Atossa Genetics announced 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 and HER2 negative 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.” 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.
Friday, July 13, 2018
Array cancer combo gets updated recommendation from guideline body
Array BioPharma Inc. (NASDAQ: ARRY) today announced that the National Comprehensive Cancer Network (NCCN) has updated the Clinical Practice Guidelines in Oncology for Melanoma to include BRAFTOVI™ in combination with MEKTOVI® as a Category 1 first-line and second-line treatment option for patients with BRAFV600E or BRAFV600K-mutant metastatic or unresectable melanoma.
The U.S. Food and Drug Administration (FDA) approved BRAFTOVI in combination with MEKTOVI on June 27, 2018 for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test based on data from the pivotal Phase 3 COLUMBUS trial, which demonstrated the combination doubled median progression-free survival (mPFS) compared to vemurafenib alone (14.9 months versus 7.3 months, respectively [hazard ratio (HR) (0.54), (95% CI 0.41-0.71), p<0.0001]. In the trial, only 5% of patients who received BRAFTOVI + MEKTOVI discontinued treatment due to adverse reactions. BRAFTOVI is not indicated for the treatment of patients with wild-type BRAF melanoma.
“We greatly appreciate the NCCN’s rapid evaluation and recommendation for BRAFTOVI + MEKTOVI as a Category 1 treatment option for patients with advanced BRAF-mutant melanoma,” said Ron Squarer, Chief Executive Officer. “These products represent a new standard of care for patients with this deadly type of skin cancer.”
A Category 1 recommendation indicates that, based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Acceleron cut to neutral by Morgan Stanley
Acceleron downgraded to Equal Weight after data-driven rally at Morgan Stanley. As previously reported, Morgan Stanley analyst Matthew Harrison downgraded Acceleron to Equal Weight from Overweight, stating that he believes the risk/reward is now more balanced with both of its Phase 3 readouts being reflected in valuation with the stock’s recent move higher. He expects limited upside for the shares until management presents greater detail on the magnitude of the efficacy response and safety, which he thinks likely will come at the ASH meeting. Harrison keeps a $50 price target on Acceleron shares.
Biocept announces a provider agreement for Mideast, Asia, Africa
Biocept announces a provider agreement with Alliance Global FZ to market and distribute Biocept’s Target Selector liquid biopsy tests in the United Arab Emirates and select countries in the Middle East, North & Sub-Saharan Africa, and Southeast Asia region. All diagnostic testing services under this agreement will be performed in Biocept’s San Diego-based CLIA-certified laboratory with Alliance Global having responsibility for sales, marketing, distribution, and reimbursement of the Company’s liquid biopsy platform. Additional terms of the agreement were not disclosed.
InflaRx initiated at buy at BMO
BMO Capital analyst Matthew Luchini initiated InflaRX (IFRX) with an Outperform rating and a price target of $45. The analyst notes that the company’s IFX-1 “could be a best-in-class treatment for hidradenitis suppurativa” skin diseas, with initial data suggesting a “better clinical profile” than Humira. Luchini adds that the strength of IFX-1’s Phase IIa data de-risks the ongoing Phase IIb trial, also stating that “IFX-1’s targeting of C5a could be an advantage over emerging competitor avacopan” made by ChemoCentryx (CCXI).
Advaxis shares gain as FDA lifts clinical hold on its drug trial
Shares of the biotech company Advaxis Inc. ADXS, -8.27% surged 68% in premarket trade on Friday after the Food and Drug Administration lifted a clinical hold on the company’s phase 1/2 study for a cancer drug combination. The clinical hold was put in place in March after a patient death following “acute respiratory failure after nine months of combination therapy,” the company said; it will now implement new measures to detect these types of events early. The trial is testing a combination of Advaxis’ axalimogene filolisbac, a listeria-based immunotherapy, and Astrazeneca’s durvalumab AZN, +4.29% for patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer. Company shares have dropped 29.5% over the last three months, compared with a 5.4% rise in the S&P 500 SPX, +0.87% and a 2.3% rise in the Dow Jones Industrial Average DJIA, +0.91%
J&J verdict likely to increase attention on lawsuits, says Credit Suisse
After a Missouri jury on Thursday ordered Johnson & Johnson to pay $4.69B to 22 women who alleged the company’s talc-based products, including its baby powder, contain asbestos and caused them to develop ovarian cancer, Credit Suisse analyst Vamil Divan said the large number of ongoing litigations are gaining the attention of investors and is not expected to slow. Given the number of cases related to both talc and mesh and the size of the potential verdicts, Divan says it is “challenging” to put reasonable ranges on what J&J’s ultimate liability may end up being, though he notes that J&J has been able to overturn many of the cases and has appealed all of the unfavorable verdicts. Divan maintains an Outperform rating and $151 price target.
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