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Nymox Reports on Symposium, Panel Discussion and Podium Presentation on Fexapotide at American Urological Association New York Section Annual Meeting in Havana

On November 7, 2017 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported two data presentations which were held on Fexapotide Triflutate studies at the Annual Meeting of the American Urological Association, New York Section in Havana, November 6 (Press release, Nymox, NOV 7, 2017, View Source;fvtc=4&fvtv=6907 [SID1234521687]). The abstract from the presentation is available at [email protected].

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The Podium presentation was given by Dr. Ivan Grunberger MD FACS, Professor of Clinical Urology, Weill Cornell Medical College and Chief of Urology, NYP Brooklyn Methodist Hospital. The paper was entitled "Prospective Randomized Double Blind Phase 3 Long-Term Results of U.S. Studies of Fexapotide Triflutate For BPH." Co-authors of the Podium presentation were Ronald Tutrone MD FACS of Baltimore MD, Mitchell Efros MD FACS of Garden City NY, Mohammed Bidair MD of San Diego CA, James Bailen MD FACS of Louisville KY, Franklin Gaylis MD FACS of San Diego CA, Barton Wachs MD of Long Beach CA, Richard Levin MD FACS of Baltimore MD, Susan Kalota MD of Tucson AZ, Sheldon Freedman MD FACS of Las Vegas NV, Barry Shepard MD FACS of Garden City NY, Jed Kaminetsky MD FACS of New York NY, Steven Gange MD FACS of Salt Lake City UT and Dr. Grunberger of Brooklyn NY.

Dr. Grunberger said, "Our presentation of the long-term data was very well received by the participants at the NY Section AUA meeting today. I received a lot of positive feedback following the presentation, and a great deal of interest in the use of Fexapotide Triflutate for patients with BPH once available."

The symposium "Fexapotide Triflutate: First in Class Injectable for BPH" was chaired by Dr. Tutrone. The other panel members at the Symposium were Dr. Jeffrey Snyder MD FACS of Denver CO, Dr. Kenneth Goldberg MD FACS of Carrollton TX, and Dr. Grunberger of Brooklyn NY.

Dr. Tutrone said, "I see Fexapotide Triflutate as a first line therapy for men suffering from BPH. It is a quick, painless and safe in-office procedure that takes minutes to do, and does not require a catheter. Its long term efficacy is better than oral medications, and there are no sexual side effects."

At the Symposium detailed clinical data on the Phase 3 clinical trials that have been completed for Fexapotide and that have shown excellent safety and efficacy for the treatment of BPH was presented. The main presentation was followed by a panel discussion and by an interactive question and answer session with the specialist doctors in attendance.

Dr. Snyder said, "I am most encouraged by the clinical trial data presented at the NY Section of the AUA meeting in Havana, Cuba today. This compound is a novel and effective approach to caring for men with symptoms of an enlarged prostate. It is my opinion that the drug will enhance the therapeutic armamentarium of urologists worldwide and maintain our expertise in the treatment of prostate disease. "

Fexapotide has been filed for approval in Europe and the filing was accepted for review in September 2017‎. Nymox’s lead drug Fexapotide has been in development for over 10 years and has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, and has been found after 7 years of prospective placebo controlled double blind studies of treatment of 995 U.S. men with prostate enlargement to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. The same clinical program has also shown in a long-term blinded placebo crossover group study an 82-95% reduction in the number of these patients who required surgery after they received crossover Fexapotide in the trial, as compared to patients who did not receive Fexapotide but instead received crossover conventional approved BPH treatments (p<.0001).

ImmunoGen Announces Webcasts of Presentations at Upcoming Conferences

On November 7, 2017 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the following presentations by Company management at upcoming investor conferences will be webcast (Press release, ImmunoGen, NOV 7, 2017, View Source [SID1234521679]):

Jefferies 2017 London Healthcare Conference
November 15, 2017 at 10:40am GMT
Evercore ISI Biopharma Catalyst/Deep Dive Conference
November 30, 2017 at 3:30pm ET
A webcast of each presentation will be accessible through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location for approximately two weeks.

DelMar Pharmaceuticals Appoints Saiid Zarrabian as Interim Chief Executive Officer

On November 7, 2017 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported the appointment of Mr. Saiid Zarrabian as interim Chief Executive Officer (Press release, DelMar Pharmaceuticals, NOV 7, 2017, View Source [SID1234521675]).

"DelMar is pleased to welcome Mr. Zarrabian as interim CEO at an important time for our company," said Dr. Erich Mohr, DelMar’s Chairman of the Board. "Saiid’s experience in overseeing the growth of multiple companies will augment DelMar’s management as we continue to transition to a late-stage development company and seek additional opportunities to maximize shareholder value."

Jeffrey Bacha, cofounder of DelMar, will continue in his senior management role as President and in the newly created position of Chief Operating Officer (COO). Both Mr. Zarrabian and Mr. Bacha will continue to serve on the Company’s Board of Directors.

"I am delighted to accept the position of interim CEO and to work with Jeffrey and the DelMar team as well as with Erich and the Board with the goal of creating value for our shareholders, said Mr. Zarrabian. "DelMar has successfully advanced VAL-083 into a pivotal clinical trial and has established several additional opportunities that we believe can create significant value in the treatment of multiple cancer indications. I look forward to leading the company at this critical time and to contributing to the success of DelMar."

Saiid Zarrabian joined the DelMar Board of Directors in July, 2017. Mr. Zarrabian is a highly successful industry veteran. He is currently serving as an advisor to Redline Capital Partners, S.A., a Luxemburg-based investment firm. Mr. Zarrabian has previously served as Chairman and member of the board of directors of La Jolla Pharmaceutical Company during the company’s transition from an OTC listed company to a NASDAQ listed company. He also served as President of the Protein Production Division of Intrexon Corporation, a synthetic biology company. Prior to that, he served as Chief Executive Officer and a member of the board of directors of Cyntellect, Inc., a stem cell processing and visualization Instrumentation company until it’s sale in 2012. He has previously served as President and Chief Operating Officer of Senomyx, Inc., a company focused on discovery and commercialization of new flavor ingredients, and as Chief Operating Officer of Pharmacopeia, Inc., a former publicly-traded provider of combinatorial chemistry discovery services and compounds, where he also served as President and Chief Operating Officer of its MSI Division. In addition, Mr. Zarrabian has served on numerous private and public company boards, including at Immune Therapeutics, Inc.; Exemplar Pharma, LLC; Ambit Biosciences Corporation; eMolecules, Inc.; and Penwest Pharmaceuticals CO.

Cellectar Announces Updated Median Overall Survival of 26.2 Months from Cohort 1 of CLR 131 Phase 1 Trial in Advanced Multiple Myeloma

On November 7, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB), an oncology-focused, clinical stage biotechnology company (the "company"), reported that the ongoing median overall survival (mOS) from Cohort 1 of the Phase 1 study of its lead PDC compound, CLR 131 has reached 26.2 months in patients with multiple myeloma (Press release, Cellectar Biosciences, NOV 7, 2017, View Source [SID1234521672]). While no head-to-head studies have been conducted to date with CLR 131, for comparison, the median overall survival benefit seen with the three most recently FDA-approved third line therapies for multiple myeloma ranges from 11.9 – 18.6 months in separate trials.

In the first cohort, the 26.2-month mOS benefit was observed following a single 30-minute infusion of 12.5mCi/m2 in heavily pretreated patients who had an average of 5.8 prior lines of therapy. The second cohort, which received a single dose of 18.75 mCi/m2 has experienced a mOS of 15.4 months to date, and the third cohort, which received a single dose of 25 mCi/m2 has experienced 10 months of mOS to date. It is important to note that the trial remains ongoing, and the median overall survivals for all cohorts could continue to increase over time.

As previously disclosed, Cohorts 2 and 3 were initiated approximately 10 and 18 months after the initiation of Cohort 1, thus accounting for the difference in mOS between the cohorts. Even though the mOS in each cohort remains ongoing, the values in all cohorts already compare favorably with the historic survival benefit seen with standard chemotherapy in a relapsed/refractory multiple myeloma setting. The company continues to collect overall survival data on all evaluable trial participants and expects to provide timely updates as the data mature.

"The ongoing median overall survival from the first cohort exceeding two years, and the second cohort’s mOS surpassing 15 months underscore the clinical potential of our CLR 131 program in multiple myeloma," said Jim Caruso, president and CEO of Cellectar Biosciences. "These observations taken together with the recently reported partial response from Cohort 3 leave us very optimistic with regard to advancing this compound through the clinic."

Bio-Path Holdings Highlights Advancements in Preclinical Discovery Efforts

On November 7, 2017 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 the selection of its third drug candidate, BP1003, for the treatment of pancreatic cancer and provided an update on several of its preclinical discovery efforts (Press release, Bio-Path Holdings, NOV 7, 2017, View Source [SID1234521671]).

"We are excited about the ways in which we continue to leverage our novel DNAbilize technology and are particularly pleased to be moving forward toward the treatment of solid tumors," said Peter H. Nielsen, chief executive officer of Bio-Path Holdings. "As we advance our current drug candidates into additional indications and add new targets, we continue to establish the DNAbilize platform as a premier RNAi nanoparticle technology for systemic treatment of disease."

Bio-Path’s third drug candidate, BP1003, targets the Stat3 protein and is currently in preclinical development in a pancreatic patient-derived tumor model. Previous preclinical models have shown BP1003 to successfully penetrate pancreatic tumors and to significantly enhance the efficacy of standard frontline treatments. Bio-Path intends to initiate IND enabling studies of BP1003 in 2018.

BP1002, Bio-Path’s second drug candidate, targets the Bcl2 protein and has demonstrated strong anti-non-Hodgkin’s lymphoma activity in cell lines and in an animal model. The company has completed IND enabling studies and expects to initiate a Phase 1 trial in lymphoma in 2018.

Prexigebersen, Bio-Path’s lead drug compound, targets the Grb2 protein and is currently in Phase 2 development for the treatment of blood cancers. In recently completed preclinical models, prexigebersen effectively penetrated ovarian tumors and has demonstrated clinical benefit both as a monotherapy and in combination with standard frontline therapies. Bio-Path plans to initiate a Phase 1 clinical trial of prexigebersen targeting several solid tumors types in 2018.