|Merrimack Announces Final Clinical Results for MM-302 Phase 1 Study; AMPIO Announces Ampion STRIDE Study Results|
|By Marilyn Mullen|
|Monday, 20 April 2015 22:08|
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 20, 2015.
Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) announced updated and final clinical results for the Phase 1 study of MM-302, a novel HER2-targeted liposomal doxorubicin, in HER2-positive metastatic breast cancer. The results were presented today by Patricia LoRusso, D.O., in a clinical trials plenary oral session at the 2015 American Association for Cancer Research (AACR) Annual Meeting in Philadelphia, PA. Data described the safety and promising clinical activity of MM-302 in patients with advanced HER2-positive metastatic breast cancer.
Results from the trial showed that the group of patients (n=62) treated with 30 mg/m2 or more of MM-302 alone, in combination with trastuzumab or with trastuzumab and cyclophosphamide, had a median progression free survival (mPFS) of 7.6 months (95% CI: 3.6-10.9 months) and an overall response rate (ORR) of 11%. Of note, 25 patients who had not been previously treated with anthracyclines had an mPFS of 11 months (95% CI: 1.8-13.1 months) and an ORR of 24%.
"HER2-positive breast cancer affects approximately 20% of all breast cancer patients and represents a particularly aggressive form of breast cancer. Despite recent advancements in treatment, the vast majority of metastatic breast cancer patients will progress and have a high need for additional therapies," said Patricia LoRusso, D.O., professor of medicine in the Division of Oncology at Yale University. "We are encouraged by these data on the safety and promising clinical activity of MM-302 in patients who have exhausted many therapeutic options for their disease. Our results support the further evaluation of MM-302 in an anthracycline-naive population in the HERMIONE trial."
The most frequent adverse events occurring in greater than 20% of the population in this Phase 1 study were constipation, cough, decreased appetite, diarrhea, dyspnea, fatigue, nausea, neutropenia, stomatitis and vomiting. The most common Grade 3/4 adverse event was neutropenia observed in 8 patients. Six out of 69 patients (9%) had protocol-defined asymptomatic declines in left ventricular ejection fraction (LVEF). In 1 of the 6 patients, this was reported as a Grade 1 cardiac failure that was possibly related to study treatment.
"As an antibody-drug conjugate, MM-302 is designed to maximize targeted delivery to the tumor while trying to reduce the cardiotoxic effects of traditional anthracycline chemotherapies," said Thomas Wickham, Ph.D., Vice President of Development and MM-302 Project Team Leader. "The study population in this Phase 1 trial is heavily pre-treated, as the majority of patients have already progressed on a median of four prior therapies. We are encouraged by the 7.6 month median progression-free survival in this patient population and are looking forward to our next steps for the MM-302 clinical development program."
Merrimack is currently enrolling the HERMIONE study that is designed to support a potential application for accelerated approval in the U.S. and conditional marketing authorization in the E.U. The HERMIONE study is for HER2-positive, metastatic breast cancer patients who are anthracycline-naive and have been previously treated with pertuzumab and T-DM1-containing regimens.
Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that the multiple injection STRIDE study AP008 did not reach its primary endpoint against the saline control even though there was a statistically significant reduction in pain compared to baseline for patients receiving Ampion™ (WOMAC A: p < 0.001). This pain reduction with Ampion™ was consistent across all sites and with our previously reported studies (SPRING and STRUT). Ampion™ is safe and well tolerated.
Ampio Pharmaceuticals launched the Phase III program for AmpionTM – a low molecular weight filtrate of an FDA approved biologic – to treat pain due to osteoarthritis (OA) of the knee. Each patient received three 4ml intra-articular injections of Ampion™or the saline placebo, one at baseline, the second at two weeks and the third at four weeks. In OA, saline is known to be a partial therapeutic and not a true placebo, but has been the control used in all published OA drug trials.
In the STRIDE study the saline control arm varied well out of a normal range, when compared to previous Ampion™ studies and from the published results for other OA drugs. In the STRIDE study, the percentage change in WOMAC A for the saline control arm ranged from 12 percent to 60 percent from site to site. This is more than twice the range we have previously seen in our studies. Historically, in larger studies, the response to saline has been reported to be in a range of 30-35 percent.
In addition, we are analyzing the demographic differences between the patient populations in the STRIDE study compared to the SPRING and STRUT studies.
Disease Severity: 68 percent of subjects in the STRIDE study had severe disease (Kellgren-Lawrence 4) versus 38 percent in the STRUT study and 23 percent in the SPRING study;
Weight: Patients in the STRIDE study were significantly heavier than patients in the STRUT study or other published trials.
Once we have had more time to analyze the STRIDE data, we will host a conference call to present our findings and answer questions from our shareholders.
We will meet with the FDA to discuss our full clinical findings as soon as practical. The FDA requires a certain minimum number of patients exposed for an acute therapy. The additional patient exposure from the STRIDE study allows us to meet this requirement. We believe that the SPRING and STRUT studies could be used as "two well conducted trials" necessary for the BLA filing.
"There is ample evidence from our multiple clinical trials that AmpionTM provides significant clinical benefit to a large number of patients with osteoarthritis of the knee," said Michael Macaluso, CEO, "We are confident that AmpionTM will significantly improve the quality of life of patients suffering from OA."
Based on current projections, Ampio Pharmaceuticals has sufficient funds to continue operations through 2016, complete additional trials if necessary, manufacture AmpionTM for the BLA filing and complete the activities necessary to bring our product to market approval. The company's previously issued financial guidance for 2015 remains unchanged.
ALR Technologies Inc. (OTCQB:ALRT), a leading remote chronic care management and medical device company, is pleased to announce that Clay-Platte Family Medicine Clinic, one of the largest primary care clinics in the Northland of Kansas City, has signed a contract with ALRT to improve diabetes health outcomes using the Health-e-Connect remote chronic care management system.
Argos Therapeutics Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced the company will present an update on the ongoing pivotal phase 3 ADAPT clinical trial of AGS-003 in combination with targeted therapy for the treatment of newly diagnosed metastatic renal cell carcinoma (mRCC) during the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting May 29th-June 2nd at McCormick Place in Chicago.
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced that the Company has engaged Huntsworth Health, a global healthcare marketing and communications agency to build a global KOL advocacy campaign for CBMG's ReJoinTM human adipose-derived mesenchymal progenitor cell (haMPC) clinical trials for the treatment of Knee Osteoarthritis.
Connecture, Inc. (Nasdaq:CNXR), a provider of web-based information systems used to create health insurance marketplaces, will release its 2015 first quarter financial results on Thursday, May 7, 2015 after market close and will host a conference call to follow at 5:00 p.m. Eastern Time.
Richard E. Perlman, Executive Chairman and James K. Price, Chief Executive Officer of ExamWorks Group, Inc. (NYSE:EXAM), will present at the Deutsche Bank Annual Health Care Conference, May 6th at 4:10 p.m. The conference will be held at the Intercontinental Hotel, Boston, Massachusetts.
Foamix Pharmaceuticals Ltd. (Nasdaq:FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing its proprietary topical foams to address unmet needs in dermatology, today announced the closing of its follow-on public offering.
Immunomedics, Inc., (Nasdaq:IMMU) today announced that, in a mid-stage clinical study, a multitude of patients with late stage solid cancers showed significant and durable tumor shrinkage after receiving treatments with sacituzumab govitecan, the Company's lead antibody-directed chemotherapeutic agent in development.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it will present at the following conferences in May: At 2:10PM ET on Wednesday, May 6, 2015, Glenn Coleman, Integra's Chief Financial Officer, will present at the Deutsche Bank 40th Annual Health Care Conference in Boston, Massachusetts. This presentation will be webcast; At 9:20AM PT on Thursday, May 14, 2015, Mr. Coleman will present at the Bank of America Merrill Lynch 2015 Health Care Conference in Las Vegas, Nevada. This presentation will be webcast; At 10:30AM ET on Monday, May 18, 2015, Mr. Coleman will present at the UBS 2015 Global Healthcare Conference in New York City. This presentation will be webcast.
KannaLife Sciences, a Medical Marijuana, Inc. (OTC PINK:MJNA) portfolio company, is on the front lines developing novel cannabinoid based therapeutics and health care related solutions for the public. MJNA is proud to announce that KannaLife was the subject of extensive interviews in the making of the third part of CNN's documentary series Weed 3: The Marijuana Revolution.
LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, announced today that it will report financial results for the first quarter ended March 31, 2015 after the market close on Wednesday, May 6, 2015.
LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that it will release its first quarter 2015 financial results on Tuesday, April 28, 2015, after the market close. The company has scheduled a conference call for 5:00 PM EDT the same day to discuss the results, business highlights, and company outlook.
Lumenis Ltd. (Nasdaq:LMNS), the world's largest energy-based medical company for surgical, ophthalmology, and aesthetic applications announced today that the company will feature its dual CO2 laser technology at an educational symposium: "Challenging Cases Helped by Dual CO2 Laser Modalities" at the Combined Otolaryngology Spring Meetings (COSM) 2015, being held in Boston, Mass., from April 22 – 26, 2015.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today long-term clinical trial results from the Company's NX-1207 Phase 2 prostate cancer study NX03-0040. The new results demonstrate statistically significant (p=.0067) better outcomes at up to 2.8 years for NX-1207 treated patients compared to controls.
Performant Financial Corporation (Nasdaq:PFMT) a leader in the identification and recovery of improper payments in the Healthcare, Government and Student Loan industries today announced it was awarded a recovery audit contract based on a competitive selection process by Cambia Health Solutions.
Perseon Corporation (Nasdaq:PRSN), a leading provider of medical systems that utilize heat therapy to treat cancer, today announced plans to release its financial results for the first quarter ended March 31, 2015 before the market opens on Thursday, May 14, 2015.
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that the world class team of scientists, physicians and academics that make up its international Diabetes Consortium is now complete with the addition of the final two members, Dr. Thomas Stratmann and Dr. Axel Kornerup Hansen.
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today presents preclinical data on RX-3117 at the 2015 American Association for Cancer Research (AACR) Annual Meeting in Philadelphia.
SAGE Therapeutics (Nasdaq:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-threatening, rare central nervous system (CNS) disorders, today announced completion of treatment for the first patient enrolled in its now initiated open-label expanded access protocol, designated Study 302.
Symmetry Surgical Inc. (Nasdaq:SSRG) announced today that it will release first quarter 2015 financial results for the period ending April 4, 2015 before the market opens on Thursday, May 7, 2015.
Wellness Center USA, Inc. (OTCQB:WCUI), today reports that it has completed its second and final payment to JMJ Financial (JMJ) under the Note Termination Agreement previously announced on March 19, 2015.