tumor is removed. At the end of the surgical procedure, NanoPac is poured into the tumor cavity, according to Iacobucci. There, the particles locally release cancer-killing drugs for more than four weeks.

NanOlogy also plans to launch a clinical trial of its NanoDoce suspension later this year, testing the product in patients with bladder cancer. After a urologist has cut away the tumor, they plan to inject particles into the resection bed. NanOlogy expects that once the particles are delivered to the bladder, they will gradually release docetaxel to kill any residual tumor cells.

Across its trials, the company has seen positive efficacy results, Iacobucci said.

"As importantly, we’re not seeing any type of systemic side effects – at all," the managing director added.

The company’s topical paclitaxel product is being tested as a treatment for cutaneous metastases – a condition that arises in patients with advanced cancers. When advanced breast or lung cancer metastasizes to the skin, it can form chronic lesions on the patient’s body.

"These are stage-four patients. There is a lot of distress with that disease. They have a finite period of time to live and then they’re also dealing with the indignity and added discomfort and disfigurement of these chronic lesions," Iacobucci said.

Finally, NanOlogy is also working on an inhaled formulation of its paclitaxel product. In pre-clinical trials, the company has demonstrated that its product is retained in the lungs at meaningful levels for more than 14 days.

All of the company’s products are being tested in trials that were approved by the FDA as part of the 505(b)(2) pathway. In other words, NanOlogy can rely on established data for paclitaxel and docetaxel in the company’s regulatory applications.

But they also have a composition of matter patent that extends until 2036, which Iacobucci explained puts them in a unique position.

"We’ve got patent protection like a new molecular entity, but because these are known drugs, we’ve got the possibility of a streamlined path to approval," he said.

Iacobucci also noted that its product could pair nicely with the array of immunotherapies slated to hit the market in the U.S. There’s a synergistic relationship between taxanes, like paclitaxel and docetaxel, and immunotherapies.

"If you’re killing cells with chemotherapy, then you have cellular debris which is antigenic and you can increase the body’s immune response," Iacobucci explained.

NanOlogy is also actively looking for potential partners to help bring its cancer therapies to market.

"Part of what we are looking at is whether there is a large pharma partner in oncology that understands the transformational aspect of what we have and how it could be complementary to things that they’ve established. We could try to sell or license the technology to a company that has the infrastructure to get these products into the hands of patients," Iacobucci said.

GlycoMimetics Announces Design of Phase 3 Clinical Trial for GMI-1271 in Relapsed/Refractory AML

On March 5, 2018 GlycoMimetics, Inc. (NASDAQ: GLY) reported its design for a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate GMI-1271 in combination with MEC (Mitoxantrone, etoposide and Ara-C) or in combination with FAI (fludarabine, cytosine arabinoside and idarubicin) in individuals with relapsed/refractory acute myeloid leukemia (AML) (Press release, GlycoMimetics, MAR 5, 2018, View Source [SID1234524393]). The design is aligned with guidance received from the U.S. Food and Drug Administration (FDA). The single pivotal trial is planned to enroll 380 adult patients worldwide and is expected to begin in the third quarter of 2018. The primary endpoint will be overall survival, and censoring for transplant in the primary efficacy analysis will not be required. Key secondary endpoints will include incidence of severe mucositis and remission rate, which will be assessed in a hierarchical fashion for potential inclusion in the product labeling, if GMI-1271 is approved by the FDA. In 2017, GMI-1271 received Breakthrough Therapy Designation.

"Reaching alignment with the FDA on overall survival as the primary endpoint for the trial, without statistical censoring for transplant, positions GMI-1271 well for a potential successful outcome," said Rachel King, Chief Executive Officer of GlycoMimetics. "Getting more patients to transplant following treatment with GMI-1271 is one of our goals for this therapy. If we accomplish this, we hope GMI-1271 will contribute to prolonged overall survival for relapsed/refractory AML patients. We believe this is a rigorously designed Phase 3 trial that has the potential to bring us one step closer to meeting the significant unmet needs of this patient population. In addition, we believe that our trial design should streamline the path to data on overall survival, considered the ‘gold standard’ of clinical benefit, and that if this primary endpoint is achieved, it should position GMI-1271 optimally with U.S. and European regulatory agencies, as well as in the marketplace."

"Our development strategy now sets us up for multiple, value-creating clinical data readouts, the first of which is topline data from the ongoing Phase 3 trial of rivipansel in sickle cell disease in the second half of 2018," Ms. King added. "In early 2019, we anticipate topline data from our proof-of-concept trial of GMI-1271 in multiple myeloma, and now, by the end of 2020, we expect to have topline data from our pivotal trial of GMI-1271 in patients with relapsed/refractory AML."

Additional details regarding the Phase 3 trial will be provided in the company’s fourth quarter and fiscal year 2017 financial results teleconference on Tuesday, March 6, 2018, at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 1453008. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, participant code 1453008

G1 Therapeutics Announces Positive Trilaciclib Phase 2a Topline Data Showing Robust Myelopreservation Benefits in Patients with Small Cell Lung Cancer

On March 5, 2018 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported positive topline data from its Phase 2a trial evaluating trilaciclib in patients undergoing chemotherapy for first-line small cell lung cancer (SCLC) (Press release, G1 Therapeutics, MAR 5, 2018, View Source [SID1234524392]). Trilaciclib is a potential first-in-class short-acting CDK4/6 inhibitor in development to preserve hematopoietic stem cells and enhance immune system function (myelopreservation) during chemotherapy.

"The data from this trial showed clear evidence that trilaciclib preserved bone marrow and immune system function from the damaging effects of chemotherapy," said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. "Moreover, the myelopreservation effects demonstrated by trilaciclib improved patient outcomes. Chemotherapy continues to be a cornerstone of cancer treatment, and trilaciclib has the potential to benefit many of these patients."

Trial Design

This double-blind, placebo-controlled trial enrolled participants with a confirmed diagnosis of extensive-stage SCLC. The trial randomized 77 treatment-naïve participants in a 1:1 ratio, and 75 received trilaciclib or placebo administered intravenously prior to each dose of standard-of-care etoposide and carboplatin (EP) chemotherapy. Participants in both arms of the trial were able to receive standard supportive care as recommended by the trial investigator. Growth factors, including granulocyte colony-stimulating factor (G-CSF) and erythropoietin, and transfusion support were available to all participants. The statistical analysis plan prospectively defined several clinically-relevant hematologic endpoints.

Key Trial Findings

Data from this signal-generating Phase 2a trial demonstrated that trilaciclib reduced clinically relevant consequences of chemotherapy-induced myelosuppression versus placebo. Trilaciclib was well tolerated, with no Grade 3/4 trilaciclib-related treatment emergent adverse events (TEAEs) reported. Baseline demographics and disease characteristics were generally well balanced between the two arms. Key hematological results are shown in the table below.

Parameter

EP (1) + placebo
Patients
N = 37 EP + trilaciclib
Patients
N = 38 %
Reduction P-
value (2)
Patients with Gr 3/4 Hematologic TEAEs

27 (73.0%) 9 (23.7%) 67.5 % <0.0001
Patients with Gr 3/4 Neutropenia

30 (81.1%) 15 (39.5%) 51.3 % 0.0002
Patients with Gr 4 Neutropenia

16 (43.2%) 2 (5.3%) 87.7 % 0.0001
Patients with Gr 4 Neutropenia in Cycle 1

13 (35.1%) 1 (2.6%) 92.6 % 0.0003
Cycles with Febrile Neutropenia

5 1 80.8 % 0.1542
Patients with Febrile Neutropenia

3 (8.1%) 1 (2.6%) 67.9 % 0.2773
Patients with G-CSF Administration

24 (64.9%) 4 (10.5%) 83.8 % <0.0001
Patients with Chemotherapy Cycle Delays

25 (67.6%) 15 (39.5%) 41.6 % 0.0170
Patients with Chemotherapy Dose Reductions

13 (35.1%) 3 (7.9%) 77.5 % 0.0033

(1) etoposide and carboplatin
(2) significance testing at two-sided alpha = 0.2 per prospectively defined analysis plan
The trilaciclib arm also showed favorable trends with reduced Grade 3 anemia, red blood cell transfusions, and Grade 3 thrombocytopenia versus placebo. There was no Grade 4 anemia or thrombocytopenia in either arm.

In addition to demonstrating myelopreservation benefits across multiple hematopoietic lineages, trilaciclib showed favorable trends versus placebo for overall response rate (ORR), duration of response (DOR) and progression free survival (PFS). The survival data are still immature.

• ORR by blinded independent central review (BICR): trilaciclib 66.7%, placebo 62.2% (p=0.6759)

• Median DOR (BICR): trilaciclib 5.7 months, placebo 4.3 months (p=0.1449)

• PFS (investigator, including clinical progression) median: trilaciclib 6.2 months, placebo 5.0 months (hazard ratio 0.6, p=0.06)
The company plans to share these data with U.S. and European regulatory authorities this year and discuss next steps for the development of trilaciclib. The company also plans to present results from this trial, including updated data from the Phase 1b portion, at a medical meeting later this year.

G1 is currently conducting two additional clinical trials of trilaciclib to assess myelopreservation in second- / third-line SCLC and first- / second- / third-line triple-negative breast cancer, with preliminary data from both trials expected in the fourth quarter of 2018. In addition to myelopreservation, trilaciclib’s effect on overall survival (OS) is being evaluated in a Phase 2a trial in first-line extensive stage SCLC as part of a combination regimen with Tecentriq / carboplatin / etoposide. Enrollment of that trial was completed last month, two quarters ahead of schedule.

"The strength of this dataset provides us with a solid foundation to advance the development of trilaciclib and its ultimate commercialization," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "As shown by our non-exclusive collaboration with Genentech, there is significant interest in combining trilaciclib with checkpoint inhibitor / chemotherapy regimens. We believe that trilaciclib has the potential to become backbone therapy for multiple chemotherapeutic regimens across a variety of cancer types, delivering significant benefits to patients and creating a substantial long-term commercial opportunity."

Webcast and Conference Call

The G1 management team will host a conference call and webcast at 8 a.m. EST today. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 3098523. A live and archived webcast will be available in the Investors section of G1’s website at www.g1therapeutics.com.

About Trilaciclib (G1T28)

Trilaciclib is a potential first-in-class short-acting CDK4/6 inhibitor in development to preserve hematopoietic stem cells and enhance immune system function during chemotherapy. Trilaciclib is administered intravenously prior to chemotherapy and has the potential to significantly improve treatment outcomes.

Trilaciclib is being evaluated in four randomized Phase 2 clinical trials: a trial in newly diagnosed, treatment-naive SCLC patients (NCT02499770), a trial in previously treated SCLC patients (NCT02514447), a trial in patients with triple-negative breast cancer (NCT02978716), and a trial in combination with Tecentriq and chemotherapy in SCLC patients (NCT03041311).