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FDA Places Clinical Hold On ADXS Study, ALT Proves A Good Shot, RYTM On Track

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Today's Daily Dose brings you news about the clinical hold on Advaxis' HPV-associated cancers trial; encouraging pre-clinical trial results of Altimmune's investigational SparVax-L against anthrax infection; encouraging interim data from BioSpecifics Technologies' Phase I trial of Collagenase Clostridium Histolyticum for the treatment of uterine fibroids; Breakthrough Therapy Designation for Proteostasis' cystic fibrosis drug candidate, and near-term catalysts of Rhythm Pharma.

Read on…

Advaxis Inc.'s (ADXS) phase 1/2 combination study of Axalimogene filolisbac with AstraZeneca's IMFINZI for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer has been placed on clinical hold by the FDA.

The clinical hold was implemented following a patient death, involving respiratory failure, in the trial.

Enrollment and dosing in all other Advaxis clinical programs are unaffected at this time, according to the Company.

ADXS closed Monday's trading at $2.21, up 0.45%.

A pre-clinical study comparing Altimmune Inc.'s (ALT) investigational SparVax-L with the approved vaccine BioThrax against anthrax infection has yielded encouraging data.
Data from the study showed a 67% survival rate in animals challenged with a lethal dose of anthrax after a single dose of SparVax-L and 100% survival rate after two doses.

This project has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, and the Biomedical Advanced Research and Development Authority (BARDA).

ALT closed Monday's trading at $1.74, down 0.57%.

Arch Therapeutics Inc. (ARTH.OB) is planning to submit its 510(k) notification for its medical device AC5 Topical Gel to the FDA later in the third calendar quarter of 2018.

AC5 Topical Gel is designed for hemostatic and wound care.

The Company also expects to file a CE mark in Europe for AC5 in the second half of 2018.

ARTH.OB closed Monday's trading at $0.32, down 3.73%.

BioSpecifics Technologies Corp. (BSTC) presented encouraging interim data from its ongoing Phase 1 trial of Collagenase Clostridium Histolyticum, or CCH, for the treatment of uterine fibroids at the 65th Annual Scientific Meeting of the Society for Reproductive Investigation on Friday, March 9, 2018.

The data show the safety and effectiveness of the CCH injection method in five patients, according to the Company. The Phase 1 trial will enroll a total of 15 female subjects treated prior to hysterectomy.

The interim data presented yesterday involved 5 patients. Three patients were injected with CCH and underwent a hysterectomy 24-96 hours after the injection. Two patients subsequently were injected with a higher dose of collagenase, and underwent a hysterectomy 63 days after the injection.

The collagenase-treated tissue samples showed not only a significant reduction of collagen content but also the disruption of the tissue pattern, while in control tissues the collagen remained abundant and compact. The digestion of collagen did not extend beyond the capsule of any fibroid. No adverse event occurred in these patients, added the Company.

BSTC closed Monday's trading at $43.42, up 4.43%.

Intec Pharma Ltd. (NTEC) has partnered with LTS Lohmann Therapie-Systeme AG for the manufacture of its lead product candidate, Accordion Pill Carbidopa/Levodopa (AP-CD/LD) as a treatment for the severe symptoms in advanced Parkinson's disease patients.

Under the agreement, LTS will manufacture the AP-CD/LD capsules using Intec's proprietary Accordion Pill production technology in LTS' manufacturing facility in Andernach, Germany upon the completion of assembly of the production line.

Currently, Intec is producing the AP-CD/LD capsules for its Phase 3 clinical trial at its existing manufacturing facility in Jerusalem, and will work together with LTS to establish commercial scale production capabilities for AP-CD/LD capsules.

NTEC closed Monday's trading at $6.50, down 1.52%.

Proteostasis Therapeutics Inc.'s (PTI) PTI-428, a cystic fibrosis transmembrane conductance regulator amplifier, has been granted Breakthrough Therapy Designation for the treatment of cystic fibrosis in homozygous patients for the F508del mutation who are receiving Orkambi as background therapy.

Last December, Proteostasis successfully completed its phase II study designed to evaluate the efficacy, safety, and tolerability of 50 mg once-a-day of PTI-428 over a 28-day treatment of CF patients on background Orkambi.

The Company has plans to initiate a doublet study of PTI-801 and PTI-808 in CF subjects and advance a triple combination study of PTI-428, PTI-808 and PTI-801 in CF subjects in 2018.

PTI closed Monday's trading at $4.14, up 0.49%.

Rhythm Pharmaceuticals Inc.'s (RYTM) first phase III trial of Setmelanotide in patients with POMC deficiency obesity and, a second phase III trial in patients with LEPR deficiency obesity are underway.

The third pivotal phase III trial of Setmelanotide in Bardet-Biedl Syndrome is expected to be initiated this year.

Initial data from the phase III trial of Setmelanotide in patients with POMC deficiency obesity is expected to be announced in the first half of 2019.

A phase 2 proof-of-concept basket study evaluating Setmelanotide for the treatment of patients with each of: Alström Syndrome, POMC epigenetic disorders, and POMC heterozygous deficiency obesity, is also ongoing. Initial data in each indication is expected to be announced in the first half of 2018.

Rhythm expects to initiate a pivotal Phase 3 clinical trial evaluating Setmelanotide in Bardet-Biedl Syndrome in 2018.

RYTM closed Monday's trading at $27.34, up 0.22%.

Dual-listed VBI Vaccines Inc. (VBIV) (VBV.V) has applied to voluntarily delist its common shares from the Toronto Stock Exchange due to the very limited trading activity of the Company's Shares on the TSX.

The delisting from TSX will become effective at the close of trading on March 23, 2018.

The Company's shares will continue to be listed and traded on NASDAQ, under its current symbol "VBIV", and its Canadian shareholders will be able to continue to trade through their brokers on that exchange.

VBIV closed Monday's trading at $4.06, unchanged from previous day's close.

Viemed Healthcare Inc.'s (VMD.V) annual revenue for 2017 has grown to $46.9 million, up 50% over the prior year. (all dollar amounts are USD)

The Company had a working capital balance of $4 million as of December 31, 2017 and total long-term debt of $800,000. This, along with the $5 million of unused line of credit, provides a stable liquidity profile, noted Viemed.

Looking ahead, the Company expects to generate total revenues of approximately $14.0 - $14.3 million during the first quarter of 2018, an increase of approximately 41% over the first quarter of 2017.

VMD.V closed Monday's trading at C$3.06, up 2.68%.

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